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Diabetic foot disease: a systematic literature review of patient-reported outcome measures
- 1 Department of Nursing and Podiatry, University of Málaga, Arquitecto Francisco Peñalosa, s/n. Ampliación campus de Teatinos, 29071, Málaga, Spain.
- 2 Department of Nursing and Podiatry, University of Málaga, Arquitecto Francisco Peñalosa, s/n. Ampliación campus de Teatinos, 29071, Málaga, Spain. [email protected]
- 3 Podiatry Department, Faculty of Health Sciences, Block A, Level 1, Mater Dei Hospital, University of Malta, Msida, MSD 2090, Malta.
- 4 Department of Physiotherapy, University of Málaga, Arquitecto Francisco Peñalosa, s/n. Ampliación campus de Teatinos, 29071, Málaga, Spain.
- PMID: 34109501
- DOI: 10.1007/s11136-021-02892-4
Purpose: Diabetic foot disease is one of the most serious and expensive complications of diabetes. Patient-reported outcome measures (PROMs) analyse patients' perception of their disability, functionality and health. The goal of this work was to conduct a systematic review regarding the specific PROMs related to the evaluation of diabetic foot disease and to extract and analyse the values of their measurement properties.
Methods: Electronic databases included were PubMed, CINAHL, Scopus, PEDro, Cochrane, SciELO and EMBASE. The search terms used were foot, diabet*, diabetic foot, questionnaire, patient-reported outcome, self-care, valid*, reliabil*. Studies whose did not satisfy the Critical Appraisals Skills Programme (CASP) Diagnostic Study Checklist were excluded. The measurement properties extracted were: Internal Consistency, Test-retest, Inter-rater and Intra-rater, Standard Error of Measurement, Minimum Detectable Measurement Difference, Content Validity, Construct Validity, Criterion Validity and Responsiveness.
Results: The PROMs selected for this review were 12 questionnaires. The Diabetic foot self-care questionnaire (DFSQ-UMA) and the Questionnaire for Diabetes Related Foot Disease (Q-DFD) were the PROMs that showed the highest number of completed measurement properties.
Conclusion: According to the results, it is relevant to create specific questionnaires for the evaluation of diabetic foot disease. It seems appropriate to use both DFSQ-UMA and Q-DFD when assessing patients with diabetic foot disease.
Keywords: Diabetes; Diabetes complications; Evidence; Questionnaire; Review.
© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
- Patient-Reported Outcome Measures of Quality of Life in People Affected by Diabetic Foot: A Psychometric Systematic Review. Romero-Collado À, Hernández-Martínez-Esparza E, Zabaleta-Del-Olmo E, Urpí-Fernández AM, Santesmases-Masana R. Romero-Collado À, et al. Value Health. 2022 Sep;25(9):1602-1618. doi: 10.1016/j.jval.2022.04.1737. Epub 2022 Jun 1. Value Health. 2022. PMID: 35659485
- Psychometric evaluation of the Persian version of the diabetic foot self-care questionnaire in Iranian patients with diabetes. Mahmoodi H, Abdi K, Navarro-Flores E, Karimi Z, Sharif Nia H, Gheshlagh RG. Mahmoodi H, et al. BMC Endocr Disord. 2021 Apr 17;21(1):72. doi: 10.1186/s12902-021-00734-5. BMC Endocr Disord. 2021. PMID: 33865367 Free PMC article.
- Measurement properties of the most commonly used Foot- and Ankle-Specific Questionnaires: the FFI, FAOS and FAAM. A systematic review. Sierevelt IN, Zwiers R, Schats W, Haverkamp D, Terwee CB, Nolte PA, Kerkhoffs GMMJ. Sierevelt IN, et al. Knee Surg Sports Traumatol Arthrosc. 2018 Jul;26(7):2059-2073. doi: 10.1007/s00167-017-4748-7. Epub 2017 Oct 12. Knee Surg Sports Traumatol Arthrosc. 2018. PMID: 29026933 Review.
- Systematic review of the psychometric properties of patient-reported outcome measures for rheumatoid arthritis in the foot and ankle. Ortega-Avila AB, Ramos-Petersen L, Cervera-Garvi P, Nester CJ, Morales-Asencio JM, Gijon-Nogueron G. Ortega-Avila AB, et al. Clin Rehabil. 2019 Nov;33(11):1788-1799. doi: 10.1177/0269215519862328. Epub 2019 Jul 10. Clin Rehabil. 2019. PMID: 31291785
- Instruments of Choice for Assessment and Monitoring Diabetic Foot: A Systematic Review. Fernández-Torres R, Ruiz-Muñoz M, Pérez-Panero AJ, García-Romero J, Gónzalez-Sánchez M. Fernández-Torres R, et al. J Clin Med. 2020 Feb 24;9(2):602. doi: 10.3390/jcm9020602. J Clin Med. 2020. PMID: 32102313 Free PMC article. Review.
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- Content Validity of Patient-Reported Outcome Measures Developed for Assessing Health-Related Quality of Life in People with Type 2 Diabetes Mellitus: a Systematic Review. Terwee CB, Elders PJM, Langendoen-Gort M, Elsman EBM, Prinsen CAC, van der Heijden AA, de Wit M, Beulens JWJ, Mokkink LB, Rutters F. Terwee CB, et al. Curr Diab Rep. 2022 Sep;22(9):405-421. doi: 10.1007/s11892-022-01482-z. Epub 2022 Jul 11. Curr Diab Rep. 2022. PMID: 35819705 Free PMC article. Review.
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- Published: 04 June 2020
Footwear and insole design features that reduce neuropathic plantar forefoot ulcer risk in people with diabetes: a systematic literature review
- Sayed Ahmed ORCID: orcid.org/0000-0002-9049-6825 1 ,
- Alex Barwick 1 ,
- Paul Butterworth 1 &
- Susan Nancarrow 1
Journal of Foot and Ankle Research volume 13 , Article number: 30 ( 2020 ) Cite this article
In people with diabetes, offloading high-risk foot regions by optimising footwear, or insoles, may prevent ulceration. This systematic review aimed to summarise and evaluate the evidence for footwear and insole features that reduce pathological plantar pressures and the occurrence of diabetic neuropathy ulceration at the plantar forefoot in people with diabetic neuropathy.
Six electronic databases (Medline, Cinahl, Amed, Proquest, Scopus, Academic Search Premier) were searched in July 2019. The search period was from 1987 to July 2019. Articles, in English, using footwear or insoles as interventions in patients with diabetic neuropathy were reviewed. Any study design was eligible for inclusion except systematic literature reviews and case reports. Search terms were diabetic foot, physiopathology, foot deformities, neuropath*, footwear, orthoses, shoe, footwear prescription, insole, sock*, ulcer prevention, offloading, foot ulcer, plantar pressure.
Twenty-five studies were reviewed. The included articles used repeated measure ( n = 12), case-control ( n = 3), prospective cohort ( n = 2), randomised crossover (n = 1), and randomised controlled trial (RCT) ( n = 7) designs. This involved a total of 2063 participants. Eleven studies investigated footwear, and 14 studies investigated insoles as an intervention. Six studies investigated ulcer recurrence; no study investigated the first occurrence of ulceration. The most commonly examined outcome measures were peak plantar pressure, pressure-time integral and total contact area. Methodological quality varied. Strong evidence existed for rocker soles to reduce peak plantar pressure. Moderate evidence existed for custom insoles to offload forefoot plantar pressure. There was weak evidence that insole contact area influenced plantar pressure.
Rocker soles, custom-made insoles with metatarsal additions and a high degree of contact between the insole and foot reduce plantar pressures in a manner that may reduce ulcer occurrence. Most studies rely on reduction in plantar pressure measures as an outcome, rather than the occurrence of ulceration. There is limited evidence to inform footwear and insole interventions and prescription in this population. Further high-quality studies in this field are required.
Peer Review reports
Foot ulcers are a common consequence of diabetes due to the development of peripheral neuropathy, peripheral vascular disease, limited joint mobility and foot deformity [ 1 , 2 , 3 , 4 , 5 , 6 ]. Nearly 34% of persons with diabetes will develop a foot ulcer in their lifetime [ 7 ]. This can lead to infection and amputation; diabetes is the main reason for non-traumatic lower limb amputation [ 8 , 9 ]. Previous foot ulcer or amputation is a risk of future amputation [ 1 , 3 , 5 , 10 ]. Additional risk factors include higher Body Mass Index (BMI), and structural foot deformities [ 2 , 3 , 4 , 6 ], such as hammertoes and hallux valgus [ 11 , 12 ].
