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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Weekly LeucoPatch treatment	LeucoPatch treatment	Weekly treatment of diabetic foot ulcers with LeucoPatch

Primary Outcome Measures

Name	Time	Method
Ulcer Healing Within 20 Weeks	20 weeks	Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.

Secondary Outcome Measures

Name	Time	Method
Ulcer Healing Within 12 Weeks.	12 weeks	Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population

Locations (7): Knowledge Center for woundhealing, Bispebjerg Hospital
🇩🇰
Copenhagen, Denmark
Steno Diabetes Center
🇩🇰
Gentofte, Denmark
Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic
🇩🇰
Herlev, Denmark
Vascular Center, Wound Clinic Kolding Hospital
🇩🇰
Kolding, Denmark
University center for woundhealing, Odense Hospital
🇩🇰
Odense, Denmark
Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic
🇸🇪
Lund, Sweden
Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic
🇸🇪
Ängelholm, Sweden
Knowledge Center for woundhealing, Bispebjerg Hospital
🇩🇰Copenhagen, Denmark