Condition category
Skin and Connective Tissue Diseases
Date applied
31/08/2016
Date assigned
31/08/2016
Last edited
13/02/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Current plain English summary as of 13/02/2019:
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?
The Royal London Hospital Barts Health NHS Trust

When is the study starting and how long is it expected to run for?
August 2016 to August 2020

Who is funding the study?
Biotherapy Services Ltd (UK)

Who is the main contact?
Janet Hadfield


Previous 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?
Janet Hadfield

Trial website

Contact information

Type

Public

Primary contact

Ms Janet Hadfield

ORCID ID

Contact details

59-60 Gainsborough House
Thames Street
Windsor
SL4 1TX
United Kingdom

Additional identifiers

EudraCT number

2018-003596-36

ClinicalTrials.gov number

Protocol/serial number

Version 2.1

Study information

Scientific title

A Single Centre, Open Label Randomised Controlled Trial of the RAPID Biodynamic 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.

Acronym

RAPID-1 DFU

Study hypothesis

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.

Ethics approval

Current ethics approval as of 06/02/2019:
London City and East Research Ethics Committee, 13/10/2018, ref. 17/LO/1372.

Previous ethics approval:
NRSSPC NHSG [Grampian Scotland] - submission pending

Study design

Current study design as of 06/02/2019:
Single centre randomised controlled trial

Previous study design:
Multicenter randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Diabetic foot ulcers

Intervention

Current interventions as of 13/02/2019:
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.


Previous interventions:
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.

Intervention type

Other

Phase

Drug names

Primary outcome measure

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
7. Cost-effectiveness

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

01/08/2016

Overall trial end date

01/08/2020

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

66

Total final enrolment

66

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

01/02/2019

Recruitment end date

01/02/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Barts Health NHS Trust
The Royal London Hospital Whitechapel Road
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Biotherapy Services Ltd

Sponsor details

59-60 Gainsborough House
Thames Street
Windsor
SL4 1TX
United Kingdom

Sponsor type

Industry

Website

www.biotherapyservices.com

Funders

Funder type

Industry

Funder name

Biotherapy Services Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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.

IPD sharing statement: the datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/09/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/02/2019: The following changes were made: 1. The public title was changed from "RAPID™ Biodynamic Haematogel Platelet Rich Plasma (PRP) diabetic foot ulcer randomised controlled study" to "Are diabetic foot ulcers more likely to heal and heal faster when treated with RAPID biodynamic haematogel in addition to usual customary care?" 2. The recruitment start date was changed from 01/11/2016 to 01/02/2019. 3. The recruitment end date was changed from 01/05/2017 to 01/02/2020. 4. The IPD sharing statement was added. 5. The participant level data was updated. 6. The overall trial start date was changed from 01/02/2019 to 01/08/2016. 7. The interventions were updated. 8. The plain English summary was updated. 06/02/2019: The following changes were made: 1. The scientific title was changed from "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" to "A Single Centre, Open Label Randomised Controlled Trial of the RAPID* Biodynamic 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." 2. The EudraCT number was added. 3. The protocol number was added. 4. The overall trial start date was changed from 01/11/2016 to 01/02/2019. 5. The overall trial end date was changed from 31/10/2017 to 01/08/2020. 6. The intention to publish date was changed from 01/05/2017 to 30/09/2020. 7. The ethics approval was updated. 8. The trial participating centres were updated.