LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study
NCT ID: NCT03370055
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-11-02
2020-05-01
Brief Summary
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The healing rate will be measured as relative reduction of 'problematic wound area' at 8 weeks
Detailed Description
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The subpopulation is characterized by either referral from other specialties with non-healing wounds of various etiologies and no or limited options of medical, surgical, or reconstructive plastic surgery procedures to treat the wounds; or the wounds are a consequence of previous reconstructive procedures with unsuccessful outcome and no or limited options of further reconstructive surgery. This group of patients often needs wound treatment for a very long period (months-years) to heal, in spite of best practice standards of wound treatment. Treatment with xenogeneic acellular dermal matrixes and autologous full- or split-thickness skin grafts may be an option, but it often requires general anesthesia and a 2-staged approach. The LeucoPatch may be a new solution in wound treatment, which can be used in the outpatient clinic, to promote faster healing in patients with chronic, non-healing wounds with exposed bone or tendon
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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LeucoPatch®
Usual wound care and LeucoPatch® treatment for 8 weeks, with the offer of additional 8 weeks treatment with LeucoPatch®
LeucoPatch®
LeucoPatch® is an elastic membrane produced by the patients own venous blood by centrifugation, and one or two is placed on the wound once a week The LeucoPatch® consist of the fibrin Leucocytes and growth factors from the patients own blood
Control,
Usual wound care in a specialized clinic
Control
Usual wound care for 8 weeks, with the offer of 8 weeks of LeucoPatch® treatment after the first 8 weeks
LeucoPatch®
LeucoPatch® is an elastic membrane produced by the patients own venous blood by centrifugation, and one or two is placed on the wound once a week The LeucoPatch® consist of the fibrin Leucocytes and growth factors from the patients own blood
Control,
Usual wound care in a specialized clinic
Interventions
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LeucoPatch®
LeucoPatch® is an elastic membrane produced by the patients own venous blood by centrifugation, and one or two is placed on the wound once a week The LeucoPatch® consist of the fibrin Leucocytes and growth factors from the patients own blood
Control,
Usual wound care in a specialized clinic
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥18 years
3. A documented clinically relevant history of chronic wound with exposed tendon and/or bone. Chronic is defined as a non-healing wound over the past 4 weeks with standard care in a specialized clinic.
4. 'Problematic wound area' between 0.25 and 10.0 cm2 measured by Image J at S1- irrespective of the total wound size
5. The subject must be willing and able to comply with the trial protocol
Exclusion Criteria
2. Non-compliance with blood-letting
3. Clinically infected wound or suspected osteomyelitis in the wound area
4. For lower extremity wounds: Critical peripheral artery disease (absence of foot pulse and Ankle-Branchial Pressure Index, ABPI \<0.9 and ankle blood pressure \< 50 mmHg)
5. For lower extremity wounds: History of vascular by-pass graft or other endovascular intervention within 3 months prior to inclusion.
6. Malignancy in the wound area
7. Need for dialysis
8. Hemophilia, leukaemia or other significant blood disease
9. History of alcohol or drug abuse within the last year
10. Weight abnormality (BMI \< 20 kg/m2 or \>30 kg/m2)
11. Pregnant or lactating woman
12. Women of childbearing potential who are not using sufficient contraceptives
13. Patient has previously been randomised in this study
14. Participation in another investigational drug trial within the last 10 weeks
18 Years
ALL
No
Sponsors
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Nordsjaellands Hospital
OTHER
Reapplix
OTHER
Jais Oliver Berg
OTHER
Responsible Party
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Jais Oliver Berg
Senior Consultant,
Principal Investigators
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Lise Tarnow, Professor
Role: STUDY_CHAIR
Nordsjaellands Hospital
Locations
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Herlev - Gentofte Hospital
Herlev, Regionh, Denmark
Countries
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Other Identifiers
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LiNWEX
Identifier Type: -
Identifier Source: org_study_id