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      Footwear and insole design features that reduce neuropathic plantar forefoot ulcer risk in people with diabetes: a systematic literature review

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          Abstract

          Background

          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.

          Methods

          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.

          Results

          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.

          Conclusion

          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.

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          Most cited references59

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          Diabetic foot ulcers.

          Ulceration of the foot in diabetes is common and disabling and frequently leads to amputation of the leg. Mortality is high and healed ulcers often recur. The pathogenesis of foot ulceration is complex, clinical presentation variable, and management requires early expert assessment. Interventions should be directed at infection, peripheral ischaemia, and abnormal pressure loading caused by peripheral neuropathy and limited joint mobility. Despite treatment, ulcers readily become chronic wounds. Diabetic foot ulcers have been neglected in health-care research and planning, and clinical practice is based more on opinion than scientific fact. Furthermore, the pathological processes are poorly understood and poorly taught and communication between the many specialties involved is disjointed and insensitive to the needs of patients.
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            Revision of a method quality rating scale for single-case experimental designs and n-of-1 trials: the 15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale.

            Recent literature suggests a revival of interest in single-case methodology (e.g., the randomised n-of-1 trial is now considered Level 1 evidence for treatment decision purposes by the Oxford Centre for Evidence-Based Medicine). Consequently, the availability of tools to critically appraise single-case reports is of great importance. We report on a major revision of our method quality instrument, the Single-Case Experimental Design Scale. Three changes resulted in a radically revised instrument, now entitled the Risk of Bias in N-of-1 Trials (RoBiNT) Scale: (i) item content was revised and increased to 15 items, (ii) two subscales were developed for internal validity (IV; 7 items) and external validity and interpretation (EVI; 8 items), and (iii) the scoring system was changed from a 2-point to 3-point scale to accommodate currently accepted standards. Psychometric evaluation indicated that the RoBiNT Scale showed evidence of construct (discriminative) validity. Inter-rater reliability was excellent, for pairs of both experienced and trained novice raters. Intraclass correlation coefficients of summary scores for individual (experienced) raters: ICC(TotalScore) = .90, ICC(IVSubscale) = .88, ICC(EVISubscale) = .87; individual (novice) raters: ICC(TotalScore)= .88, ICC(IVSubscale) = .87, ICC(EVISubscale) = .93; consensus ratings between experienced and novice raters (ICC(TotalScore) = .95, ICC(IVSubscale) = .93, ICC(EVISubscale) = .93. The RoBiNT Scale thus shows sound psychometric properties and provides a comprehensive yet efficient examination of important features of single-case methodology.
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              Risk factors for plantar foot ulcer recurrence in neuropathic diabetic patients.

              Recurrence of plantar foot ulcers is a common and major problem in diabetes but not well understood. Foot biomechanics and patient behavior may be important. The aim was to identify risk factors for ulcer recurrence and to establish targets for ulcer prevention. As part of a footwear trial, 171 neuropathic diabetic patients with a recently healed plantar foot ulcer and custom-made footwear were followed for 18 months or until ulceration. Demographic data, disease-related parameters, presence of minor lesions, barefoot and in-shoe plantar peak pressures, footwear adherence, and daily stride count were entered in a multivariate multilevel logistic regression model of plantar foot ulcer recurrence. A total of 71 patients had a recurrent ulcer. Significant independent predictors were presence of minor lesions (odds ratio 9.06 [95% CI 2.98-27.57]), day-to-day variation in stride count (0.93 [0.89-0.99]), and cumulative duration of past foot ulcers (1.03 [1.00-1.06]). Significant independent predictors for those 41 recurrences suggested to be the result of unrecognized repetitive trauma were presence of minor lesions (10.95 [5.01-23.96]), in-shoe peak pressure 80% (0.43 [0.20-0.94]), barefoot peak pressure (1.11 [1.00-1.22]), and day-to-day variation in stride count (0.91 [0.86-0.96]). The presence of a minor lesion was clearly the strongest predictor, while recommended use of adequately offloading footwear was a strong protector against ulcer recurrence from unrecognized repetitive trauma. These outcomes define clear targets for diabetic foot screening and ulcer prevention. © 2014 by the American Diabetes Association.
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                Author and article information

                Contributors
                s.ahmed.13@student.scu.edu.au , sahmed50@gmail.com
                alex.barwick@scu.edu.au
                paul.butterworth@scu.edu.au
                susan.nancarrow@scu.edu.au
                Journal
                J Foot Ankle Res
                J Foot Ankle Res
                Journal of Foot and Ankle Research
                BioMed Central (London )
                1757-1146
                4 June 2020
                4 June 2020
                2020
                : 13
                : 30
                Affiliations
                GRID grid.1031.3, ISNI 0000000121532610, School of Health and Human Sciences, , Southern Cross University, ; Billinga, Queensland 4225 Australia
                Author information
                http://orcid.org/0000-0002-9049-6825
                Article
                400
                10.1186/s13047-020-00400-4
                7271493
                32498719
                c25b6380-1a5c-42c9-be9c-790f08729d6a
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 10 February 2020
                : 22 May 2020
                Categories
                Review
                Custom metadata
                © The Author(s) 2020

                Orthopedics
                diabetic foot,footwear,insoles,plantar pressure
                Orthopedics
                diabetic foot, footwear, insoles, plantar pressure

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