RESCUE Study
Research type
Research Study
Full title
Spinal Cord stimulation plus Usual Care vs. Usual Care alone in the management of non-reconstructable critical limb ischaemia: A feasibility randomised controlled trial.
IRAS ID
290566
Contact name
Anu Kansal
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
We plan to involve 50 people with poor circulation potentially leading to ulceration, gangrene and amputation (critical limb ischaemia) unsuitable for surgery, from South Tees Hospitals and Basildon University Hospitals selected by skin surface measurement of oxygen supply (TcPO2). Consistency of measurements between operators of TcPO2 measurement will be assessed prior to the trial with two clinicians in each location recording 2 readings 5 minutes apart, one sitting and one lying down, and the readings being compared for consistency (with a reference reading on the chest wall). Consenting individuals will be allocated randomly to receive usual care or SCS plus usual care. Usual care will be standardised in accordance with NICE guideline (NICE, 2012).
Participants will be assessed at baseline, 3 and 6 months. We will collect information on numbers screened for suitability, randomised and completing the trial, number of major amputations, pain intensity, walking distance, quality of life, patient satisfaction and health care utilisation.
REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0179
Date of REC Opinion
22 Jun 2022
REC opinion
Further Information Favourable Opinion