VEWS index relationship to ischaemic ulcer outcome. V2
Research type
Research Study
Full title
Single centre, pilot study to evaluate the relationship of the VEWS® (Vascular Early Warning System) Index to wound healing outcome in patients with ischaemic foot ulcers
IRAS ID
135902
Contact name
Richard Leigh
Contact email
Sponsor organisation
Dialog Devices
Research summary
A significant number of patients with poor blood flow to their lower legs (peripheral vascular disease) will go on to develop symptoms including ischaemic foot ulcers. These ulcers may not heal without arterial surgery to improve blood flow and can result in lower limb amputation. Evaluating the degree of ischaemia and probability of wound healing to decide which wounds will heal with routine ulcer treatment and which ones require immediate vascular surgery to maximise the chances of wound healing remains a clinical challenge.
The proposed pilot study is intended to examine if the measurements made by the Vascular Early Warning System (VEWS) device, which uses two light sources placed on the skin to determine blood volume in the skin, can be related to wound healing outcomes and hence confirm if it can enhance clinical decision making. The study will enrol up to twenty five men and women, over the age of 18 years, with an ischaemic foot ulcer. They will attend a single site hospital outpatient acute foot clinic. The study design will be explained verbally, and with written information to potential recruits. Participants will be entered into the study only if written consent is given. Recruitment will occur over five months; the duration of the study for each participant will be four weeks. Each participant will have a baseline measurement taken by the VEWS system at study entry. They will have a 3D photograph taken of their ischaemic ulcer weekly to determine ulcer volume and ulcer composition (how much healthy or dead tissue is in the wound). Participants who require vascular surgery or amputation after entering the study will remain in the study until the time of their surgery. Participants who withdraw for other reasons will be replaced. All participants will continue their routine wound care.
REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/1142
Date of REC Opinion
23 Aug 2013
REC opinion
Favourable Opinion