Evaluation of orthotic insoles for people with diabetes who are at‐risk of first ulceration

Martinez-Santos, Ana; Preece, Stephen; Nester, Christopher

doi:10.1186/s13047-019-0344-z

Cited by 32 publications

(79 citation statements)

References 57 publications

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“…The support is covered by the insole top layer. The height of the support should be 9‐10 mm The location of the support should be 6‐11 mm proximal to the metatarsal head, in static position . This means that with a support with an apex 10 mm from its distal edge, the distal edge is 6‐11 mm proximal to the center of the metatarsal head .…”

Section: Resultsmentioning

confidence: 99%

“…A metatarsal support significantly improves peak pressure reduction at the metatarsal heads Use a transmetatarsal bar that covers all metatarsal heads as support .…”

Section: Resultsmentioning

confidence: 99%

“…The base of the insole in a fully custom-made shoe should be of 5-mm-thick micro cork (shore 55) with on top 5-mm-thick Ethylene Vinyl Acetate (EVA) (shore [35][36][37][38][39][40]. With prefabricated shoes the base should consist of 6-mm-thick EVA (shore [35][36][37][38][39][40]. The use of materials with proven similar properties in mainly compressibility and durability is also possible.…”

Section: Insole Basementioning

confidence: 99%

“…A metatarsal support significantly improves peak pressure reduction at the metatarsal heads. 10,19,[27][28][29][30][31][32][33][34][35][36][37][38] • Use a transmetatarsal bar that covers all metatarsal heads as support. 30 A metatarsal pad or dome can be used if only one metatarsal region shows (signs of) high pressure, or is a previous ulcer site.…”

Section: Metatarsal Supportmentioning

confidence: 99%

“…29 • The location of the support should be 6-11 mm proximal to the metatarsal head, in static position. 32,37,38 This means that with a support with an apex 10 mm from its distal edge, the distal edge is 6-11 mm proximal to the center of the metatarsal head. 31 Thus, the apex of the metatarsal support is 16-21 mm from the center of the metatarsal head.…”

Section: Metatarsal Supportmentioning

confidence: 99%

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State of the art design protocol for custom made footwear for people with diabetes and peripheral neuropathy

Bus

Zwaferink

Dahmen

et al. 2019

Diabetes Metabolism Res

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Supported by evidence‐based guidelines, custom‐made footwear is often prescribed to people with diabetes who are at risk for ulceration. However, these guidelines do not specify the footwear design features, despite available scientific evidence for these features. We aimed to develop a design protocol to support custom‐made footwear prescription for people with diabetes and peripheral neuropathy. The population of interest was people with diabetes who are at moderate‐to‐high risk of developing a foot ulcer, for whom custom‐made footwear (shoes and/or insoles) can be prescribed. A group of experts from rehabilitation medicine, orthopaedic shoe technology (pedorthics) and diabetic foot research, reviewed the scientific literature and met during 12 face‐to‐face meetings to develop a footwear design algorithm and evidence‐based pressure‐relief algorithm as parts of the protocol. Consensus was reached where evidence was not available. Fourteen domains of foot pathology in combination with loss of protective sensation were specified for the footwear design algorithm and for each domain shoe‐specific and insole (orthosis)‐specific features were defined. Most insole‐related features and some shoe‐related features were evidence based, whereas most shoe‐related features were consensus based. The pressure‐relief algorithm was evidence based using recent footwear trial data and specifically targeted patients with a healed plantar foot ulcer. These footwear design and pressure‐relief algorithms are the first of their kind and should facilitate more uniform decision making in the prescription and manufacturing of adequate shoes for moderate‐to‐high‐risk patients, reducing variation in footwear provision and improving clinical outcome in the prevention of diabetic foot ulcers.

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Section: Resultsmentioning

confidence: 99%

“…A metatarsal support significantly improves peak pressure reduction at the metatarsal heads Use a transmetatarsal bar that covers all metatarsal heads as support .…”

Section: Resultsmentioning

confidence: 99%

Section: Insole Basementioning

confidence: 99%

Section: Metatarsal Supportmentioning

confidence: 99%

Section: Metatarsal Supportmentioning

confidence: 99%

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State of the art design protocol for custom made footwear for people with diabetes and peripheral neuropathy

Bus

Zwaferink

Dahmen

et al. 2019

Diabetes Metabolism Res

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Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta‐analysis