Diabetic peripheral neuropathy (DPN) is the central risk factor for the development of plantar foot ulceration [ 13 ]. Over 30% of persons with diabetes will develop DPN [ 14 ], the incidence increasing with age [ 15 , 16 ]. DPN can affect the autonomic, sensory and motor nervous systems. Sensory neuropathy interrupts the protective feedback mechanism of touch and pain [ 17 ]. Motor neuropathy results in compromised muscle innervation, reduction in strength, and combined with limited joint mobility, the development of foot deformities. These deformities may lead to an increase in plantar foot pressures, particularly in the forefoot [ 18 , 19 , 20 , 21 ]. Autonomic neuropathy leads to diminished sweating and changes to skin perfusion, leading to dry skin and hyperkeratosis. As skin integrity is compromised, patients are more susceptible to trauma which may precipitate a diabetic foot ulcer [ 21 , 22 , 23 , 24 ].
Neuropathic ulcers in diabetic feet occur mostly at the plantar forefoot [ 11 , 25 , 26 ] and correspond to areas of peak plantar pressure [ 27 ]. Bennetts et al. [ 28 ] demonstrated that most peak pressure areas are located in the forefoot regions in this population. Limited range of motion at the forefoot joints is also likely to contribute to the peak plantar pressures (PPP) observed in this region [ 29 ]. For this reason, plantar pressure mapping is used to guide footwear and insole manufacture and judge their effectiveness [ 30 ].
Reducing plantar pressures is considered a key factor for wound healing and prevention of ulcer recurrence [ 31 , 32 ]. Footwear and insoles are an essential treatment modality for offloading these pressures [ 33 , 34 ]. The desired offloading threshold should be > 30% reduction in dynamic in-shoe plantar pressure from the baseline or < 200 kPa to ensure ulcer-free survival at the forefoot [ 35 ]. This systematic review aimed to summarise and evaluate the evidence for footwear and insole features that reduce pathological plantar pressures and the occurrence of diabetic neuropathy ulceration at the plantar forefoot in people with diabetic neuropathy.
The systematic search was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Statement [ 36 ].
In July 2019, six electronic databases were searched (Medline, Cinahl, Amed, Proquest, Scopus, Academic Search Premier) using medical subject headings followed by a keyword subject heading. The search period was from 1987 to July 2019. The search terms can be seen in Fig. 1 and Supplementary file 1 .
Search terms used to select the studies
All studies included in the systematic review were obtained from full-text peer-reviewed journals published in English. Studies that did not use footwear or insole as a mode of intervention for long term offloading were excluded. Letters to the editor, opinion pieces, conference proceedings, and editorials were also excluded. All study designs except systematic reviews and case reports were eligible for inclusion. The titles and abstracts of the articles were screened by one reviewer (SA). Full-text articles were reviewed based on the following criteria: i, participants were adult (> 18 years), had diabetes; ii, all or some of the participants had neuropathy and foot deformity, history of plantar forefoot ulcers but no Charcot foot, history of heel ulcer or active foot ulcers; iii, studies used footwear or insoles as a long-term offloading intervention; iv, the outcome of the study was either (re)occurrence of forefoot ulcer or change in forefoot plantar pressure outcomes; v, the footwear or insole interventions had to be sufficiently described to be able to draw useful conclusions; vi, conventional materials and manufacturing techniques were used; and vii, closed-in footwear was used. The reference lists of studies obtained through the database search were also searched to identify relevant citations.
Quality assessment was performed independently by two reviewers (SA and AB). The quality assessment form was adapted from the McMaster Critical Review Form – Quantitative Studies [ 37 ].
The literature search identified 1787 articles. Twenty-five articles met the eligibility criteria to be included in the review (Fig. 2 ). The study designs included repeated measures ( n = 12), case-control ( n = 3), prospective cohort ( n = 2), randomised crossover (n = 1), and RCT ( n = 7) studies.
PRISMA Study Selection Flow Diagram
Study characteristics are shown in Tables 1 and 2 .
Participants and settings
The participants were over 18 years of age, and the sample sizes ranged from 10 to 299. All participants in treatment groups had diabetes, and the majority had neuropathy. Participants had active or healed plantar foot ulcers, amputation, foot deformities, increased barefoot plantar pressure, or peripheral vascular disease. Most (88%) of the studies recruited participants from developed countries within high-risk foot clinics and 12% from developing countries [ 63 ]. Study duration ranged from a single session to 5 years.
Eleven studies [ 30 , 38 , 39 , 51 , 52 , 56 , 57 , 58 , 60 , 61 ] used footwear and insoles as the intervention. Of these, three studies [ 38 , 57 , 61 ] used footwear which was manufactured according to a consensus-based algorithm proposed by Dahmen et al. [ 53 ]. One study [ 52 ] specifically examined footwear rocker sole profiles. High footwear upper design feature was investigated by one study [ 51 ], and it reported that higher upper increased contact area but did not improve pressure reduction at the forefoot area.
Fourteen studies [ 30 , 38 , 39 , 40 , 42 , 44 , 46 , 48 , 49 , 51 , 53 , 58 , 61 , 62 ] reported on the prescribers, manufacturers and modifiers of the therapeutic footwear and insoles. The footwear prescribers reported in the studies were rehabilitation physicians [ 30 , 38 ], diabetologist, podologist [ 61 ], podiatric physician [ 49 ]. The manufacturers for therapeutic footwear were orthopaedic shoe technicians [ 30 , 38 , 39 , 51 , 61 ], and orthopaedic shoemakers [ 40 , 42 , 58 ], where orthopaedic shoe technicians have similar training like certified pedorthists [ 30 ]. Reported insole manufacturers or modifiers were orthotic technician [ 53 ], pedorthist [ 44 , 49 ], pedorthist or orthotist [ 46 , 48 , 49 , 62 ].
Fourteen studies [ 40 , 42 , 44 , 46 , 47 , 48 , 49 , 50 , 53 , 54 , 55 , 59 , 62 , 64 ] used insoles as a primary intervention in standardised or participant’s footwear. All studies reported on the type of footwear they used with varying descriptions of the design features and almost all studies reported on the description of insole design features used by the studies respectively, except Preece et al. [ 52 ]. Studies that are focused on the insole as a primary intervention has used prefabricated extra-depth footwear or regular retail footwear [ 40 , 42 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 53 , 54 , 55 , 62 ].
Insole features have been described by some studies [ 39 , 41 , 45 , 47 , 49 , 50 , 53 , 54 , 56 , 59 , 60 , 62 , 64 ] such as base, mid-layer, and top cover materials. The same authors also assessed hardness, thickness, casting and manufacturing technique, metatarsal dome or metatarsal bar, and arch support. Ten studies [ 40 , 41 , 42 , 47 , 48 , 53 , 55 , 56 , 59 , 64 ] examined insole material thickness and hardness. Other components of insole configurations reported were application of metatarsal pad, metatarsal dome, or metatarsal bar [ 30 , 39 , 40 , 42 , 44 , 46 , 47 , 48 , 53 , 57 , 61 ] and their positioning [ 42 , 44 , 46 , 47 , 48 , 53 ], arch support [ 30 , 39 , 40 , 42 , 51 , 53 , 55 , 57 , 61 ], top cover [ 30 , 39 , 42 , 49 , 50 , 51 , 53 , 54 , 55 , 56 , 57 , 59 , 61 , 62 , 64 ], adding local cushion to insole [ 39 , 49 , 57 , 61 , 62 ]. The size of the metatarsal dome or pad used by the studies is between 5 to 11 mm [ 42 , 44 , 47 ] in height, 66 to 74 mm in length, and 51 to 63 mm width [ 44 ]. The positioning of the metatarsal dome, bar or pad was between 5 to 10.6 mm proximal to MTHs [ 42 , 44 , 46 ] and at a line of 77% of PPP [ 47 ]. The size of extra arch support was 5 mm thick Lunalastic (NORA Freudenberg GmbH, Weinheim, Germany) in addition to arch support resulted from the casting technique [ 42 ]. Casting techniques for custom-insoles making, insole design, and manufacturing processes also have been reported by some studies [ 40 , 47 , 49 , 54 , 55 , 62 ].
