DISCOVERY
Research type
Research Study
Full title
Assessment of the efficacy and safety of a new medical device in the local treatment of diabetic foot ulcers (DFUs): a prospective, randomized, controlled, double-blind, European, multicentre clinical trial.
IRAS ID
220164
Contact name
Michael Edmonds
Contact email
Sponsor organisation
URGO Research Innovation and Development
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
BRC 2016-A01 154-47,
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
Metformin is currently widely used as an oral drug for the treatment of diabetes and is recognised for its capacity to make blood sugar levels return to normal. Scientific evidence suggests that Metformin, when applied topically may help promote healing of foot ulcers in patients with diabetes.
Diabetic Foot Ulcers are a serious, yet common complication of diabetes mellitus, affecting approximately 15% of the world's diabetic population at least once in their lifetime. They are complex, chronic wounds which have a major long-term impact on the morbility, mortality and patient's quality of life. DFU's present a complex and costly therapeutic challenge and healing rates remain poor.
An innovative wound healing dressing containing Metformin as an ancillary compound has been developed. The main objective of this study is therefore to measure the wound healing action of the wound healing dressing on diabetic foot ulcers. A computer system (IWRS) will randomly assign patients to either receive a neutral dressing containing no active substance, a dressing containing 3% active substance (dose 1) or a dressing containing 7% active substance (dose 2). When introduced into the medical device, the active substance Metformin HCl is designated as LU3103209.
Clinical examination of the target diabetic foot ulcer as well as photographs, tracing and measurement of the wound surface area will be used to determine wound healing rate of the three devices at the end of treatment.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
17/WM/0194
Date of REC Opinion
8 Jun 2017
REC opinion
Further Information Favourable Opinion