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

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ClinicalTrials.gov Identifier: NCT02224742
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: LeucoPatch Other: Usual care Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers
Actual Study Start Date : August 2013
Actual Primary Completion Date : October 2017
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224742


Locations
Show Show 32 study locations
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Investigators
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Principal Investigator: Frances Game, FRCP University Hospitals of Derby and Burton NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02224742    
Other Study ID Numbers: 12EN005
ISRCTN27665670 ( Other Identifier: ISRCTN )
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
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