Eighteen studies [ 30 , 38 , 39 , 40 , 41 , 42 , 44 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 64 ] measured PPP as the primary outcome, and the majority measured this in-shoe. Most of the studies [ 30 , 38 , 39 , 47 , 50 , 52 , 53 , 57 , 64 ] used 200 kPa as an upper threshold to classify the intervention as successful offloading the foot. The remaining studies compared a baseline pressure assessment without the intervention to peak pressure reductions with the interventions. PTI and Force Time Integral (FTI) had also been assessed as a parallel outcome measure in some studies [ 40 , 48 , 49 , 50 , 51 , 53 , 55 ]. Other studies [ 50 , 51 , 55 , 64 ] also measured contact area and soft tissue thickness (STT) [ 46 , 48 ] as a parallel outcome. Some single parameters measured by the studies were maximum force, contact area [ 64 ], and walking convenience [ 42 ]. One study [ 41 ] reported foot-sole hardness as an indicator and reduction in shore hardness value. Six studies [ 56 , 57 , 58 , 59 , 60 , 61 ] reported ulcer recurrence as a primary outcome measure and another study [ 62 ] reported on ulcerative and non-ulcerative lesions as the primary outcome. Three studies [ 57 , 58 , 60 ] measured patient adherence in their study as a secondary outcome.
The Pedar-X system (Novel GmbH, Germany) was the most commonly used in-shoe plantar pressure measuring device by studies [ 30 , 38 , 39 , 40 , 45 , 47 , 49 , 50 , 54 , 57 ] followed by the F-Scan system (Tekscan Inc. USA) [ 42 , 44 , 46 , 48 , 53 , 55 ]. Other systems included RS Scan system (RSScan, Ole, Belgium) [ 51 ]. Charanya et al. [ 41 ] used a pedobarograph system developed by Patil et al. [ 65 , 66 , 67 ] to capture the walking foot pressure image and data analysis.
The sensor’s thickness of the Pedar-X system is 2 mm [ 39 , 40 ], F-Scan 0.18 mm [ 55 ], and RS Scan 0.7 mm [ 51 ]. Both sensors of Pedar-X and F-Scan collect pressure data at 50 Hz [ 44 , 47 ], and both have four sensors per cm 2 [ 38 , 53 ]. RS Scan sensors collect data at 500 Hz [ 51 ]. Studies using Pedar-X systems used steps between 20 to 40 [ 40 , 47 , 49 , 54 ] and 10 to 20 m walk-way [ 38 , 45 , 49 ]. Studies using F-Scan systems used walk-way length between 6.1 to 10 m [ 44 , 55 ]. RS Scan collected dynamic in-shoe pressure data for 8 s (10–16 steps) [ 51 ].
Reductions in forefoot plantar pressure
Arts et al. [ 38 ] reported on the effectiveness of footwear and insole design based on the algorithm proposed by Dahmen et al. [ 68 ]. The rate of pressure reduction was lower at the metatarsals area (29–50%) compared to midfoot (81%) and known ulcer location (62%) [ 38 ] when footwear and insoles are designed according to Dahmen’s algorithm.
Sole design (rocker sole) was the most reported design feature and some reported on detailed configurations such as rocker apex position [ 30 , 38 , 41 , 50 , 51 , 52 , 56 , 61 ], rocker apex angle [ 52 ], rocker angle [ 30 , 51 , 52 , 60 ], rigidity or hardness [ 30 , 38 , 41 , 42 , 53 , 56 , 60 , 61 ] and, material type [ 41 , 50 , 51 , 60 , 61 ]. A rocker sole configuration with apex position at 52% of the footwear length, 20° rocker angle, and 95° apex angle can yield peak pressure < 200 kPa in 71–81% cases [ 52 ].
Some studies reported on footwear upper design features, such as upper height (high footwear 16 cm, Bottine 12.5 cm, Low footwear (6.5 cm) [ 38 , 51 , 61 ], footwear depth [ 39 , 50 , 56 , 57 , 60 , 64 ], leg and tongue profile [ 38 , 57 , 61 ]. Other design features are; upper material, collar, lining, toe puff [ 50 , 56 , 60 ], heel counter, fastening system [ 53 , 60 ] and active heel height [ 51 ].
Non-weight-bearing (NWB) casting technique yields more effective custom-made insoles to offload the hallux region and semi-weight-bearing (SWB) casting technique is more effective to offload 1–3 metatarsal heads (MTHs) [ 55 ]. The NWB insoles also yield the highest arch support comparing to insoles made by other casting techniques [ 55 ].
Insoles designed based on foot shape and plantar pressure data are more effective to offload the forefoot region compared to insoles designed based on foot shape only [ 49 , 54 , 62 ]. The outcome can be between 32 to 21% improvement from shape-only and traditionally manufactured insoles out of polypropylene base [ 49 ].
Custom-made insoles with multi-density, softer materials have demonstrated improved forefoot offloading compared to higher-density EVA (55° shore A). Extra arch support, metatarsal pads, a plastazote top cover, and local cushioning can further reduce plantar forefoot pressure [ 42 , 64 ]. Metatarsal pad, local cushion and a plastazote top cover can reduce peak pressure by 14 to 15.9% on their own. A plastazote top cover combined with a metatarsal pad and local cushioning reduces 24 and 22% PPP at the forefoot [ 39 ].
Reductions in ulcer recurrence
López-Moral et al. [ 60 ] explored the effect of two rocker soles: semi-rigid (Wellwalk technology with Vibram Strips) and rigid on the recurrence of ulceration. By using, a rigid rocker sole the risk of re-ulceration at the forefoot was reduced by 64% when compared with semi-rigid rocker sole footwear.
Busch et al. [ 56 ] examined the effect of two different footwear (Lucro stock diabetic footwear versus regular retail footwear) with insoles on ulcer relapse of 92 participants with high-risk neuropathic feet at 12 and 42 months. The footwear was available in three different widths with differing features: rocker bottom outsoles and soft upper with three layers. This combined footwear and insoles reduced ulcer relapse by 45% compared with standard footwear within the first year.
Rizzo et al. [ 61 ] compared a treatment group who were given therapeutic footwear designed as per Dahmen et al. [ 57 , 68 ] and custom-made insoles to a control group who received standard footwear. The participants were assessed for ulcer occurrence and relapse at 12, 36 and 60 months. Ulcer relapse rates were significantly lower (11.5% versus 38.6% at 12 months, 17.6% versus 61% at 36 months and 23.5% versus 72% at 60 months) in the treatment group than controls.
Lavery et al. [ 59 ] examined the effect of shear-reducing insoles on ulcer recurrence when compared with standard insoles in the same style of footwear. Shear-reducing insoles were 3.5 times less likely to create ulcers in the study participants compared to the standard insoles, although, both insole types demonstrated equivalent plantar pressure reduction [ 69 ].
In another study [ 57 ] based on the algorithm proposed by Dahmen et al. [ 57 , 68 ] the treatment group received custom-made footwear that was adjusted following in-shoe pressure analysis. Controls received custom-made footwear without the in-shoe pressure analysis. The primary outcome was ulcer relapse after 18 months. The outcomes were not significantly different due, in part, to variance in patient adherence.
Footwear and insoles are complex biomechanical interventions due to variance in design, materials, manufacturing methods, individual preferences and rates of adherence. This complexity is compounded when it is considered alongside the range of foot pathologies that co-exist with diabetes. Forefoot structural deformities are prevalent in this patient group [ 11 , 12 ] increasing in-shoe plantar pressure at the metatarsal heads. The importance of footwear and insoles in offloading PPP for preventing plantar forefoot foot ulceration is well documented [ 70 , 71 ]. However, the specifications of design parameters and materials that can reduce PPP at the forefoot area are not precise. Reduction of PPP is one of the major factors to reduce the risk of ulcer occurrence and recurrence. This review explores the identification of critical design features and materials used in footwear and insole manufacturing that can reduce PPP at the forefoot and prevent ulcer occurrence and recurrence. Summery of those features that are available in the literature has been presented in Appendix 1 and 2 .
Several studies have suggested rocker sole profile as the most recommended design to offload PPP at the forefoot [ 30 , 39 , 51 , 52 , 56 , 60 , 61 ]. The studies showed strong evidence for the rocker sole with evidence pointing towards specific variations of the rocker sole: such as apex position, apex angle, rocker angle and rigidity of sole materials. An RCT [ 60 ] showed that a rocker sole configuration with the pivot point under the metatarsal heads and rigid sole materials improve plantar pressure offloading at the forefoot compared to rocker sole made with semi-rigid materials. In a 6 month follow-up, the plantar ulcer recurrence rate was 23 and 64% among the experimental and control group where sole rigidity was the only variant. Preece et al. [ 52 ] and Praet et al. [ 51 ] compared apex position and rocker angle for rocker sole design in their studies. They recommended an apex position at 52–63% of shoe length and rocker angle of 20–23 0 to provide effective offloading at the forefoot (< 200 kPa), finding it more effective than any other lower or higher values of those respective parameters.
