Evaluating Wound Closure with OptiPulse™ for Foot Ulcers in Diabetes
Research type
Research Study
Full title
A Multi-center, Randomized Controlled Clinical Investigation Evaluating Wound Closure with OptiPulse™ versus Standard of Care in the Treatment of Non Healing Diabetic Foot Ulcers
IRAS ID
312005
Contact name
Richard Leigh
Contact email
Sponsor organisation
Compedica Limited
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
1301891, IRB; 53727, CPMS
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The OptiPulse™ is a device that looks like a boot and offloads high pressure areas of the foot where ulcerations occur using an ankle-foot orthosis (type of calliper). A rechargeable pump in the device rapidly inflates a pad underneath the arch of the foot and is designed to enhance blood circulation in the small blood vessels of the foot in patients with foot ulcers. This study will compare the outcomes of using OptiPulse™ and to aid healing in patients with diabetes and non-healing foot wounds and evaluate the performance and safety of OptiPulse™ in the treatment of chronic non healing diabetic foot ulcers after 12 weeks of treatment, time to heal, percentage area reduction of ulcers, and change in quality of life and pain scores compared with standard care. Participants will be 18 years of age or older and have diabetes and a foot ulcer with adequate blood supply to the foot. Participants will be excluded if they have bone infection, poor diabetes control, medications or interventions which will affect ulcer healing. Participants must have the capacity to understand the study, be available for all clinical appointments and be able to sign documentation for their willingness to participate.
Participants will attend a total of up to 15 clinic visits for assessment, depending on time to complete healing. At assessment participants will have a general physical examination, vascular assessment, foot x-ray, blood test and index ulcer assessments including pain measurement, photography and size measurement. On enrolment, participants target ulcer will be debrided (using a scalpel to remove dead tissue) and dressed with a standard dressing prior to application of OptiPulse™ or standard offloading device which will be worn by participants throughout the day whether walking or sitting. At weekly visits, participants will undergo further assessments of the wound, health and medication.REC name
London - Fulham Research Ethics Committee
REC reference
23/PR/0172
Date of REC Opinion
24 May 2023
REC opinion
Further Information Favourable Opinion