LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study

Study Overview
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Brief Summary
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The trial compare the healing rate of chronic wounds with exposed tendon or bone ('problematic wound area') with LeucoPatch® treatment for 8 up to 16 weeks in addition to usual care versus usual care. The healing rate will be measured as relative reduction of 'problematic wound area' at 8 weeks

Detailed Description
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A certain subpopulation of plastic surgery patients has chronic, non-healing wounds with exposed bone or tendon e.g. located on the scalp or extremities. The chronic non-healing wounds are characterized by no significant wound area reduction within 4 weeks of standard wound treatment. Standard wound treatment includes mechanical or sharp serial debridement and low pressure irrigation for cleansing and wound dressings ensuring moist wound healing. Exposed bone or tendon in a chronic wound can be described as a potentially 'problematic wound area', since the healing by sound granulation tissue from the soft tissue sides of the wound to cover the problematic wound area is often reduced or absent. 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

Official Title
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LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study

Conditions
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Wound Healing Delayed

Intervention / Treatment
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* Device: LeucoPatch®
* Other: Control,


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained before any trial related procedures are performed Aged ≥18 years 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. 'Problematic wound area' between 0.25 and 10.0 cm2 measured by Image J at S1- irrespective of the total wound size The subject must be willing and able to comply with the trial protocol Exclusion Criteria: Haemoglobin < 6.0 mmol/l available at screening (see 10.10) Non-compliance with blood-letting Clinically infected wound or suspected osteomyelitis in the wound area 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) For lower extremity wounds: History of vascular by-pass graft or other endovascular intervention within 3 months prior to inclusion. Malignancy in the wound area Need for dialysis Hemophilia, leukaemia or other significant blood disease History of alcohol or drug abuse within the last year Weight abnormality (BMI < 20 kg/m2 or >30 kg/m2) Pregnant or lactating woman Women of childbearing potential who are not using sufficient contraceptives Patient has previously been randomised in this study Participation in another investigational drug trial within the last 10 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: observer blinded, randomised, controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LeucoPatch®<br>Usual wound care and LeucoPatch® treatment for 8 weeks, with the offer of additional 8 weeks treatment with LeucoPatch® | Device: LeucoPatch®<br>* 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<br>Other: Control,<br>* Usual wound care in a specialized clinic<br>|
| Placebo Comparator: Control<br>Usual wound care for 8 weeks, with the offer of 8 weeks of LeucoPatch® treatment after the first 8 weeks | Device: LeucoPatch®<br>* 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<br>Other: Control,<br>* Usual wound care in a specialized clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing rate of Problematic wound area | Measured as relative reduction of Problematic wound area | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete 'problematic wound area´coverage | Full coverage with granulation tissue of the 'Problematic wound area´ making split -thickness-skin-transplantation for full wound coverage possible | 8 weeks or until 16 weeks | 
| Complete healing of target wound | Defined as confirmed confirmed wound closure of target wound i.e. skin reepithelization without drainage or dressing requirements (sustained for 2 weeks) | 8 or until 16 weeks | 
| Time to complete healing or coverage with granulation tissue | Defined as time from randomisation to first study visit with confirmed healing or coverage with granulation tissue | until 16 weeks | 
| Long -term followup | Occurence of complete healing 36 weeks after randomisation | 36 weeks | 
| Local pain | Local pain measured with Visual Analogue Scale (VAS ) | 8 to 16 weeks | 
| Safety | Data on adverse events and serious adverse events including major clinical events will be compared between treatment groups as will changes in haemoglobin | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exposed tendon or bone, LeucoPatch, Plastic Surgery, Granulation tissue, Wound