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LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Nottingham University Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT02224742
First received: August 22, 2014
Last updated: April 18, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcer Device: LeucoPatch Other: Usual care Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Nottingham University Hospitals NHS Trust:

Primary Outcome Measures:
  • Healing [ Time Frame: Within 20 weeks of randomisation ]
    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.


Estimated Enrollment: 250
Study Start Date: August 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LeucoPatch
Usual care supplemented by the application of LeucoPatch centrifugates that comprise autologous fibrin patches containing living white cells and platelets
Device: LeucoPatch
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.
Active Comparator: Usual care
Usual care provided in a multidisciplinary foot care clinic, in accordance with international guidelines
Other: Usual care

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02224742

Contacts
Contact: Eleanor Harrison 0115 82 31589 leucopatch@nottingham.ac.uk

Locations
Denmark
Steno Diabetes Center Recruiting
Gentofte, Denmark
Contact: Peter Rossing, MD       pro@steno.dk   
Principal Investigator: Peter Rossing, MD         
Herlev Hospital Recruiting
Herlev, Denmark
Contact: Morten Michelsen, MD       moismi02@heh.regionh.dk   
Principal Investigator: Morten Michelsen, MD         
Nordsjællands Hospital Recruiting
Hillerød, Denmark
Contact: Jan Sørensen, MD       j.soerensen@regionh.dk   
Principal Investigator: Jan Sørensen, MD         
Bispebjerg Hospital Recruiting
Kobenhavn NV, Denmark
Contact: Bo Jørgensen, MMSc       Bj05@bbh.regionh.dk   
Principal Investigator: Bo Jørgensen, MMSc         
Kolding Sygehus Recruiting
Kolding, Denmark, 6000
Contact: Kim Houlind, MMSc, PhD       kim.christian.houlind@rsyd.dk   
Principal Investigator: Kim Houlind, MMSc, PhD         
Odense University Hospital Recruiting
Odense, Denmark
Contact: Anna Marie Nielsen, MD       anna.marie.nielsen@rsyd.dk   
Principal Investigator: Anna Marie Nielsen, MD         
Viborg Sårcenter Recruiting
Viborg, Denmark
Contact: Eskild Henneberg, MD       eskild.w.henneberg@viborg.rm.dk   
Principal Investigator: Eskild Henneberg, MD         
Sweden
Skåne University Hospital Recruiting
Lund, Sweden
Contact: Magnus Löndahl, MD, PhD       magnus.londahl@med.lu.se   
Principal Investigator: Magnus Löndahl, MD, PhD         
United Kingdom
Royal Cornwall Hospitals NHS Trust Recruiting
Truro, Cornwall, United Kingdom, TRI 3LJ
Contact: Harvey Chant, FRCS       Harvey.Chant@rcht.cornwall.nhs.uk   
Principal Investigator: Harvey Chant, FRCS         
South Devon Healthcare NHS Foundation Trust Recruiting
Torquay, Devon, United Kingdom, TQ2 7AA
Contact: Ghislaine Spyer, MRCP, MD       gspyer@nhs.net   
Principal Investigator: Ghislaine Spyer, MRCP, MD         
The Ipswich Hospital NHS Trust Recruiting
Ipswich, Suffolk, United Kingdom, IP4 5PD
Contact: Gerrard Rayman, FRCP       gerry.rayman@ipswichhospital.nhs.uk   
Principal Investigator: Gerrard Rayman, FRCP         
The Mid Yorkshire Hospitals NHS Trust Recruiting
Pontefract, West Yorkshire, United Kingdom, WF8 1PL
Contact: Ryan D'Costa, FRCP       ryan.dcosta@midyorks.nhs.uk   
Principal Investigator: Ryan D'Costa, FRCP         
Bradford Teaching Hospitals NHS Foundation Trust Recruiting
Bradford, United Kingdom, BD9 6RJ
Contact: Donald Whitelaw, FRCP       Donald.Whitelaw@bthft.nhs.uk   
Principal Investigator: Donald Whitelaw, FRCP         
Derby Hospitals NHS Foundation Trust Recruiting
Derby, United Kingdom, DE22 3NE
Contact: Frances Game, FRCP       frances.game@nhs.net   
Principal Investigator: Frances Game         
United Lincolnshire Hospitals NHS Trust Recruiting
Lincoln, United Kingdom, LN2 5QY
Contact: Rajagopalan Sriraman, MRCP, PhD       Rajagopalan.Sriraman@ULH.nhs.uk   
Principal Investigator: Rajagopalan Sriraman, MRCP, PhD         
Norwich and Norwich University Hospitals NHS Foundation Trust Recruiting
Norwich, United Kingdom, NR4 7UY
Contact: Ketan Dhatariya, FRCP       ketan.dhatariya@nnuh.nhs.uk   
Principal Investigator: Ketan Dhatariya, FRCP         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: William Jeffcoate, FRCP       william.jeffcoate@gmail.com   
Principal Investigator: William Jeffcoate, FRCP         
City Hospitals Sunderland NHS Foundation Trust Recruiting
Sunderland, United Kingdom, SR4 7TP
Contact: Rahul Nayar, FRCP       Rahul.Nayar@chsft.nhs.uk   
Principal Investigator: Rahul Nayar, MRCP         
Royal Wolverhampton Hospitals NHS Trust Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Contact: Victor Oguntolu, MRCP, MSc       victor.oguntolu@nhs.net   
Principal Investigator: Victor Oguntolu, MRCP, MSc         
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Investigators
Principal Investigator: Frances Game, FRCP Derby Hospitals NHS Foundation Trust
  More Information

Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02224742     History of Changes
Other Study ID Numbers: 12EN005
ISRCTN27665670 ( Other Identifier: ISRCTN )
Study First Received: August 22, 2014
Last Updated: April 18, 2017

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases

ClinicalTrials.gov processed this record on June 27, 2017