INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol

Collings, Richard; Freeman, Jennifer; Latour, Jos M.; Vickery, Patricia Jane; Glasser, Sam; Lepesis, Vasileios; Enki, Doyo; Paton, Joanne

doi:10.1136/bmjopen-2019-029185

Cited by 5 publications

(2 citation statements)

References 39 publications

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“…A participant and assessor-blinded, randomized, multicentre, parallel-group feasibility trial with an embedded qualitative study was conducted. The methodology of the fRCT is described brie y below, with more detail in the published protocol (18).…”

Section: Methodsmentioning

confidence: 99%

Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study

Collings

Freeman

Latour

et al. 2021

Preprint

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Background: Therapeutic footwear and insoles are preventative strategies to reduce elevated plantar pressures associated with diabetic foot ulcer risk. An insole intervention appropriate for chairside delivery optimizing plantar foot pressure reduction in people with diabetes has been developed. Aim: To explore the feasibility and acceptability of testing an optimized insole compared with an active control insole to reduce plantar pressures for people with diabetic peripheral neuropathy.Methods: A double-blinded multicentre feasibility RCT with an embedded qualitative study. In addition to usual care, participants were randomized to either an optimized insole group (Intervention) or a standard cushioned insole group (Active control). Participants were assessed at baseline, 3, 6 and 12 months with clinical outcome of mean peak plantar pressure (MPPP) reduction. An embedded qualitative study involved semi-structured interviews with 12 study participants and three podiatrists to explore their experiences of the intervention and trial procedures. Data were analyzed using descriptive statistics (quantitative data) and thematic analysis (qualitative data).Results: Screened were142 patients from which 61 were recruited; 30 participants were randomized to the Intervention group and 31 to the Active control group. Forty-two participants completed the study. At 12-months, 69% of the patient-reported questionnaires were returned and 68% of the clinical outcomes were collected. Mean difference in MPPP between the Intervention and Active control groups for all regions-of-interest combined favoured the Intervention, with increases from 87kPa at post-randomization to 255kPa at 12-months. Thematic analysis revealed three themes; accepting the study, behaviour and support during study procedures, and impact from study participation. Conclusion: The results of the feasibility RCT suggest that the optimized insole holds promise as an intervention, and that a full RCT to evaluate the clinical and cost-effectiveness of this intervention is feasible and warranted for people with diabetic peripheral neuropathy. Trial registration: International Standard Randomized Controlled Trial Number: ISRCTN16011830. Registered 9th October 2017, https://www.isrctn.com/ISRCTN16011830

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Section: Methodsmentioning

confidence: 99%

Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study

Collings

Freeman

Latour

et al. 2021

Preprint

Self Cite

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“…The insole has functions such as cushioning, resilience, and stiffness. The EVA has been used as an insole material in different plantar regions (forefoot, midfoot, and rearfoot) [36][37][38]. Single EVA as a foam-based material was excellent for energy absorption to support the rearfoot pressure reduction [39].…”

Section: Introductionmentioning

confidence: 99%

A Review of the Plantar Pressure Distribution Effects from Insole Materials and at Different Walking Speeds

et al. 2021

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Among people with diabetes mellitus (DM), the two common strategies for decreasing peak plantar pressure (PPP) to reduce diabetic foot ulcers (DFUs) risks are to modify walking speeds and to change insole materials. This study reviewed the PPP reduction based on various walking speeds and insole materials. The articles were retrieved from four major scientific databases and manual search. We identified 1585 articles, of which 27 articles were selected for full-text analysis. We found that in faster walking speeds, the forefoot PPP was higher (308 kPa) than midfoot (150 kPa) and rearfoot (251 kPa) PPP. The appropriate walking speed for reducing the forefoot PPP was about 6 km/h for non-DM and 4 km/h for DM people. The forefoot PPP in DM people was 185% higher than that of non-DM people. Ethylene–vinyl acetate (EVA) insole material was the most popular material used by experts (26%) in the forefoot and reduced 37% of PPP. In conclusion, the suitable walking speed for DM was slower than for non-DM people, and EVA was the most common insole material used to decrease the PPP under the forefoot. The clinicians might recommend DM people to walk at 4 km/h and wear EVA insole material to minimize the DFUs.

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Factors associated with changes in plantar pressure of people with peripheral diabetic neuropathy

Jorgetto

Oggiam

Gamba

et al. 2022

J Diabetes Metab Disord

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INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol

Cited by 5 publications

References 39 publications

Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study

Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study

A Review of the Plantar Pressure Distribution Effects from Insole Materials and at Different Walking Speeds

Factors associated with changes in plantar pressure of people with peripheral diabetic neuropathy

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