Diabetic Foot Ulcers Clinical Trial
Official title:
LeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
NCT number | NCT01454401 |
Other study ID # | H-4-2010-090 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2010 |
Est. completion date | January 2013 |
Verified date | March 2023 |
Source | Reapplix |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | 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 | |
Sweden | Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic | Ängelholm | |
Sweden | Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic | Lund |
Lead Sponsor | Collaborator |
---|---|
Reapplix |
Denmark, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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