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: Not 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