The Effects of Plastazote?? and Aliplast??/Plastazote?? Orthoses on Plantar Pressures in Elderly Persons With Diabetic Neuropathy

Mohamed, Olfat; Cerny, Kay; Rojek, Loren; Herbert, Krista; Turner, Rebecca; Waistell, Sean

doi:10.1097/00008526-200404000-00005

Cited by 21 publications

(27 citation statements)

References 18 publications

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“…Reductions in peak pressure observed at insole issue in our study (31-37%) are, however, comparable to peak pressure reductions demonstrated by other non-randomised studies (32%) [22,23]. At six month follow-up, peak pressure reductions observed in our trial (Prefabricated 31%, Custom-made functional 37%) appear better than findings presented elsewhere.…”

Section: Discussionsupporting

confidence: 77%

A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant‐blinded randomised controlled trial

Paton

Stenhouse

Bruce

et al. 2012

Journal of Foot and Ankle Research

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BackgroundNeuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues is reduced. Insole therapy is one practical method commonly used to reduce plantar loads and ulceration risk. The type of insole best suited to achieve this is unknown. This trial compared custom-made functional insoles with prefabricated insoles to reduce risk factors for ulceration of neuropathic diabetic feet.MethodA participant-blinded randomised controlled trial recruited 119 neuropathic participants with diabetes who were randomly allocated to custom-made functional or prefabricated insoles. Data were collected at issue and six month follow-up using the F-scan in-shoe pressure measurement system. Primary outcomes were: peak pressure, forefoot pressure time integral, total contact area, forefoot rate of load, duration of load as a percentage of stance. Secondary outcomes were patient perceived foot health (Bristol Foot Score), quality of life (Audit of Diabetes Dependent Quality of Life). We also assessed cost of supply and fitting. Analysis was by intention-to-treat.ResultsThere were no differences between insoles in peak pressure, or three of the other four kinetic measures. The custom-made functional insole was slightly more effective than the prefabricated insole in reducing forefoot pressure time integral at issue (27% vs. 22%), remained more effective at six month follow-up (30% vs. 24%, p=0.001), but was more expensive (UK £656 vs. £554, p<0.001). Full compliance (minimum wear 7 hours a day 7 days per week) was reported by 40% of participants and 76% of participants reported a minimum wear of 5 hours a day 5 days per week. There was no difference in patient perception between insoles.ConclusionThe custom-made insoles are more expensive than prefabricated insoles evaluated in this trial and no better in reducing peak pressure. We recommend that where clinically appropriate, the more cost effective prefabricated insole should be considered for use by patients with diabetes and neuropathy.Trial registrationClinical trials.gov (NCT00999635). Note: this trial was registered on completion.

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Section: Discussionsupporting

confidence: 77%

A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant‐blinded randomised controlled trial

Paton

Stenhouse

Bruce

et al. 2012

Journal of Foot and Ankle Research

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“…Fifty‐four studies met the inclusion criteria. Study designs included: n = 13 RCT’s, 23,25,31,38,42,49,55,56,61,62,70,73,77 n = 37 cohort studies, 20‐22,24,26‐30,32‐37,39‐41,43,45,47‐49,51‐54,57‐60,64,66‐68,71,72 n = 2 case‐control studies, 44,63 n = 1 nonintervention case series study 46 and n = 1 nonrandomized cross‐sectional over trial 65 . Four authors reported results of the same study in different papers 21,22,39,40,45,47,49,50 and therefore results from these studies were described, but only one set of each results was used within any meta‐analysis.…”

Section: Resultsmentioning

confidence: 99%

“…Four authors reported results of the same study in different papers 21,22,39,40,45,47,49,50 and therefore results from these studies were described, but only one set of each results was used within any meta‐analysis. Studies were published between 1975 and 2019, undertaken in US (n = 17), 20,24,33,35,37,42,45‐48,51,54,55,58,59,62,65 UK (n = 10), 23,30,32,49,50,67,68,71,73,77 Netherlands (n = 7), 21,22,26,27,36,52,64 Germany (n = 4), 28,29,44,57 Italy (n = 2), 56,61 Australia (n = 3), 25,31,53 Taiwan (n = 3), 39,40,43 Spain (n = 2), 34,70 Thailand (n = 2), 66,72 Austria (n = 1), 41 Sweden (n = 1), 38 Hong Kong (n = 1) 60 and India (n = 1) 63 . The number of participants recruited to treatment groups ranged from seven to 298.…”

Section: Resultsmentioning

confidence: 99%

“…Two features of insole profile were described in the majority of studies; arch profile and rocker profile. In total, 69% (n = 37) of studies 20‐29,34,36‐38,41,43‐46,48‐51,53‐56,58‐64,66,68,73 reported using an arch profile as a feature of an insole (Appendix ) and 37% (n = 20) of studies 26,28‐30,34,35,38,40,48‐50,52,54‐56,61,64,65,67,70 reported rockers as an added feature of the shoe outsole (Appendix ). One study 39 lacked enough clarity in the description of the intervention to determine whether a rocker feature was used in the diabetic footwear.…”

Section: Resultsmentioning

confidence: 99%

“…Sixty‐nine per cent (n = 37) of studies 21‐23,25‐30,34,36,41‐44,46,48‐50,52‐56,58,60‐66,68,70‐73 used a combination of materials with diverse properties to manufacture the insoles or shoe outsole (Appendix ). Thirty per cent (n = 16) of studies 20,23,27,29,34,35,46,48‐50,52,54,55,58,60‐62,68 used dual density constructs, thirty‐nine per cent (n = 21) of studies 21,22,25,26,28,30,36,41‐44,52,53,56,63‐66,70,72,73 used tri or multi‐density/layers. Five studies examined the influence of material on reducing MPP.…”

Section: Resultsmentioning

confidence: 99%

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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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The use of textiles and materials for orthopedic footwear insoles

Yick

Tse²

2021

Handbook of Footwear Design and Manufacture

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The Effects of Plastazote?? and Aliplast??/Plastazote?? Orthoses on Plantar Pressures in Elderly Persons With Diabetic Neuropathy

Cited by 21 publications

References 18 publications

A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant‐blinded randomised controlled trial

A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant‐blinded randomised controlled trial

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

The use of textiles and materials for orthopedic footwear insoles

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