RAPID-1 Diabetic Foot Ulcer Study [Version 2.0]
Research type
Research Study
Full title
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. RAPID™* [Restorative Autologous Platelet biotherapies for treatment of Injuries & Delayed wound healing] Biodynamic Platelet Rich Plasma [PRP] Haematogel
IRAS ID
203851
Contact name
Sandip Sarkar
Contact email
Sponsor organisation
Biotherapy Services Ltd.
Eudract number
2018-003596-36
ISRCTN Number
ISRCTN55474813
Clinicaltrials.gov Identifier
REC Reference: 16/LO/2077, REC Reference: 16/LO/2077; REC Reference: 17/LO/1372, REC Reference: 17/LO/1372
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Diabetes has become a global health problem, often leading to diabetic foot ulcers. In spite of significant advances, most diabetic foot ulcers [DFUs] which fail to heal with current standard medical care. This has a significant impact on personal healthcare costs and leads to serious complications such as amputation (one diabetic amputation every 30seconds globally).
Current standard of treatment for DFUs involves various regimes of continuous dressings, weight off-loading, optimisation of vasculature and podiatry.
A treatment promoting the release of healing factors from a patients own blood (specifically platelets) has shown impressive results in the United States for chronic diabetic foot ulcers. However this treatment(Aurix) relies on the use of cattle-derived clotting agent to activate the patient's platelets, which is not sanctioned in the EU.
The RAPID Biodynamic Haematogel replicates the Aurix treatment formulation except for using the patient's own thrombin, instead of bovine thrombin. It involves taking blood from the patient and isolating the platelets and thrombin separately using an automatic sealed, sterile processing system. These are mixed together and vitamin C (ascorbic acid) added. This results in the immediate formation of a gel which is placed topically on the wound as a dressing. It works by releasing a concentrated boost of the patient's own wound healing factors which restores the patient's own abilities to heal the wound naturally.
This study will compare time to 100% healing of DFUs between RAPID™ PRP Gel + Usual and Customary Care [UCC] versus DFUs treated with UCC alone. The study is designed as an 18month, single-centre pilot study. 66 patients with DFUs will be recruited and randomly allocated into the 2 treatment groups.
The study also features a comparative one-year cost-utility analysis of the patients, and Quality of Life (QoL) in order to determine the costs and consequences associated with chronic DFUs and their treatments.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1372
Date of REC Opinion
21 Sep 2017
REC opinion
Favourable Opinion