Wound Healing, Management and Early Prosthetic Rehabilitation
Research type
Research Study
Full title
Wound Healing, Management and Early Prosthetic Rehabilitation: A Pilot Study Investigating the Efficacy of Measures of Primary Surgical Site Healing Assessment in a Group of Diabetic Transtibial Elective Amputees Subjected to Six Standard Treatment Pathways.
IRAS ID
354197
Contact name
Arjan Buis
Contact email
Sponsor organisation
University of Strathclyde
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
The benefits of prosthetic rehabilitation after lower limb amputation are well-documented. Prosthetics help mitigate negative health impacts, reduce healthcare costs, and impact positively on survival. Access to prostheses is influenced in part by surgical site wound healing. Current assessments are limited, influenced by clinician judgment and timing inconsistencies. Debates persist on optimal treatment paths for promoting wound healing. Rigid dressings are believed to speed up healing over soft dressings, but supporting evidence is weak. Similarly, in below-knee socket casting analysis, hands-off (ICECast pressure casting) methods showed less intra-cast variability than hands-on (traditional Plaster of Paris) methods, but validation is needed.
The proposed pilot study aims to test outcome measures to enhance the holistic assessment of surgical site healing and evaluate the impact of six common treatment pathways post transtibial amputation (Össur rigid removable dressing, ScotchcastTM/Plaster of Paris rigid dressing, or standard soft post-operative dressing, followed by hands-on or hands-off first prosthetic casting). By following a minimum of 6 participants through their entire pathway from pre-operative to post-operative care, the study will span up to six months post-operatively, with participants expected to be first involved one to three days pre-operatively. Objective outcome measures include oxygen saturation, temperature, swelling, and levels of biomarkers secreted by healing cells.
Most amputations in Scotland are performed for chronic limb threatening ischaemia and/or complications of diabetes mellitus. Data will be collected post-amputation at the Queen Elizabeth University Hospital and at the West of Scotland Mobility and Rehabilitation Centre, both part of the Greater Glasgow and Clyde NHS Health Board. Data analysis will be conducted at the Department for Biomedical Engineering, University of Strathclyde.REC name
West of Scotland REC 5
REC reference
25/WS/0091
Date of REC Opinion
29 Jul 2025
REC opinion
Further Information Favourable Opinion