Arts et al. [ 38 ] in the Netherlands and Rizzo et al. [ 61 ] in Italy tested the effect of footwear design suggested by the consensus-based algorithm proposed by Dahmen et al. [ 68 ]. The key footwear design features in Dahmen algorithm are based on medical conditions. For example, the recommendations for a person with diabetes and history of neuropathic ulcers are footwear with a high upper (above ankle boots), stiffened tongue and leg uppers, rigid rocker soles with early pivot point. Both studies used above-ankle boots with custom-made insoles to offload pressure at the forefoot area. Both studies found that footwear and insoles designed according to this algorithm, are effective in offloading the neuropathic diabetic foot. However, Arts and colleagues [ 38 ] found that the algorithm is not as effective for footwear specifications to offload plantar pressure at the metatarsal heads.
There is a lack of guidance in the literature on footwear modifications that offload the forefoot. Footwear modification (also known as footwear customisation or optimisation) is common in both prefabricated and fully custom-made footwear. Most frequent footwear modifications are a re-configuration of rocker sole profile, such as early or significant pivot point (rocker angle) and stiffening the outer sole [ 30 , 39 ]. Footwear modification success (≤200 kPa) is least at the forefoot [ 38 , 39 ]. Bus et al. [ 30 ] recommended in-shoe plantar pressure analysis as an effective tool to guide the modifications for offloading the target regions in the neuropathic foot.
Insole modification features include local cushioning, replacing top covers with plastazote and applying a new or re-positioning existing metatarsal bars and metatarsal domes [ 30 , 39 , 47 , 61 ], removing plugs, and adding arch supports [ 61 , 64 ]. These are the most effective (PPP reduced ≤200 kPa) modifications in offloading or reducing PPP in targeted regions [ 30 , 39 ]. The targeted regions were determined by the history of ulceration or from PPP measurements data. These modifications in the insole are proven to be effective in offloading plantar pressure at an optimal level. However, they are least effective in offloading pressure at the metatarsal heads [ 38 , 39 ].
Pedorthists commonly use a higher upper height in their treatment of neuropathic forefoot ulcers. Dahmen et al. [ 68 ] and Diabetic Foot Australia (DFA) guideline [ 34 ] support such practice. However, Praet et al. [ 51 ] showed that high-ankle boots did not influence plantar pressure offloading when compared with low cut footwear. The authors suggest that although high-ankle boots do not change plantar pressures, they may reduce shear forces inside the shoe at the forefoot by increasing contact area around the ankle. Considering these findings, further studies assessing high-ankle boots will help to inform clinicians working in this field.
Many design features were not examined in the literature. Higher quality research is required to scientifically examine other important footwear design parameters, including heel height, toe height, upper materials, sole materials, heel counters, and closure systems for this therapeutic target.
There was moderate evidence [ 72 ] to suggest using total contact insoles [ 49 , 55 , 61 , 62 ], metatarsal pads [ 40 , 44 , 46 , 48 , 62 ], metatarsal bars [ 47 , 61 ] and plastazote top covers [ 39 ] to reduce PPP. Arts et al. [ 39 ] recommended plastazote as a top cover over leather due to its superiority in peak pressure offloading, but they need to be replaced every 6 months. Two studies [ 50 , 53 ] also included prefabricated insoles as interventions, which also showed a reduction in forefoot plantar pressure.
In practice, the use of custom-made insoles over prefabricated devices needs to be considered in relation to cost versus benefit. Paton and colleagues [ 50 ] used two different insoles, made out of EVA and Poron, and compared cost as well. Custom devices were 18% higher cost in delivery than prefabricated insoles. The main difference was where the foot was cast to make the insoles, or insoles were selected from stock. There was no significant difference in PPP reduction between the two types of insoles. Custom-made insoles were, however, found to reduce PTI more than prefabricated insoles and lasted longer [ 50 ]. Customised devices may be preferred in practice as they account for structural changes in the diabetic foot, which is likely the reason that they reduce PTI more than prefabricated devices. Other studies [ 30 , 40 , 46 , 48 , 53 , 55 ] that compared PPP reduction capacity of the custom-made insoles with prefabricated insoles and not examined the cost, those found custom-made insoles to be more effective in pressure offloading in almost every region of the foot.
Most common insole base materials are EVA with the hardness of 50–55 0 Shore A and 30–35 0 Shore A [ 47 , 53 ] and the latter material showed improved performance in offloading PPP. However, the medium-density EVA base (30–35 0 Shore A) insoles need more frequent replacement than the higher density EVA group insoles due to material fatigue.
PPT or Poron as mid-layer [ 56 ] and top cover materials either MCR, plastozote or microfiber are effective in plantar forefoot pressure offloading. PPT or Poron is also used as a top cover in some insole designs [ 56 , 64 ]. Use of a leather top cover is of limited benefit due to its poor pressure reduction capacity [ 39 ].
None of the studies looked at the prevention of initial neuropathic plantar forefoot ulcer occurrence rather than a subsequent recurrence ulcer. Additionally, studies did not assess forefoot ulceration in isolation, but whole foot ulceration. PPP reduction in different regions requires different types of offloading. Further, different footwear and insole design features show differences in pressure reduction efficacy in different regions of the foot. The articles relied on in-shoe plantar pressure measurement data as a predictor of ulceration. However, other factors such as co-morbidity and lack of adherence to treatment also contribute to ulcer occurrence.
Plantar tissue stress incorporates vertical plantar pressure, horizontal shear pressure, and the frequency at which it is applied [ 73 ]. The reliance on plantar pressures as a predictor of ulceration may, therefore, be only one part of the picture. Lavery et al. [ 59 , 69 ] reported that two different insoles (shear-reducing and standard insoles) with equivalent plantar pressure reduction capacity could have a significantly different outcome in ulcer recurrence where shear-reducing is the only differentiation factor. Shear-reducing insoles had 3.5 times higher ulcer prevention capacity than the standard insoles in the study participants. Since design features are likely to influence footwear function, and therefore, adherence, it is important to consider which features may prevent ulceration.
There is limited data in the literature to determine the efficacy of footwear in preventing ulcer occurrence. Preece et al. [ 52 ] and Martinez-Santos et al. [ 47 ] explored the efficacy of footwear and insole design features, but could not make any recommendations for preventing ulcer occurrence.
In this review, the articles were excluded if the participants had heel ulcer, Charcot foot or any active, dorsal foot ulcers, and these might limit the representation of complete diabetic foot conditions. This may limit the footwear and insole feature recommendations for those feet that have those conditions.
Heterogeneity in study designs, interventions, outcome measures and footwear and insoles design features make it also very difficult to come into a conclusion. Greater variations in participant’s inclusion criteria and foot deformities, footwear and insole types, their measuring, casting and designing techniques, in-shoe pressure analysis systems may result in inconsistent data. Hence, we can not make a clear comparison or pool data to analyse further.
Because of the need to customise to the individual, the success of custom-made footwear as an intervention in offloading the plantar foot is dependent on the knowledge and skills of the prescribers and manufacturers [ 30 , 40 , 55 ]. The studies in this review used a variety of skilled practitioners in these roles such as orthopaedic shoemakers, pedorthists depending on the region. The presence of these practitioners in the interdisciplinary team approach in high-risk foot services is increasingly recognised ([ 34 ], http://nadc.net.au/foot-network/ ).
Several studies [ 30 , 42 , 50 , 57 , 60 , 61 ] explored patient satisfaction and adherence to wearing footwear and insoles. Patient adherence to wearing therapeutic footwear is vital to ensure improved offloading and ulcer prevention [ 57 , 60 , 61 ]. No difference was found in patients’ perceptions of custom-made versus prefabricated insoles [ 50 ]. Adding arch support and large metatarsal domes to basic insoles reduces patient adherence and walking comfort, despite evidence that these features improve pressure offloading [ 42 ].
Studies did not report the factors that influence adherence to therapy, which also limits the application of our findings. Consideration of patient expectations, effective education on footwear and activity-specific device designs are limited in the literature. Studies also did not consider geographical and socioeconomic factors. Most studies [ 30 , 38 , 39 , 42 , 47 , 48 , 50 , 51 , 52 , 53 , 56 , 57 , 60 , 61 ] were carried out in developed countries [ 63 ] with climates conducive to using ankle-high boots. Also, the practicality of these ankle-high boots for countries with warmer climates needs revisiting concerning patient adherence.
There was no study to take a personalised-treatment approach to focus on an individual’s need or preference to increase adherence. Footwear is a very personal item, and a pre-study participant’s feedback on their future footwear is crucial as opposed to only post-study feedback as adherence plays a vital role in an individual’s outcome [ 51 , 57 , 58 , 60 ]. Study designs like the N-of-1 or single-patient-trial design [ 74 , 75 ] may bridge the gap in the literature.
Appropriate footwear design that takes into consideration the needs of low-income countries and those with warmer climates are limited in the literature, even though the prevalence of diabetes tend to be higher among the populations in these regions [ 76 ].
There is limited evidence to inform footwear and insole interventions, especially in conjunction with in-shoe plantar pressure reduction. The available evidence supports the identification of footwear and insole design and modification parameters that can influence forefoot plantar pressure reduction. Prevention of ulcer occurrence or recurrence at the plantar forefoot region in diabetic patients is limited. Further research is needed to improve care for people with diabetic foot ulceration.
Availability of data and materials
The author can be contacted for any data requests.
Randomised controlled trial
Preferred reporting items for systematic reviews and meta-analysis
Body mass index
Diabetic peripheral neuropathy
Peak plantar pressure
Pressure time integral
Soft tissue thickness
Diabetic foot Australia
High-risk foot services
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Ahmed, S., Barwick, A., Butterworth, P. et al. Footwear and insole design features that reduce neuropathic plantar forefoot ulcer risk in people with diabetes: a systematic literature review. J Foot Ankle Res 13 , 30 (2020). https://doi.org/10.1186/s13047-020-00400-4
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DOI : https://doi.org/10.1186/s13047-020-00400-4
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Preventing foot ulceration in diabetes: systematic review and meta-analyses of RCT data
- Fay Crawford ORCID: orcid.org/0000-0002-0473-9959 1 , 2 ,
- Donald J. Nicolson 1 ,
- Aparna E. Amanna 1 ,
- Angela Martin 1 ,
- Saket Gupta 1 ,
- Graham P. Leese 3 ,
- Robert Heggie 4 ,
- Francesca M. Chappell 5 &
- Heather H. McIntosh 6
Diabetologia volume 63 , pages 49–64 ( 2020 ) Cite this article
Foot ulceration is a serious complication for people with diabetes that results in high levels of morbidity for individuals and significant costs for health and social care systems. Nineteen systematic reviews of preventative interventions have been published, but none provides a reliable numerical summary of treatment effects. The aim of this study was to systematically review the evidence from RCTs and, where possible, conduct meta-analyses to make the best possible use of the currently available data.
We conducted a systematic review and meta-analysis of RCTs of preventative interventions for foot ulceration. OVID MEDLINE and EMBASE were searched to February 2019 and the Cochrane Central Register of Controlled Trials to October 2018. RCTs of interventions to prevent foot ulcers in people with diabetes who were free from foot ulceration at trial entry were included. Two independent reviewers read the full-text articles and extracted data. The quality of trial reporting was assessed using the Cochrane Risk of Bias tool. The primary outcome of foot ulceration was summarised using pooled relative risks in meta-analyses.
Twenty-two RCTs of eight interventions were eligible for analysis. One trial of digital silicone devices (RR 0.07 [95% CI 0.01, 0.55]) and meta-analyses of dermal infrared thermometry (RR 0.41 [95% CI 0.19, 0.86]), complex interventions (RR 0.59 [95% CI 0.38, 0.90], and custom-made footwear and offloading insoles (RR 0.53 [95% CI 0.33, 0.85]) showed beneficial effects for these interventions.
Four interventions were identified as being effective in preventing foot ulcers in people with diabetes, but uncertainty remains about what works and who is most likely to benefit.
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Foot ulceration is a serious complication of diabetes that can result in high levels of morbidity for individuals and burdens health and social care systems with huge costs [ 1 , 2 ]. Predicting those people most likely to develop a foot ulcer has been the subject of much research and the independent risk factors have been established [ 3 , 4 ]. However, the value of prediction models to inform treatment decisions depends on the availability of effective interventions to modify risk [ 5 ].
As part of a wider research project to create a cost-effective, evidence-based pathway for assessing and managing the foot in diabetes, we conducted an overview of existing systematic reviews to synthesise the available evidence on treatment effects (PROSPERO registration: CRD42016052324). Although the overview identified 19 published reviews [ 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ], it failed to provide reliable numerical summaries of effects because of limitations of the reviews in scope, overlap and quality [ 25 ]. A comprehensive review of RCTs was required to enable us to make the best possible use of the data currently available and re-explore the possibility of performing meta-analyses.
Our aim was to systematically review data from RCTs of interventions used to prevent foot ulcerations in diabetes, and to conduct meta-analyses to obtain pooled estimates of their effects. We included data from RCTs only, as this is the only method of clinical evaluation that controls for known, unknown and unmeasured confounding.
The protocol can be viewed at www.journalslibrary.nihr.ac.uk/programmes/hta/1517101 .
Trials were permitted to include people of any age with a diagnosis of type 1 or type 2 diabetes, with or without a history of ulceration, but free from foot ulceration at trial entry.
Simple interventions (e.g. education aimed at individuals with diabetes or physicians, or the provision of footwear) and complex interventions (where several interventions were provided together) were eligible for inclusion. Standard care or active treatment were eligible as comparators.
We were primarily interested in foot ulcers (incident, primary and recurrent) reported as binary outcomes (present/absent). These could be defined, for example, as ‘a full-thickness skin defect that requires more than 14 days to heal’ [ 26 ] or according to a system of ulcer classification [ 27 ]. Primary outcomes were the absolute numbers of incident primary ulcers and of incident recurrent ulcers.
In reports where foot ulceration was the primary outcome we also sought data on amputation (minor: involving the foot [intrinsic to the foot]; or major: involving the foot and leg); mortality; gangrene; infection; adverse events; harms; time to ulceration; quality of life (measured using the EuroQol five-dimensions questionnaire or the six- or 12-item Short Forms); timing of screening; self-care; hospital admissions; psychological (knowledge/behaviour); and adherence to therapy.
We searched OVID MEDLINE (see electronic supplementary material [ESM] Table 1 ) and OVID EMBASE (from inception to February 2019) and the Cochrane Central Register of Controlled Trials (to October 2018) for eligible RCTs, without language restrictions. ClinicalTrials.gov was searched for ongoing clinical trials (search date: 21 February 2019).
Trial selection and data extraction
One reviewer screened all titles and abstracts and a 10% random sample was checked by a second reviewer. Two reviewers working independently screened full-text articles and extracted data (D. J. Nicholson, and either F. Crawford or A. E. Amanna) about the included populations, including the risk classification, interventions, comparators and outcomes. For each trial we extracted absolute numbers on an intention-to-treat basis, where the numbers randomised to each group were available, and calculated RRs and 95% CIs. Where reports lacked information or clarity, we contacted the trial authors. Non-English language reports were translated.
Risk of bias (quality) assessment
We assessed the quality of trial reporting using the Cochrane Risk of Bias tool [ 28 ]. The five domains we assessed were: random sequence generation, allocation concealment, blinding of assessors to the outcome, incomplete outcome data and selective reporting [ 28 ]. We also noted whether an a priori sample size calculation was reported [ 29 ].
Absolute numbers were extracted and RRs and 95% CIs were calculated. Where it made clinical and statistical sense to pool the data, we undertook meta-analyses with trial data weighted according to the inverse variance method and assessed heterogeneity using the I 2 statistic [ 28 ]. Analyses were conducted using R version 3.4.2 ( https://cran.r-project.org ).
From 10,488 studies, 22 RCTs met our eligibility criteria [ 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. A flow diagram showing the flow of information throughout the process of screening and selecting studies for inclusion in the review is presented in Fig. 1 and the characteristics of the included trials are described in Table 1 . Table 1 also incorporates the results from the risk of bias assessment; only five of the 22 trials [ 36 , 39 , 42 , 46 , 50 ] were judged to be at low risk of bias.
Flow diagram of study selection
Overall, the included trials assessed eight different types of interventions to prevent foot ulceration, which we grouped as follows: (1) education alone (three trials) [ 34 , 35 , 36 ]; (2) dermal infrared thermometry (four trials) [ 37 , 38 , 39 , 40 ]; (3) complex interventions (five trials) [ 41 , 42 , 43 , 44 , 45 ]; (4) custom-made footwear and offloading insoles (six trials) [ 46 , 47 , 48 , 49 , 50 , 51 ]; (5) digital silicone device (one trial) [ 32 ]; (6) antifungal treatment (one trial) [ 30 ]; (7) elastic compression stockings (one trial) [ 31 ]; and (8) podiatric care (one trial) [ 33 ].
