Feasibility Study of the ReCell Device in Diabetic Foot Ulcers
Research type
Research Study
Full title
A Feasibility Study of the ReGenerCell® Autologous Cell Harvesting Device for Diabetic Foot Ulcers
IRAS ID
171345
Contact name
Tawqeer Rashid
Contact email
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The purpose of the study is to gain additional clinical experience using the ReCell Autologous Cell Harvesting Device (ReCell) in treating patients with diabetic foot ulcers in combination with conventional treatments.
Patients with diabetes are at increased risk of developing foot wounds, either as a result of impaired blood circulation or from injuring their foot as a result of loss of pain and touch sensations. In both cases the wounds are difficult to heal and require medical intervention.
ReCell is a medical device in which the healthcare professional uses a small amount of the patients own skin to restart healing in wounds where normal healing has gone wrong. It has already been shown to improve healing in patients with ulcers which have remained unhealed despite other treatments.
The study has assessments called eligibility and screening to check patients are suitable to be included in the study. A healthcare professional will review the patients’ notes and make the decision to discuss the study with the patient. All patients will be provided with written information, given time to discuss the risks and benefits of participation and will provide written informed consent to participate in the study prior to any study procedures.
The study will be conducted within several NHS Hospital Clinics for one year (28 weeks for each patient). Following a 2 week time of observation, the patient will receive up to 3 ReCell treatments (initial treatment then additional treatments at 1 and 6 weeks if the doctor judges necessary). Following treatment there are evaluations of safety, wound healing, pain, exudate (discharge), Quality of Life, treatment costs and recurrence of ulcers at 1, 2, 4, 6, 10, 14, 20 and 26 weeks from the initial treatment.
This information will be used for further development of clinical practice guidelines and clinical trial design.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0769
Date of REC Opinion
26 Oct 2015
REC opinion
Favourable Opinion