A Randomised Controlled Clinical Study Comparing the Efficacy and Safety of an Autologous Standardised Leukocyte‐Poor Platelet Gel With Standard Care for the Treatment of Chronic Neuropathic Diabetic Foot Ulcers

ABSTRACT

This randomised controlled clinical trial compared the efficacy of a standardised autologous platelet gel (RegenWound gel) (n = 48) with a standard care treatment (hydrocellular or hydrocolloid dressing) (n = 48) for the treatment of hard-to-heal foot ulcers in type 1 or 2 diabetes mellitus patients > 18 years old. The primary outcomes were the percentage of ulcers healed 6 weeks after treatment commenced. The secondary outcomes were the average healing time, the time course of the healing process, the local tolerance, and the acceptability of the treatment by the patient compared to the standard treatment. At the 6 weeks end-of-treatment visit (ETV), 56.5% of the patients in the RegenWound gel group and 20.0% of the patients in the control group had completely healed. Healing continued to evolve after the ETV and reached 77.3% at end-of-study visit 2 (12 weeks) in the RegenWound gel group, compared to 35.1% for the control group. The treatment was well tolerated and safe. RegenWound gel could be an effective treatment for diabetic foot ulcers, with most patients being healed within 6 weeks of treatment, and on average 1 to 2 treatments being needed.

Trial Registration: ISRCTN10032417