Three RCTs evaluated single-session education interventions of varying length and content for people at high risk of foot ulceration [ 34 , 35 , 36 ].
( n = 423) (Fig. 2a ) showed no statistically significant difference in the incidence of foot ulceration at 6 months compared with standard care and advice (RR 1.04 [95% CI 0.54, 1.97]) [ 34 , 35 , 36 ]. The quality of the included trials was variable, with only one trial [ 36 ] judged to be at low risk of bias across all domains. Other sources of potential bias arose from one trial [ 34 ] being stopped early and another [ 35 ] reporting an interim analysis before target recruitment was reached [ 52 ].
Forest plots of foot ulcers in people receiving standard care vs ( a ) education alone, ( b ) dermal infrared thermometry, ( c ) complex interventions and ( d ) custom-made footwear and offloading
Two trials of education interventions reported data on amputation [ 34 , 36 ], mortality [ 34 ], knowledge [ 34 ], behaviour [ 36 ] and/or quality of life [ 36 ]. No amputations were recorded for participants in either arm at 6 months’ follow-up in one trial [ 34 ]. The other trial reported 3/85 amputations in the intervention arm vs 0/85 in the control arm at 6 months, and no difference ( n = 9 in both arms) at 12 months [ 36 ].
One trial [ 34 ] reported that two participants, one in each arm, had died by 6 months. In the same trial, a statistically significant difference in knowledge (as measured by the Patient Interpretation of Neuropathy knowledge score) was observed in the intervention arm [ 34 ].
One trial [ 36 ] reported on quality of life and found no differences between the two arms on the Diabetic Foot Scale, but higher scores for those in the education arm on the Nottingham Assessment of Functional Footcare questionnaire, which assesses behaviour, compared with the control group.
Dermal infrared thermometry
Four RCTs involving 468 participants with diabetes were identified [ 37 , 38 , 39 , 40 ]. In one trial [ 37 ], the numbers of participants randomised to either dermal infrared thermometry or standard care were not known, and so an RR and 95% CI could not be calculated.
A pooled analysis of data from three RCTs ( n = 243) [ 38 , 39 , 40 ] found that dermal infrared thermometry reduced the number of foot ulcers in people with a history of foot ulceration (RR 0.41 [95% CI 0.19, 0.86]) (Fig. 2b ). Outcomes were collected between 6 and 15 months. The quality of these trials was variable, with only one trial [ 39 ] judged to be at low risk of bias across all domains.
Trials of dermal thermometry variously reported on amputation following infection [ 37 ], quality of life (36-item Short Form [SF-36]) [ 37 ], adherence to therapy [ 38 , 39 ] and time to ulceration [ 39 , 40 ].
In one trial, amputations following infections occurred in 0/41 participants in the intervention group vs 2/44 in the comparator group [ 38 ]. In the same trial there was no statistically significant difference in quality of life measured using SF-36 in any category or in the overall score [ 38 ].
Two trials [ 39 , 40 ] found no statistically significant difference between the dermal thermometry group and the comparator group in the time that prescribed footwear and insoles were worn, as measured using a self-report questionnaire containing an ordinal scale of <4 to >12 h/day. The time to ulceration was statistically significantly longer in the dermal thermometry treatment group compared with standard care in one trial [ 39 ] but not in another [ 40 ].
Five RCTs evaluated the effects of complex interventions (i.e. integrated combinations of patient- or physician-level interventions and structural interventions) on the development of a foot ulcer [ 41 , 42 , 43 , 44 , 45 ].
A pooled analysis of data from five RCTs ( n = 2587) showed that complex interventions statistically significantly reduced the number of foot ulcers (RR 0.59 [95% CI 0.38, 0.90]) at 1 or 2 year follow-up (Fig. 2c ), with little evidence of statistical heterogeneity ( I 2 = 10%; Fig. 2c ) despite the variety of interventions tested. However, with the exception of one trial [ 42 ], all had a high risk of bias and the validity of these data may be compromised. One trial gave no information about the participants’ risk category [ 44 ], while three included people with no history of foot ulceration [ 41 , 43 ]. One trial included people who were at low/moderate or high risk of developing a foot ulcer, found that 75% of ulcers occurred in people with higher levels of risk; for the highest risk category (category 4), 2/6 individuals in the intervention group and 2/3 individuals in the comparator group developed foot ulcers [ 41 ].
None of the individual trial results reached statistical significance and only one [ 42 ] reported an a priori sample size calculation; however, one trial [ 45 ] recruited everyone attending the foot care service.
Amputation [ 43 , 45 ], time to ulceration [ 41 ] and/or knowledge [ 43 ] were reported in three trials. In one trial [ 43 ] amputations occurred only in the control arm (2/31 vs 0/31 in the intervention arm), and in a second trial [ 45 ] there were fewer amputations in the intervention group (one major and six minor amputations) compared with the control group (12 major and 13 minor) [ 45 ]. The time to ulceration was shorter in the control group vs the intervention group in one trial, but this did not reach statistical significance [ 41 ].
In one trial participants’ knowledge about foot care, as measured using a diabetes knowledge questionnaire, was statistically significantly better in the intervention group compared with the control group [ 43 ].
Custom-made footwear and offloading insoles
Six RCTs evaluated custom-made footwear and offloading insoles [ 46 , 47 , 48 , 49 , 50 , 51 ].
A pooled estimate of data from six trials showed a beneficial association for custom-made footwear and offloading insoles on reducing the development of foot ulcers (pooled RR 0.53 [95% CI 0.33, 0.85]; Fig. 2d ) for outcomes collected at 12–24 months in 1387 people, of whom 464 had no history of foot ulceration. There was evidence of considerable statistical heterogeneity ( I 2 = 78%), which we explored using baseline risk of ulceration in a subgroup analysis (Fig. 3 ). This pooled analysis of four trials [ 46 , 47 , 50 , 51 ], all of which excluded people with no history of foot ulceration, failed to detect a statistically significant difference (RR 0.71 [95% CI 0.47, 1.06]). The six trials were of variable quality, with only two [ 46 , 50 ] having a low risk of bias across all five domains.
Subgroup analysis. Forest plot of foot ulcers in people with a history of foot ulceration receiving custom-made footwear and offloading vs standard care
Adherence [ 46 , 48 , 49 ] and/or cost [ 48 ] data were reported in four trials. One trial measured adherence using a temperature-based monitor placed inside the shoe, and found that 35/85 participants in the intervention group and 42/86 in the control group adhered to wearing their allocated footwear [ 46 ]. The trial authors conducted a subgroup analysis in participants who wore their allocated footwear, which showed a statistically greater reduction in ulcer recurrence in the intervention group; however, the analysis using data from the entire trial population failed to detect a beneficial association. A second trial of custom-made footwear and offloading insoles measured adherence using a self-reported physical activity questionnaire, and found that footwear and insole use was high in the groups who received cork inserts (83%) and prefabricated insoles (86%) [ 47 ]. A third trial measured participant compliance with footwear using self-reports of the number of hours per day that the shoes were worn. There were no statistically significant differences between each group in the number of people who wore the shoes for less than 4 h per day (23/149 vs 16/150), 4–8 h (77/149 vs 83/150), 8–12 h (38/149 vs 46/150) and 12–16 h (10/149 vs 6/150) [ 49 ].
Cost data collected in one trial published in 2012 found the cost of supplying footwear and insoles to be €675 per person per year [ 48 ].
Digital silicone devices
In one RCT of digital silicone devices [ 32 ], 167 participants with peripheral neuropathy, as defined by a vibration perception threshold of >25 V measured using a biothesiometer, and toe deformities (clawed toes, hallux valgus, interdigital lesions) were randomised to receive a bespoke silicone digital orthotic ( n = 89) or standard care ( n = 78). The number of ulcers was statistically significantly lower in the intervention group (RR 0.07 [95% CI 0.01, 0.55]) at 3 month follow-up. This trial had a low risk of bias in all domains except for allocation concealment, which was unclear.
In a trial of antifungal nail lacquer, participants in the intervention group ( n = 34) received advice to inspect their feet daily and apply ciclopirox 8% to their toenails [ 30 ]. The control group ( n = 36) received advice about daily foot inspections. A history of foot ulcers was reported by 57% of participants. After 12 months there were two ulcerations in each group (RR 1.06 [95% CI 0.19, 5.76]). The risk of bias was unclear in two domains: allocation concealment and blinding of the outcome assessor.
