A Single Centre, Open Label, Randomised Controlled Trial of the RAPID™ * PRP (Platelet Rich Plasma) Haematogel Wound Care Treatment in addition to Usual and Customary Care, (UCC); compared to Usual and Customary Care (UCC) alone, in the management of adult patients with chronic Diabetic Foot Ulcers.
Disease area: Diabetes
Status: Actively recruiting
Chief Investigator: Mr Sandip Sarkar
Sponsor: Biotherapy Services Ltd
Funder: Sponsor funded
ISRCTN Ref: 55474813
The purpose of this study is to see if faster, permanent wound healing can be achieved in patients with difficult/slow to heal diabetic foot ulcers by amplifying your body’s own healing mechanisms. By placing the natural wound-healing growth factors found in your own blood directly in the wound itself, the proposed treatment aims to explore whether this results in a local boosting of the natural healing process and therefore healing of your wound. The healing factors are contained within platelets – specialised cells present in the bloodstream.
The RAPID™ Platelet Rich Plasma (PRP) Gel treatment involves taking a small amount [50mls or about 3 tablespoons] of blood from the patient, which will be processed within a specialised blood processing machine to form a PRP Gel ‘dressing’. This dressing is made up of the patients own concentrated platelets with added vitamin C and will be placed onto the wound, aiming to assist the healing process. This will be repeated weekly until the wound cavity is completely filled out.
66 patients with slow-healing diabetic foot ulcers (>12week duration), taking place at the Royal London Hospital. It includes a 12 week treatment period and 6 month follow up.
For further information on this study contact:
Mr Sandip Sarkar