Netten

Raspovic

Lavery

et al. 2023

Diabetes Metabolism Res

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AimsPrevention of foot ulcers in persons with diabetes is important to help reduce the substantial burden on both individual and health resources. A comprehensive analysis of reported interventions is needed to better inform healthcare professionals about effective prevention. The aim of this systematic review and meta‐analysis is to assess the effectiveness of interventions to prevent foot ulcers in persons with diabetes who are at risk thereof.Materials and MethodsWe searched the available scientific literature in PubMed, EMBASE, CINAHL, Cochrane databases and trial registries for original research studies on preventative interventions. Both controlled and non‐controlled studies were eligible for selection. Two independent reviewers assessed risk of bias of controlled studies and extracted data. A meta‐analysis (using Mantel‐Haenszel's statistical method and random effect models) was done when >1 RCT was available that met our criteria. Evidence statements, including the certainty of evidence, were formulated according to GRADE.ResultsFrom the 19,349 records screened, 40 controlled studies (of which 33 were Randomised Controlled Trials [RCTs]) and 103 non‐controlled studies were included. We found moderate certainty evidence that temperature monitoring (5 RCTs; risk ratio [RR]: 0.51; 95% CI: 0.31–0.84) and pressure‐optimised therapeutic footwear or insoles (2 RCTs; RR: 0.62; 95% CI: 0.26–1.47) likely reduce the risk of plantar foot ulcer recurrence in people with diabetes at high risk. Further, we found low certainty evidence that structured education (5 RCTs; RR: 0.66; 95% CI: 0.37–1.19), therapeutic footwear (3 RCTs; RR: 0.53; 95% CI: 0.24–1.17), flexor tenotomy (1 RCT, 7 non‐controlled studies, no meta‐analysis), and integrated care (3 RCTs; RR: 0.78; 95% CI: 0.58–1.06) may reduce the risk of foot ulceration in people with diabetes at risk for foot ulceration.ConclusionsVarious interventions for persons with diabetes at risk for foot ulceration with evidence of effectiveness are available, including temperature monitoring (pressure‐optimised) therapeutic footwear, structured education, flexor tenotomy, and integrated foot care. With hardly any new intervention studies published in recent years, more effort to produce high‐quality RCTs is urgently needed to further improve the evidence base. This is especially relevant for educational and psychological interventions, for integrated care approaches for persons at high risk of ulceration, and for interventions specifically targeting persons at low‐to‐moderate risk of ulceration.

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Footwear and insole design features for offloading the diabetic at risk foot—A systematic review and meta‐analyses

Collings

Freeman

Latour

et al. 2020

Endocrino Diabet & Metabol

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The aim of this systematic review was to identify the best footwear and insole design features for offloading the plantar surface of the foot to prevent foot ulceration in people with diabetic peripheral neuropathy. We searched multiple databases for published and unpublished studies reporting offloading footwear and insoles for people with diabetic neuropathy and nonulcerated feet. Primary outcome was foot ulcer incidence; other outcome measures considered were any standardized kinetic or kinematic measure indicating loading or offloading the plantar foot. Fifty‐four studies, including randomized controlled studies, cohort studies, case‐series, and a case‐controlled and cross‐sectional study were included. Three meta‐analyses were conducted and random‐effects modelling found peak plantar pressure reduction of arch profile (37 kPa (MD, −37.5; 95% CI, −72.29 to −3.61; P < .03), metatarsal addition (35.96 kPa (MD, −35.96; 95% CI, −57.33 to −14.60; P < .001) and pressure informed design 75.4 kPa (MD, −75.4 kPa; 95% CI, −127.4 to −23.44 kPa; P < .004).The remaining data were presented in a narrative form due to heterogeneity. This review highlights the difficulty in differentiating the effect of different insole and footwear features in offloading the neuropathic diabetic foot. However, arch profiles, metatarsal additions and apertures are effective in reducing plantar pressure. The use of pressure analysis to enhance the effectiveness of the design of footwear and insoles, particularly through modification, is recommended.

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Evaluation of orthotic insoles for people with diabetes who are at‐risk of first ulceration

Cited by 32 publications

References 57 publications

State of the art design protocol for custom made footwear for people with diabetes and peripheral neuropathy

State of the art design protocol for custom made footwear for people with diabetes and peripheral neuropathy

Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta‐analysis

Footwear and insole design features for offloading the diabetic at risk foot—A systematic review and meta‐analyses

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