Elastic compression stockings
An RCT of elastic stockings randomly allocated 160 people with no history of foot ulceration to either knee-length elastic stockings worn for 6 h/day or standard care [ 31 ]. There were three ulcers in the intervention group and ten in the control group, a difference that was not statistically significant (RR 0.37 [95% CI 0.11, 1.02]). The trial had a high or unclear risk of bias in the domains of sequence generation, allocation concealment and assessor blinding.
Thirteen limbs were reported as lost during the 48 month trial; 3/74 in the intervention arm and 10/75 in the control arm.
One trial compared free chiropody care ( n = 47) with no chiropody care ( n = 44) for people all at high risk of foot ulceration [ 33 ]. Those receiving free chiropody were recommended to seek care at least once per month. The control group could seek chiropody if they were willing to pay for it, and their standard care included advice on the possible benefits of regular chiropody. There was no statistically significant difference in the number of ulcerations in the two groups (RR 0.67 [95% CI 0.43, 1.05]). This trial had a low risk of bias in all domains except assessor blinding to outcome data, which was unclear.
There were 2/47 amputations in the intervention arm vs 1/44 in the control arm. Deaths were recorded as 2/47 in the intervention arm vs 4/44 in the control arm [ 33 ].
Data for other secondary outcomes of interest, such as gangrene, self-care, hospital admissions, timing of screening and adverse events or harms, were absent from the trial reports.
The search for ongoing trials of foot ulcer prevention in diabetes from the ClinicalTrials.gov website found 24 studies being conducted worldwide. The stated interventions in these studies are: physiotherapy ( n = 1), skin temperature ( n = 6), hygiene ( n = 1), offloading insoles ( n = 10), risk stratification ( n = 2), PET-CT ( n = 1), amniotic tissue ( n = 1) and unclear ( n = 2). The list of these studies can be obtained from the corresponding author.
The purpose of this systematic review was to evaluate the evidence base and obtain summary statistics for preventative interventions for foot ulceration in diabetes to create a cost-effective, evidence-based care pathway. The meta-analyses of dermal infrared thermometry, complex interventions and therapeutic footwear with offloading insoles suggest that these interventions can help prevent foot ulceration in people with diabetes.
The meta-analysis of data from RCTs of dermal infrared thermometry in people with a history of foot ulceration and a moderate to high risk of ulceration indicates that this is a promising intervention deserving of further evaluation in randomised trials with larger participant samples, and we note from our search of the ClinicalTrials.gov trial registry that new trials are currently underway. If foot ulcer prevention can be confirmed in large, well-conducted trials, this form of self-monitoring could relieve pressure on healthcare systems. However, advising individuals to abstain from all weight-bearing activities when foot temperatures rise by more than 4°C may prove challenging, and poor adherence might diminish any benefit in a real-world context outside of a trial setting.
Specialist foot care, of the type evaluated in the included trials of complex interventions, is considered a marker of good-quality diabetes service delivery and it is intuitively correct to suppose it leads to improved outcomes. While a statistically significant reduction in foot ulcers was apparent in our meta-analysis, such an effect was not evident in any single trial. This does support the suggestion of others that very large sample sizes may be needed for trials of this nature [ 53 ]. Surprisingly, there was a low level of statistical heterogeneity in the pooled data, despite quite marked differences in the clinical care provided in the intervention arms of the trials and the participation of people with three different levels of ulcer risk.
Our review did not identify any trials of complex interventions that reflect the composition of multidisciplinary foot services as recommended in clinical guidelines [ 54 , 55 , 56 ]. These influential documents advise the involvement of diabetologists, podiatrists, vascular surgeons, diabetes specialist nurses and orthotists as the core team in a diabetes foot care service, but patient outcomes from such healthcare service arrangements have not been evaluated in RCTs. An evaluation of outcomes from people at different levels of ulceration risk who receive care in specialist foot care settings would be worthwhile.
The true value of therapeutic footwear and offloading insoles in preventing foot ulcers has been obscured by contradictory trial results and poor interpretation of data in systematic reviews; two larger trials involving only those with a history of foot ulcers both failed to detect evidence of effectiveness [ 46 , 47 ], and visual inspection of our analyses of pooled data from all six trials shows greatest beneficial effect in those where the majority of participants were considered to be at high or moderate risk but had not experienced a foot ulcer [ 48 , 49 ], albeit only one reached statistical significance [ 48 ]. Our subgroup analysis of data from four trials of participants with a history of foot ulceration found no statistically significant difference in the number of recurrent ulcers between the custom footwear and control groups.
This observation calls into question the conclusions of other systematic reviews evaluating footwear and insoles in the prevention of foot ulcers [ 6 , 17 , 24 ]. The most recent included randomised and non-randomised data and adopted a consensus approach to the analysis. The reviewers concluded that: ‘The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong, but…is practically non-existent for the prevention of a first foot ulcer and non-plantar foot ulcer’ [ 24 ]. An individual participant data analysis using data from these six trials together with data from the ten ongoing studies of offloading insoles identified by our search of the ClinicalTrials.gov database could permit subgroup analyses to explore the value of footwear and offloading insoles in people with different baseline risks, and potentially resolve these ongoing uncertainties.
The marked reduction in ulcerations reported with the use of a dermal silicone device by individuals at high risk of ulceration is encouraging [ 32 ]. These devices are simple to make at the chair-side and easy for wearers to keep clean. Although they are a type of offloading intervention, we did not include these data in the meta-analysis of footwear and offloading insoles because they differ substantially in that they are only worn around the toes.
Three separate small trials [ 30 , 31 , 33 ] evaluating, respectively, the effects of a daily application of a fungal nail lacquer (ciclopirox 8%) with daily foot inspections, the use of elastic compression stockings and podiatry all failed to show a reduction in foot ulcers, possibly as a result of small sample sizes.
Strengths and limitations of this review
We have comprehensively reviewed a body of evidence from RCTs and made the fullest use of the data currently available to derive best estimates of treatment effects to inform a wider piece of work. In so doing we have highlighted uncertainties, gaps and limitations in the existing evidence base to inform practice, generated new research hypotheses and added value to this area of research.
The weaknesses of this review arise from the potential biases identified in many of the trial reports, especially for complex interventions, which may have produced unreliable results. Previous authors of systematic reviews have cited a lack of similarity between studies [ 13 ], lack of standardisation in terminology, prescription, manufacture and material properties of interventions [ 16 ], heterogeneity in study designs, methodology and participant populations [ 18 ], and differences in participant demographics [ 22 ] as reasons for not conducting meta-analyses, and we are aware of the potential limitations in the pooled analyses that we present here, both in the number and quality of trials. We have tried to produce conservative, less biased summary measures by adopting an intention-to-treat approach and a random-effects model. We acknowledge criticisms about the use of the latter [ 57 ], but believe the insights gleaned and the generation of new research hypotheses justifies our decision to pool data [ 58 ].
Our analyses found evidence of beneficial effects for four types of interventions used to prevent foot ulcers in people with diabetes, but considerable uncertainty remains about what works and who is most likely to benefit. Attention should be given to recommendations for the conduct of trials of interventions for the foot in diabetes, and researchers conducting future trials should endeavour to complete the trial to target recruitment as informed by an a priori sample size calculation [ 29 , 59 ].
A copy of the extracted dataset can be obtained from the corresponding author.
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We thank M. Smith (NHS Fife librarian) and our public partner W. Morrison (Dunfermline, UK) for their help and enthusiasm during the project. We also thank the following for their kind replies to our requests for clarification and additional information about their trials: D. G. Armstrong (University of Southern California, Los Angeles, CA, USA), L. Cisernos (Universidad Federal de Minas Gerais, Brazil), C. Chan (University of Alberta, Edmonton, AB, Canada), J. Everett (University of Calgary, AB, Canada), M. Gershater (Malmö University, Sweden), T. Kelechi (Medical University of South Carolina, Charleston, SC, USA), L. Lavery (University of Texas, Austin, TX, USA), D. Litzelman (Indiana University, Bloomington, IN, USA), S. Morgan (University of Washington, Seattle, WA, USA) and A. Piaggesi (University of Pisa, Italy). We appreciate the help received from two anonymous journal referees for their insightful comments and suggestions for improving our manuscript.
Members of the wider project team who were not directly involved in this research were: K. Gray (R&D Department, NHS Fife), D. Weller (Department of General Practice, University of Edinburgh), J. Brittenden (Institute of Cardiovascular and Medical Sciences, University of Glasgow), J. Lewsey and N. Hawkins (both Health Economics and Health Technology Assessment [HEHTA], Institute of Health and Wellbeing, University of Glasgow).
This systematic review was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (HTA project: 15/171/01) as part of a wider project. The views expressed are those of the authors and not necessarily those of the NIHR or the UK Department of Health and Social Care.
