Prevention of foot ulcer recurrence in diabetes patients using plantar pressure biofeedback

Not Applicable

Completed

• Conditions: Topic: Diabetes Research Network; Subtopic: Both; Disease: Neuropathy, Diabetic foot; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN05585501
• Lead Sponsor: Manchester Metropolitan University (UK)

Brief Summary

2018 results presented at the 54th EASD Annual Meeting of the European Association for the Study of Diabetes in https://link.springer.com/content/pdf/10.1007%2Fs00125-018-4693-0.pdf [abstract 7] (added 24/06/2019) 2019 results in https://pubmed.ncbi.nlm.nih.gov/33323253/ (added 20/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-04
• Study Completion: 2017-10-31
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Diagnosed with Type 1 or 2 diabetes
2. A history of previous ulceration on the weight-bearing surface of the foot
3. Presence of neuropathy (defined by any loss of sensation)
4. Ability to walk independently for approx. 100 metres (i.e., without use of wheelchair, walking stick or personal assistance)
5. Aged >18 years
6. Able to understand all of the study requirements and have a life expectancy greater than the study duration
Target Gender: Male & Female

Exclusion Criteria

1. Active foot ulcer
2. In-shoe orthotics consisting of non-compressible materials
3. Presence of severe ischaemia for either foot defined by complete absence of foot pulses and ankle-brachial pressure index <0.6
4. Lower limb amputation affecting the ability to walk approx. 100 metres
5. Dementia, uncorrected visual or psychological impairment
6. Psychiatric illnesses or social situations that would limit compliance with the study
7. Inner ear pathology, or other serious underlying balance dysfunction
8. Significant cardiopulmonary or other systemic disease limiting the patient's ability to walk approx. 100 metres unaided
9. Current participation in another clinical investigation of a medical device or a drug, or participation in such a study within 30 days prior to study enrolment
10. Body Mass Index (BMI) >40

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Foot ulceration. The feet will be checked for ulceration every month for 18 months.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration