RAPID-1 Diabetic Foot Ulcer Study

• Research type

  Research Study

• Full title

  Platelet Rich Plasma Biotherapies ‘Project RAPID’ [Restorative Autologous Platelet biotherapies for Injuries & Delayed wound healing]. A Randomised Controlled Trial of autologous Platelet Rich Plasma biotherapies in the management of adult patients with recalcitrant diabetic foot wounds. RAPID-1: Diabetic Foot Ulcer Randomised Controlled Study

• IRAS ID

  203851

• Contact name

  Sandip Sarkar

• Sponsor organisation

  Biotherapy Services Ltd.

• ISRCTN Number

  ISRCTN55474813

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  There is a worldwide pandemic of diabetic foot ulcers which fail to heal with standard medical care. This results in huge personal and healthcare costs as well as serious complications such as amputation (one diabetic amputation every 30seconds globally). Once correctable factors are accounted for, a large proportion of these patients don't heal their wounds due to diabetes-associated deficiencies in the standard wound healing processes.

  A new patented treatment (Aurix) for diabetic foot ulcers that cannot be healed by standard means within six weeks has shown impressive results in the United States. However, this treatment relies on the use of cattle-derived clotting agent (thrombin), which is not sanctioned in the EU. However, the "RAPID" treatment replicates the same treatment formulation, using the patient's own thrombin. It involves taking blood from the patient and isolating certain blood components - platelets and thrombin 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 used directly 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 trial would aim to demonstrate faster healing of these complex wounds by comparing patients with such chronic diabetic foot wounds having only best standard therapy with those having best standard therapy as well as the RAPID therapy.

  66 patients will be recruited across multiple NHS hospitals and randomly allocated into 2 groups. The patients will know which treatment they receive, and if allocated to best standard therapy alone, will be given the opportunity to move over to the RAPID treatment after 8 weeks if the wound is not achieving 50% area reduction every 4 weeks.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  16/LO/2077

• Date of REC Opinion

  23 Dec 2016

• REC opinion

  Unfavourable Opinion