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

Not Applicable

Completed

• Conditions: Specialty: Musculoskeletal disorders, Primary sub-specialty: Non-pharmacological Interventions; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus, Neurological/ Other disorders of the nervous system; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN16011830
• Lead Sponsor: Plymouth University

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30904880 protocol (added 09/04/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36737812/ (added 06/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-09
• Study Completion: 2020-02-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. Confirmed diagnosis of type 1 or 2 diabetes as confirmed by medical records
2. Aged over 18 years
3. Identified clinical need for offloading insoles by podiatrist
4. Neuropathic (sensory peripheral diabetic neuropathy)
5. Palpable pedal foot pulses
6. Able and willing to comply with all trial requirement

Exclusion Criteria

1. Any other significant disease or disorder which, in the opinion of the PI, may put the participant at risk of health deterioration, such as falls, because of their involvement in the trial
2. Non healing foot ulcer at another site that requires targeted off-loading
3. Unable to walk five metres with/without walking aid
4. Unable to stand on either leg independently for 10 seconds (+/- chair aid to assist in balance)
5. Lacking capacity or unwilling to give consent
6. Already wearing existing insoles that are clinically appropriate
7. Peripheral vascular disease (non-re-constructible vascular disease as determined by arterial duplex)
8. Unwilling to wear therapeutic footwear
9. Gross foot deformity e.g. charcot foot or fixed rear foot deformity
10. Unable to provide adequate consent to undertake the trial procedures
11. Major amputation of part of the foot

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. To assess the feasibility and acceptability of the trial procedures through the 12 month trial period is measured using:<br> 1.1. Numbers of eligible participants from the target population<br> 1.2. Recruitment and retention rates of eligible participants through the trial<br> 1.3. Willingness of participants to be randomised<br> 1.4. Assess the pragmatism of delivering the insole intervention in the proposed settings by qualitative interviews<br> 1.5. Variation and fidelity in the delivery of the intervention in each. A fidelity checklist will evaluate the adherence by the treating podiatrists to the standardised protocol of intervention delivery.<br> 1.6. Completeness of data sets/outcome measures<br> 1.7. Success of the blinding by using the Bang Index<br>