This trial is examining the safety and effectiveness of new dressing ALLO-ASC-SHEET in the treatment of diabetic foot ulcers. The main outcome to be measured will be the number of patients with completely healed ulcers. This trial is recruiting in California, the United States.
The details
Diabetic foot ulcers (DFU) are a common complication of diabetes. DFUs are very difficult to heal and can result in pain, infection, amputation, and disability. Therefore, treating DFUs is very important. ALLO-ASC-SHEET is a new dressing that uses a patients’ own cells to promote healing.
This study is examining the safety and effectiveness of ALLO-ASC-SHEET in the treatment of DFU. The main outcome to be measured will be the number of patients whose ulcers heal completely.
Who are they looking for?
This study is recruiting 44 patients. Patients must have a DFU for longer than 4 weeks and be located in the instep, border or sole of the foot. The ulcer size must be between 1 and 15 cm2. The ulcer must not have any infection, dead tissue or be caused by something other than diabetes. Female patients must be willing to use effective contraception.
Patients must not have HIV, any active infections, or severe liver disease. They must not have a HbA1c of greater than 10% or blood sugar level after a meal of more than 350 mg/dl. Patients must not have an allergy to any cow proteins. Patients must not have had any cancer in the past 5 years and must not be currently enrolled in any other clinical study within 60 days or have undergone any wound treatments with growth factors or other biological therapies within the last 30 day. Patients must not be taking any steroids, immunosuppressive or cytotoxic medications.
How will it work
Patients will be randomly assigned to be treated with either ALLO-ASC-SHEET dressing or a hydrogel dressing without any patient cells. Patients will be treated for 12 weeks. The number of patients whose ulcers completely heal within the 12 weeks of treatment. Change in wound sizes will also be measured.
