DFURRA
Research type
Research Study
Full title
Risk Acceptance for Revascularisation Procedures for Diabetes-related Foot Ulcers
IRAS ID
337412
Contact name
Robert Hinchliffe
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
This study investigates the levels of risk acceptance of patients and clinicians towards revascularisation procedures for diabetes-related foot ulceration (DFU).
DFU is defined by foot ulceration resulting from and complicated by peripheral neuropathy and/or peripheral arterial disease in patients with diabetes mellitus. Ulcers may be managed conservatively with regular wound care, medical optimization of risk factors, and antibiotic therapy for infections. However, conservative management alone is associated with poor rates of ulcer healing and may lead to eventual limb loss. Revascularisation is therefore recommended for most patients with poorly healing DFU and peripheral arterial disease. The goal of revascularisation is to improve blood flow through the affected limb, so as to promote wound healing and limb salvage. This is achieved with either endovascular or open surgery, or a combination of both. However, such procedures carry risks of complications such as treatment failure (where the operation fails to re-establish good blood flow), need for re-operation, amputation, and even mortality.
This study aims to investigate the level of risk that patients and healthcare professionals are willing to accept with regards to revascularisation procedures for DFU. Such knowledge will allow for greater understanding of factors associated with higher risk acceptance levels, and comparison of risk acceptance levels between clinicians and patients. The ultimate goal is to improve the shared decision making process between clinicians and patients with DFU.
Eligible participants are patients with ongoing or a history of DFU, and clinicians with experience in managing DFU. Participants will be interviewed according to a standardized questionnaire for patients and clinicians respectively, via Microsoft Teams or over the phone. A modified stable gamble approach will be used to assess revascularisation risk acceptance levels.REC name
London - London Bridge Research Ethics Committee
REC reference
25/PR/0238
Date of REC Opinion
20 Jun 2025
REC opinion
Further Information Favourable Opinion