Revascularisation, microcirculation and diabetic foot disease
Research type
Research Study
Full title
What is the relationship of revascularisation and improvement in microcirculation to wound healing and peripheral neuropathy in diabetic foot disease? An observational cohort study.
IRAS ID
143758
Contact name
Alok Tiwari
Contact email
Sponsor organisation
Head of Research and Development Governance Queen Elizabeth Hospital Birmingham
Research summary
Patients who have both diabetes mellitus (DM) and disease of the arteries in the legs are known to have poor outcomes if they develop foot ulcers. For these patients more information is required to aid clinicians with deciding when to intervene and what the indications for intervening are. Conventional measures used in the outpatient setting to assess vascular compromise are known to be less effective in patients with DM.
By closely following patients who have an active ulcer after they undergo either lower limb bypass surgery or lower limb angioplasty we aim to gain more information about the vascular factors that change after these procedures and how they are related to healing of the ulcer. We will be using laser Doppler fluxmetry (LDF) to examine the function of the small vessels in the foot and how this changes in the time leading up to healing.
Our participants will all have tissue loss. The main groups will be those undergoing bypass compared to those undergoing angioplasty. These two groups will then be further divided into those with and without DM. We also intend to recruit a third group of patients with DM and tissue loss but no significant peripheral vascular disease contributing to their condition.
Participants in the study will undergo LDF investigation of the microcirculation and assessment of peripheral neuropathy. This will be repeated at regular intervals until the ulcer has healed, or another endpoint is reached. The study sites will be hospitals in the West Midlands.
By gaining information about the condition of the microcirculation that is required for ulcer healing the aim is to be able to give guidance on the level of microcirculatory dysfunction that would be an indication for intervention even if an ulcer has not yet developed.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
14/WM/1010
Date of REC Opinion
25 Jun 2014
REC opinion
Further Information Favourable Opinion