LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). By subgrouping of the treated wounds (similar to the historical controls used) an assessment of which of the patient and wound-related factors that might indicate a beneficial effect of LeucoPatch™ is sought.

Detailed Description
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Summary: Treatment Study The goal of the LeucoPatch ™ study is to investigate the effect of LeucoPatch ™ in diabetic foot ulcer. LeucoPatch ™ is a biologically active dressings which are made solely by the patient's own blood (autologous). It is produced in the CE (European Conformity) marked LeucoPatch™ Device and contains no additives. In this treatment study up to 75 typical diabetic patients with foot ulcers are included. These wounds are typically chronic and lead to reduced quality of life and ability to work, and extensive treatment costs. Furthermore, these wounds often lead to amputations.The study is a multicenter study in which up to 10 wound clinics are expected to be involved. The primary endpoint is time to complete healing, the secondary endpoint is change in wound size.

Official Title
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LeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Device: LeucoPatch treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Type I or Type II Diabetes Age of wounds > 6 weeks Wound area <10 cm2 Wounds: Texas degree ≤ type IIa Perfusion status: toe pressure> 30 mmHg, or transcutaneous oxygen measurement (TcPO2)> 30 mmHg on the foot (measured within the last 3 months) or palpable foot pulse (equivalent to> 60 mmHg) Diabetes control: HbA1c <12% Adequate off-loading (Walker, therapy sandals etc.) The patient can adhere to the treatment protocol and is expected to conclude the study Written informed consent Exclusion Criteria: Non-Danish or Swedish speaking Dementia Pregnant or nursing women The patient cannot tolerate blood donation Hemoglobin : < 6,5 mmol/l or 105 g/l Haemophilia, Sickle cell anemia, severe thrombocytopenia, and leukemia or blood dyscrasias. Patient on dialysis Clinical signs of infection - including osteomyelitis (probe to bone). Necrosis of the wound 40% change (+/-) in ulcer area in a 2-week run-in period with optimal therapy. Blood vessel reconstruction within the last 4 weeks. Participation in other clinical wound healing studies in the last 30 days. Failure to comply with study protocol in the 2-week run-in period.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Weekly LeucoPatch treatment<br>Weekly treatment of diabetic foot ulcers with LeucoPatch | Device: LeucoPatch treatment<br>* weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer Healing Within 20 Weeks | Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population. | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer Healing Within 12 Weeks. | Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population | 12 weeks |