LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers
2 other identifiers
interventional
269
3 countries
32
Brief Summary
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 patient's 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 United Kingdom, Denmark and Sweden.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2013
Longer than P75 for phase_4
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 22, 2014
CompletedFirst Posted
Study publicly available on registry
August 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedJune 25, 2018
June 1, 2018
4.2 years
August 22, 2014
June 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Healing
Healing will be defined as complete epithelialisation without discharge that is maintained for 4 weeks and is confirmed by an observer blind to randomisation group.
Within 20 weeks of randomisation
Study Arms (2)
LeucoPatch
EXPERIMENTALUsual care supplemented by the application of LeucoPatch centrifugates that comprise autologous fibrin patches containing living white cells and platelets
Usual care
ACTIVE COMPARATORUsual care provided in a multidisciplinary foot care clinic, in accordance with international guidelines
Interventions
LeucoPatch® is prepared by centrifuging one or more 18mL aliquots of the participant's venous blood in the LeucoPatch device and bench-top centrifuge. The centrifugation yields a tough layer of fibrin, with viable white cells and platelets, and this is applied directly to the wound surface using sterile forceps. The wound is then covered with an inert primary dressing, secondary protective dressing and the ulcerated area protected with appropriate off-loading. The patch is prepared and applied each week for up to 20 weeks or until the wound is judged healed.
Usual wound care provided in a multidisciplinary foot care clinic , in accordance with international guidelines. Components of usual wound care include: * Formal assessment of ulcer and surrounding skin * Provision of any necessary off-loading * Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) * Appropriate dressing products * Appropriate antibiotic therapy * Nutrition and self care * Optimal glycaemic control * Revascularisation if deemed clinically necessary * Continued close observation
Eligibility Criteria
You may qualify if:
- 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.
- Those with more than one eligible ulcer will have one - usually the largest or more clinically significant - selected at screening as the index ulcer.
- 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.
- The cross-sectional area of the index ulcer will be ≥50 and ≤1000 mm2 at the end of the 4 week run-in period.
- At randomisation, the index ulcer will be clinically non-infected according to IDSA criteria
- 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.
- HbA1c ≤108 mmol/mol at screening
- Participants will have the capacity to understand study procedures, and will be able to provide written informed consent.
You may not qualify if:
- Haemoglobin concentration \<105 g/L or 6.5 mmol/L at screening.
- Presence of sickle-cell anaemia, haemophilia, thrombocytopenia (\<100x109/L) or other clinically significant blood dyscrasia
- Known potential infectivity of blood products, including known HIV and hepatitis
- Dialysis or an estimated GFR (based on cystatine C or serum creatinine) \<20 ml/min/1.73m2
- 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.
- Clinical signs of infection of the index ulcer or reason to suspect that infection is present at randomisation.
- Revascularisation procedure in the affected limb planned, or undertaken within the preceding 4 weeks.
- Current treatment with cytotoxic drugs or with systemically administered glucocorticoids or other immunosuppressants.
- Treatment of foot ulcers with growth factors, stem cells or equivalent preparation within the preceding 8 weeks
- The need for continued use of negative pressure wound therapy
- Likely inability to comply with the need for weekly visits because of planned activity.
- Participation in another interventional clinical foot ulcer-healing trial within last the 4 weeks at the time of screening.
- Prior randomisation in this trial.
- Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Steno Diabetes Center
Gentofte Municipality, Denmark
Herlev Hospital
Herlev, Denmark
Nordsjællands Hospital
Hillerød, Denmark
Kolding Sygehus
Kolding, 6000, Denmark
Bispebjerg Hospital
København NV, Denmark
Odense University Hospital
Odense, Denmark
Viborg Sårcenter
Viborg, Denmark
Centralsjukhuset Kristianstad
Kristianstad, Sweden
Skåne University Hospital
Lund, Sweden
Karolinska University Hospital
Solna, Sweden
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, TRI 3LJ, United Kingdom
South Devon Healthcare NHS Foundation Trust
Torquay, Devon, TQ2 7AA, United Kingdom
The Ipswich Hospital NHS Trust
Ipswich, Suffolk, IP4 5PD, United Kingdom
The Mid Yorkshire Hospitals NHS Trust
Pontefract, West Yorkshire, WF8 1PL, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, S75 2EP, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Chorley, PR7 1PP, United Kingdom
Dartford and Gravesham NHS Trust
Dartford, DA2 8DA, United Kingdom
Derby Hospitals NHS Foundation Trust
Derby, DE22 3NE, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, DY1 2HQ, United Kingdom
Royal Devon & Exeter NHS Foundation Trust
Exeter, EX2 5DW, United Kingdom
Gateshead Health NHS Foundation Trust
Gateshead, NE9 6SX, United Kingdom
Harrogate and District NHS Foundation Trust
Harrogate, HG2 7SX, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX, United Kingdom
University Hospitals of Leicester NHSTrust
Leicester, LE5 4PW, United Kingdom
United Lincolnshire Hospitals NHS Trust
Lincoln, LN2 5QY, United Kingdom
Norwich and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, RG1 5BS, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S5 7AU, United Kingdom
City Hospitals Sunderland NHS Foundation Trust
Sunderland, SR4 7TP, United Kingdom
Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
Game F, Jeffcoate W, Tarnow L, Jacobsen JL, Whitham DJ, Harrison EF, Ellender SJ, Fitzsimmons D, Londahl M; LeucoPatch II trial team. LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):870-878. doi: 10.1016/S2213-8587(18)30240-7. Epub 2018 Sep 19.
PMID: 30243803DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frances Game, FRCP
University Hospitals of Derby and Burton NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2014
First Posted
August 25, 2014
Study Start
August 1, 2013
Primary Completion
October 1, 2017
Study Completion
May 1, 2018
Last Updated
June 25, 2018
Record last verified: 2018-06