Leucopatch in the management of hard to heal diabetic foot ulcers

ISRCTN	ISRCTN27665670
DOI	https://doi.org/10.1186/ISRCTN27665670
ClinicalTrials.gov (NCT)	NCT02224742
Protocol serial number	14626
Sponsor	Nottingham University Hospitals NHS Trust (UK)
Funder	Reapplix (Denmark)

Submission date: 05/07/2013
Registration date: 05/07/2013
Last edited: 27/09/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Eleanor Harrison
Scientific

Nottingham Clinical Trials Unit
University of Nottingham
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Email	leucopatch@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Leucopatch in the management of hard to heal diabetic foot ulcers: a randomised controlled trial
Study acronym	DRN 819 Leucopatch II
Study objectives	Diabetic foot ulcers are the source of considerable suffering and cost and there are currently no wound care products available that have been demonstrated to improve healing, or that are cost effective. There have however been a small number of studies which have examined the use of platelets or fluid derived from platelets, either from the patients own blood or from blood bank products. These have suggested some promise, but have suffered from technical difficulties in making a suitable wound care product or the volume of blood required to derive the product. It is thought that the reason why they may work is that growth factors released by the platelets may stimulate the wound to heal. This study will be a formal, randomised controlled trial to assess a new device for creating a wound care product which is a plug or patch comprising fibrin, white cells and platelets derived from 18 mls of the patients own blood. The application of this fibrin/white cell/platelet patch to the patients wound on a weekly basis will be compared with usual best care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25 centres in the UK, Denmark and Sweden.
Ethics approval(s)	13/WM/0202; First MREC approval date 24/05/2013
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network; Subtopic: Both; Disease: Diabetic foot
Intervention	Leucopatch, topical application of a fibrin/white cell/platelet patch prepared by the Leucopatch device Study Entry : Registration and One or More Randomisations
Intervention type	Device
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Ulcer healing; Timepoint(s): 20 weeks after randomisation
Key secondary outcome measure(s)	Added 05/01/2017: Ulcer-related outcomes: 1. Time (days) to healing in those that heal by 20 weeks 2. The incidence of healing within 12 and 26 weeks 3. Change in ulcer area at 4, 12, 16, 20 and 26 weeks 4. Change in ulcer healing rate between the run-in-period and the first four weeks in the treatment period 5. The incidence of secondary infection 6. Number of days of systemic antibiotic therapy administered for infection of foot ulcer during the 20 weeks from randomisation 7. Durability of wound healing 12 weeks after complete wound healing Patient-related outcomes: 1. The incidence of major (above ankle) amputation affecting the target limb by 12, 20 and 26 weeks 2. The incidence of major amputation affecting the contralateral limb by 26 weeks 3. The incidence of minor (below ankle) amputation affecting the target limb by 12, 20 and 26 weeks 4. The incidence of minor amputation affecting the contralateral limb 5. Quality-of-life measured using SF-12 and EQ-5D at baseline, 12 and 20 weeks 6. Pain measured by VAS 7. Incidence of new anaemia Health economic analysis: 1. Cost effectiveness and cost utility
Completion date	31/05/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	269
Key inclusion criteria	1. People aged 18 years and over who have diabetes complicated by one or more ulcers on a foot or both feet below the level of the malleoli, excluding ulcers confined to the interdigital cleft 2. Those with more than one eligible ulcer will have one usually the largest or more clinically significant selected at screening as the index ulcer 3. Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50 % during a four week run-in period 4. HbA1c ≤108 mmol/mol at screening 5. The cross-sectional area of the index ulcer will be between ≥50 and ≤1000 mm2 at the end of the 4 week run-in period 6. At randomisation, the index ulcer will be clinically non-infected according to IDSA criteria 7. Either the ankle-brachial index (ABPI) in the affected limb will be between 0.50 and 1.40 or the dorsalis pedis pulse and/or tibialis posterior pulse will be palpable 8. Participants will have the capacity to understand study procedures, and will be able to provided written informed consent Target Gender: Male & Female ; Lower Age Limit 18 years
Key exclusion criteria	Current exclusion criteria as of 05/01/2017: 1. Haemoglobin concentration <105 g/L or 6.5 mmol/L at screening 2. Presence of sickle-cell anaemia, haemophilia, thrombocytopenia (<100x109/L) or other clinically significant blood dyscrasia 3. Known potential infectivity of blood products, including known HIV and hepatitis 4. Dialysis or an estimated GFR (based on cystatine C or serum creatinine) <20 ml/min/1.73m2 5. Increase in cross-sectional area of the index ulcer by ≥25% during the 4 week run-in period, or is either smaller than 50 mm2 or larger than 1000 mm2 at the end of that time 6. Clinical signs of infection of the index ulcer or reason to suspect that infection is present at randomisation. 7. Revascularisation procedure in the affected limb planned, or undertaken within the 4 weeks prior to screening 8. Current treatment with cytotoxic drugs or with systemically administered glucocorticoids or other immunosuppressants. 9. Treatment of foot ulcers with growth factors, stem cells or equivalent preparation within the 8 weeks prior to screening 10. The need for continued use of negative pressure wound therapy 11. Likely inability to comply with the need for weekly visits because of planned activity 12. Participation in another interventional clinical foot ulcer-healing trial within the 4 weeks prior to screening 13. Prior randomisation in this trial 14. Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent Previous exclusion criteria: 1. Haemoglobin concentration <105 g/L or 6.5 mmol/L at screening 2. Presence of sickle-cell anaemia, haemophilia, thrombocytopenia (<100x109/L) or other clinically significant blood dyscrasia 3. Known potential infectivity of blood products, including known HIV and hepatitis 4. Dialysis or an estimated GFR (based on cystatine C or serum creatinine) <20 ml/min/1.73m2 5. Increase in cross-sectional area of the index ulcer by ≥25% during the 4 week run-in period, or is either smaller than 50 mm2 or larger than 1000 mm2 at the end of that time 6. Revascularisation procedure in the affected limb planned, or undertaken within the 4 weeks prior to screening 7. Current treatment with cytotoxic drugs or with systemically administered glucocorticoids 8. Treatment of foot ulcers with growth factors, stem cells or equivalent preparation within the 8 weeks prior to screening 9. Likely inability to comply with the need for weekly visits because of planned activity 10. Participation in another interventional clinical foot ulcer-healing trial within the 4 weeks prior to screening 11. Prior enrolment in this trial 12. Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent
Date of first enrolment	15/07/2013
Date of final enrolment	31/05/2017

Locations

Countries of recruitment

United Kingdom
England
Denmark
Sweden

Study participating centre

Clinical Trials Unit

Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2018		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/09/2018: Publication reference added.
05/01/2017: the following changes were made to the trial record:
1. The overall trial end date was changed from 30/01/2016 to 31/05/2018.
2. The target number of participants was changed from 'Planned Sample Size: 250; UK Sample Size: 150' to 'Planned Sample Size: 269; UK Sample Size: 150'.
3. Denmark and Sweden were added to the countries of recruitment.