Plain English Summary
Background and study aims
Some people with diabetes develop diabetic foot ulcers - open wounds or sores on the skin that are slow to heal. This results in huge personal and healthcare costs as well as serious complications such as amputation. 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 a cow-derived clotting agent (thrombin), which is not allowed in the EU. However, the RAPID Biodynamic haematogel treatment provides the same treatment using the patient's own thrombin. It involves taking blood from the patient and isolating certain blood components (platelets and thrombin). These are mixed together and vitamin C (ascorbic acid) is 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 study aims to find out whether RAPID Biodynamic haematogel treatment results in faster healing of these complex wounds.
Who can participate?
Patients aged 18 and over with diabetic foot ulcers
What does the study involve?
Participants are randomly allocated into two groups. One group receives the best standard treatment while the other group receives the best standard treatment as well as the RAPID treatment. Wounds are treated until full wound closure is achieved. Participants allocated to best standard treatment are given the opportunity to move over to the RAPID treatment after 8 weeks if the wound is not healing.
What are the possible benefits and risks of participating?
The RAPID Biodynamic haematogel has shown very good wound healing in previous studies with no side effects. The treatment uses the patients' own blood so the risk is low.
Where is the study run from?
1. The Barts Health NHS Trust (UK)
2. Ninewells Hospital & Medical School (UK)
When is the study starting and how long is it expected to run for?
November 2016 to October 2017
Who is funding the study?
Biotherapy Services Ltd (UK)
Who is the main contact?
A randomised controlled trial of autologous RAPID™ Biodynamic Haematogel Platelet Rich Plasma compared with usual and customary care in the management of adult patients with chronic diabetic foot ulcers to investigate healing rates
Diabetic foot ulcers (DFUs) treated with RAPID© (Restorative Autologous Platelet-derived biotherapies for Injuries and Delayed wound healing) Biodynamic Haematogel + Usual and Customary Care (UCC) are more likely to heal and will heal faster than diabetic foot ulcers treated with UCC alone.
NRSSPC NHSG [Grampian Scotland] - submission pending
Multicenter randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Diabetic foot ulcers
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomised trial in which DFUs will be treated using the RAPID© Biodynamic Haematogel Autologous Platelet Rich Plasma [PRP] treatment in comparison to the usual and customary care [UCC] wound dressing and treatment regimes.
Patients are randomised to receive either:
1. The RAPID© Biodynamic Haematogel autologous Platelet Rich Plasma [PRP] treatment every 4-7 days + usual and customary care [UCC]
2. UCC alone
Wounds will be treated until full wound closure is achieved. Those patients in the UCC not healed after 8 weeks will be offered the opportunity to cross over into the RAPID treatment arm.
Primary outcome measures
The proportion of healed DFUs at 12 weeks
Secondary outcome measures
1. Incidence of amputations
2. Proportion of completely healed DFUs
3. Change in the W-QOL (Quality of Life with Chronic Wounds short-form instrument) mean score
4. Visual analogue scale pain score
5. Wound infection
6. Wound complications
Wounds will be examined between 4-7 days until closure of wound. Followed up within 6 months once wound healing achieved.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. ≥18 years of age
2. Type I or II diabetes requiring medical treatment as determined by the physician
3. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a University of Texas DFU Classification that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
4. For subjects with potentially multiple eligible DFUs, the largest ulcer will be selected as the Index Ulcer for study. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
5. Debrided ulcer size between 0.5 cm2 and 50 cm2
6. Subject has received UCC care for ≥ 2 weeks at treating wound clinic
7. Demonstrated adequate offloading regimen
8. Duration of wound ≥ 1 month at first visit
9. Subject must be willing to comply with the Protocol, which will be assessed by the enrolling clinician
10. The wounds require intervention by a surgeon or specialist clinician
11. Patients must have adequate vasculature, i.e. palpable pedal pulses or in line flow-to-foot on angiogram
Target number of participants
Participant exclusion criteria
1. Patients who refuse consent to participate in the study
2. Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by the RAPID© biodynamic haematogel
3. Ulcers not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
4. Patients on chemotherapeutic agents or any malignancy in the wound area
5. Subjects who are cognitively impaired
6. Serum albumin of less than 2.5 g/dL
7. Plasma platelet count of less than 100 x 109/L
8. Haemoglobin of less than 10.5 g/dL
9. Subject has inadequate venous access for repeated blood draw required for the RAPID biodynamic haematogel administration
10. Abnormal blood clotting dyscrasia, e.g. haemophilia
11. Evidence of bacteraemia, septicaemia or endocarditis
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
The Barts Health NHS Trust
The Royal London Hospital Whitechapel Road
Trial participating centre
Ninewells Hospital & Medical School
Ninewells Hospital & Medical School Research & Development Office Residency Block Level 3 George Pirie Way
Biotherapy Services Ltd
59-60 Gainsborough House
Biotherapy Services Ltd (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The findings will be reported to the NIHR, the National Institute of Clinical Excellence, the Department of Health and the MHRA. They will also be published in leading academic journals.
Intention to publish date
Participant level data
Available on request
Results - basic reporting