LeucoPatch in Malleoli Ulcer Study

Study Overview
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Brief Summary
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An International Multicenter study evaluation, off the effect of the fully autologous growth factor-containing patch LeucoPatch, on healing of recalcitrant malleoli ulcers. To compare the impact of LeucoPatch as part of usual care in multidisciplinary Foot clinic settings, versus usual care in the same clinics on malleoli ulcers healing.

Detailed Description
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Diabetic Foot Ulcers are a common and severe complication, that affects Patients Life Quality. Healing time is often long and the Diabetic foot ulcer is the dominating not traumatic reason for leg amputation. Treatment of a diabetic foot ulcer requires debridement, offloading, regularly foot care, specially tailored shoes, antimicrobial treatment, and sometimes even surgical interventions. Despite all these interventions the diabetic foot ulcer may not heal. Malleoli ulcers in patients without diabetes share several features of pathogenesis and lack of healing potentials with the Diabetic Ulcer. Like the features of pathogenesis and lack of healing potential and are therefore included in this study. Research has shown that other methods such as Growth factors may be a way to enhance the chance of healing. Growth Factors have been shown to have a positive effect in studies, but no products that are characterized as autologous have as yet obtained positive results in controlled studies. LeucoPatch is produced solely from a patient´s own blood without addition, and is autologous. LeucoPatch appears as an elastic membrane and can be fitted to the individual ulcer. LeucoPatch is shown to contain as many or more growth factors as existing products, and has a high concentration of fibrin, platelets and leukocytes. A non-controlled study was made on ulcers less than 10cm 2 and 52% had competed epithelization after 20 weeks. An International randomized multicenter trial is ongoing to evaluate the efficacy and safety of LeucoPatch on healing of hard to heal diabetic foot ulcers below the malleoli. This Study is designed to test the healing effect of the LeucoPatch on malleoli ulcers, the Patient will be randomized and the healing will be confirmed by a blinded observer.

Official Title
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LeucoPatch in Malleoli Ulcer Study

Conditions
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Diabetic Malleoli Ulcers, Malleoli Ulcers

Intervention / Treatment
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* Other: LeucoPatch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Foot ulcer at the malleoli area between 0,25 cm² and 5,0 cm² Foot ulcer duration more than 6 weeks No need for arterial revascularisation- as judged by the Investigator informed consent Exclusion Criteria: Hemoglobin concentration under 6.5 mmol/l screening Non-compliant with blood-letting Clinically infected ulcer Patient planned for or has had a revascularization procedure in the affected leg within the last 8 weeks The ulcer have been treated with growth factors in the last 8 weeks History of deep venous insufficiency, chronic venous leg ulcer or stasis dermatitis Breast-feeding women or fertile women not agreeing to use an effective method of contraception Participation in another clinical ulcer-healing study within the last 4 weeks Patient has previously been randomized in this study Judgement by the investigator that the patient is not able to participate in the study

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LeucoPatch<br>Treatment with usual ulcer care and LeucoPatch once weekly up til 24 weeks or until healing. | Other: LeucoPatch<br>* LeucoPatch is an fully autologous growth factor-containing dressing<br>|
| Active Comparator: Usual care followed by LeucoPatch<br>Usual care weekly for 12 weeks, if the ulcer persist after the12 weeks LeucoPatch treatment will be started for up to 12 weeks or until healing. | Other: LeucoPatch<br>* LeucoPatch is an fully autologous growth factor-containing dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of malleoli ulcer (YES/NO) | Confirmed by a blinded observer | up to 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing of malleoli ulcer | Weeks from Inclusion to Wound healing | 24 weeks | 
| Ulcer area reduction based on Image J measured on acetate drawing |  | 24 weeks | 
| Health related quality of life questionnaire SF12 | Short Form 12 questionnaire (quality of life)SF-12 | week 0, week 12, and week 24 | 
| Health related quality of life questionnaire EQ-5D | Euroquol-D5 questionnaire(mood and function) EQ-5D | week 0, week 12, and week 24 | 
| Pain at ulcer location | VAS Score (Visual Analogue Scale) | week 0, week 6, week 12 and week 24 | 
| Z scores of combined plasma concentration of growth factors, cytokines and inflammatory markers |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malleoli ulcers, Diabetes, Healing, Dressing, LeucoPatch