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Fay Crawford, Donald J. Nicolson, Aparna E. Amanna, Angela Martin & Saket Gupta
School of Medicine, University of St Andrews, Fife, UK
NHS Tayside, Dundee, UK
Graham P. Leese
Health Economics and Health Technology Assessment (HEHTA) Institute of Health and Wellbeing College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
The Centre for Clinical Brain Sciences (CCBS) Neuroimaging Sciences, University of Edinburgh, Edinburgh, UK
Francesca M. Chappell
Healthcare Improvement Scotland, Glasgow, UK
Heather H. McIntosh
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Crawford, F., Nicolson, D.J., Amanna, A.E. et al. Preventing foot ulceration in diabetes: systematic review and meta-analyses of RCT data. Diabetologia 63 , 49–64 (2020). https://doi.org/10.1007/s00125-019-05020-7
Received : 03 July 2019
Accepted : 20 August 2019
Published : 27 November 2019
Issue Date : January 2020
DOI : https://doi.org/10.1007/s00125-019-05020-7
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Artificial intelligence based prediction of diabetic foot risk in patients with diabetes: a literature review.
2. materials and methods, 4. discussion, author contributions, institutional review board statement, informed consent statement, data availability statement, conflicts of interest.
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Gosak, L.; Svensek, A.; Lorber, M.; Stiglic, G. Artificial Intelligence Based Prediction of Diabetic Foot Risk in Patients with Diabetes: A Literature Review. Appl. Sci. 2023 , 13 , 2823. https://doi.org/10.3390/app13052823
Gosak L, Svensek A, Lorber M, Stiglic G. Artificial Intelligence Based Prediction of Diabetic Foot Risk in Patients with Diabetes: A Literature Review. Applied Sciences . 2023; 13(5):2823. https://doi.org/10.3390/app13052823
Gosak, Lucija, Adrijana Svensek, Mateja Lorber, and Gregor Stiglic. 2023. "Artificial Intelligence Based Prediction of Diabetic Foot Risk in Patients with Diabetes: A Literature Review" Applied Sciences 13, no. 5: 2823. https://doi.org/10.3390/app13052823
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Systematic review physiotherapeutic interventions in the treatment of patients with diabetic foot ulcers: a systematic literature review ☆.
Diabetic foot ulcers are chronic wounds that are difficult to heal, with a high rate of recurrent hospitalizations. Due to its multifactorial complexity, treatment must be considered as multidisciplinary, with adjuvant therapy required to aid the healing process.
To identify physiotherapeutic interventions for the treatment of diabetic foot ulcers through a systematic literature review.
PubMed, Cochrane Library, SciELO and Web of Science were searched in April 2020.
Study selection or eligibility criteria
The inclusion criteria for this review were: randomised controlled trial published in the last 5 years; written in Portuguese, English or Spanish; subjects aged> 18 years with a diagnosis of diabetic foot ulcers; and physiotherapeutic intervention in combination with multidisciplinary wound management. The methodological quality was assessed using the PEDro scale.
Eight studies were included. Physiotherapists can treat diabetic foot ulcers using therapeutic exercises, electrotherapy, manual therapy and assistive technologies. All physiotherapeutic interventions were adjuvant to standard treatment for wounds provided by other health professionals. The main outcomes were wound size and healing time, with highly favourable results obtained for the experimental groups compared with the control groups.
Therapeutic exercise, electrotherapy, manual therapy and assistive technologies are physiotherapeutic modalities that, when combined with standard treatment, have been shown to be beneficial in the healing of diabetic foot ulcers.
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Negative Pressure Wound Therapy in the Treatment of Diabetic Foot Ulcers: A Systematic Review of the Literature : Journal of Wound Ostomy & Continence Nursing
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Negative Pressure Wound Therapy in the Treatment of Diabetic Foot Ulcers
A systematic review of the literature.
Alan Guffanti, MSN-CRNP, Nurse Practitioner, Advanced Vascular Wound Associates, Darby, Pennsylvania.
Correspondence: Alan Guffanti, MSN-CRNP, 101 Summit Lane, Apt E1, Bala Cynwyd, PA19004 ( [email protected] ).
The author declares no conflicts of interest.
Negative pressure wound therapy (NPWT) is an option for management of complex wounds such as diabetic foot ulcers; therefore, the nursing literature from 2000 to 2010 was reviewed for studies comparing clinical outcomes for diabetic foot ulcers treated with NPWT and those treated with standard moist wound therapy (SMWT). PubMed and OVID databases were explored using the following search terms: vacuum-assisted closure , NPWT, diabetic wounds, and standard most wound therapy. Research studies to judge efficacy were limited to the results from studies of experimental studies with randomized clinical trials on patients with diabetic foot wounds as the inclusion criteria. Four studies were identified that met the established criteria. Despite variations in patient population, methodology, and additional outcome variables studied, NPWT systems were shown to be more effective than SMWT with regard to proportion of healed wounds and rate of wound closure.
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Foot Self-Care Experiences Among Patients With Diabetes: A Systematic Review of Qualitative Studies Several barriers to optimal foot care in persons with diabetes with and without foot ulcers were identified and may be explained and addressed by considering the Health Belief Model.
Purpose Diabetic foot disease is one of the most serious and expensive complications of diabetes. Patient-reported outcome measures (PROMs) analyse patients' perception of their disability, functionality and health. The goal of this work was to conduct a systematic review regarding the specific PROMs related to the evaluation of diabetic foot disease and to extract and analyse the values of ...
The goal of this work was to conduct a systematic review regarding the specific PROMs related to the evaluation of diabetic foot disease and to extract and analyse the values of their measurement properties. Methods: Electronic databases included were PubMed, CINAHL, Scopus, PEDro, Cochrane, SciELO and EMBASE.
We performed the literature search for this systematic review on June 30, 2018 on the basis of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.7 On October 28, 2018, we prospectively registered the systematic review in the PROSPERO database for systematic reviews, which assigned it the number ...
Background Foot-related complications are common in people with diabetes mellitus, however foot care services are underutilized by this population. This research aimed to systematically review the literature to identify patient and practitioner-perceived barriers to accessing foot care services for people with diabetes. Methods PRISMA guidelines were used to inform the data collection and ...
This systematic review aimed to summarise and evaluate the evidence for footwear and insole features that reduce pathological plantar pressures and the occurrence of diabetic neuropathy ulceration at the plantar forefoot in people with diabetic neuropathy.
Aims/hypothesis Foot ulceration is a serious complication for people with diabetes that results in high levels of morbidity for individuals and significant costs for health and social care systems. Nineteen systematic reviews of preventative interventions have been published, but none provides a reliable numerical summary of treatment effects. The aim of this study was to systematically review ...
Existing diabetic foot ulceration risk stratification systems often include variables shown repeatedly in the literature to be strongly predictive of this outcome. Improvement of these risk classification systems though is impaired because of deficiencies noted, including a great lack of standardization in outcome definition and variable ...
Diabetic foot ulcers (DFUs) are a very debilitating complication of diabetes mellitus and contribute to more than 50% of all chronic ulcers in developed countries, with a prevalence of 5-7% in ...
Based on a systematic literature review, we analyzed 14 articles that included the use of artificial intelligence to predict the risk of developing diabetic foot. The articles were highly heterogeneous in terms of data use and showed varying degrees of sensitivity, specificity, and accuracy.
1 Introduction. Diabetic foot (DF) is the most serious and common chronic complication of elderly patients with diabetes and in severe cases, the infection can lead to amputation or even death. It is mainly caused by foot (ankle joint or below) infection, ulcer, and (or) deep tissue destruction related to abnormalities of the distal nerves of the lower extremities and various degrees of ...
This review discusses the evidence on diabetic retinopathy (DR) in patients with diabetic foot ulceration (DFU). A systematic literature review was performed on PubMed, Medline, Springer Nature, and Scopus, following the PRISMA guidelines, using the following terms, individually or in combination: "diabetic foot ulcer" OR "diabetic foot syndrome" OR "DFU" and "diabetic ...
This article derives from a broader systematic literature review on physiotherapeutic interventions in the prevention and treatment of chronic lower limb ulcers, including venous ulcers and diabetic foot ulcers, which is registered on the PROSPERO website (Registration No. CRD42020200042).
ist wound therapy (SMWT). PubMed and OVID databases were explored using the following search terms: vacuum-assisted closure, NPWT, diabetic wounds, and standard most wound therapy. Research studies to judge efficacy were limited to the results from studies of experimental studies with randomized clinical trials on patients with diabetic foot wounds as the inclusion criteria. Four studies were ...