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

Reapplix

Status

Completed

Conditions

Diabetic Foot Ulcers

Treatments

Device: LeucoPatch treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01454401

H-4-2010-090

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.