N/A
Completed N=44
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
Source: ClinicalTrials.gov NCT01454401 ↗Enrolled (actual)
44
Serious AEs
13.3%
Results posted
Oct 2016
Primary outcomePrimary: Ulcer Healing Within 20 Weeks — 23; 23 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ulcer Healing Within 20 Weeks |
23; 23 | — |
| SECONDARY Ulcer Healing Within 12 Weeks. |
15; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- Type I or Type II Diabetes
- Age of wounds > 6 weeks
- Wound area 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.
Data sourced from ClinicalTrials.gov (NCT01454401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.