This trial is examining the effectiveness of autologous platelet-rich plasma (PRP) gel in the treatment of diabetic foot ulcers. The main outcome to be measured is the number of patients with complete wound closure. This study is being conducted in 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. Autologous PRP gel is a gel made out of the patients’ own platelets (blood component involved in clotting and healing).
The purpose of this study is to see if autologous PRP gel can help the healing of DFUs. The main outcome to be measured will be the proportion of patients whose ulcer completely heals in 16 weeks.
Who are they looking for?
This study is looking to recruit 192 patients with DFUs. Patients must have a HbA1c (average blood sugar over last 3 months) of less than or equal to 12%. Patients must have a full thickness ulcer for at least 4 weeks that is not infected and with an area of between 1.5-20cm2. The ulcer must not have any dead tissue or unhealthy tissue. Patients must have adequate blood circulation in their legs. Patients of childbearing age must agree to use contraception or abstain from sexual intercourse throughout the study.
Patients must not have ulcers that are infected, have exposed bone or bone infection, or have cellulitis or gangrene. Patients must not have undergone any other advanced ulcer treatment in the past 2 weeks other than standard ulcer care. Patients must not be breastfeeding or have active cancer and undergoing chemotherapy or a bleeding disorder. Patients must not have a deformity of the foot or any other skin lesions.
How will it work
For this study, patients will be randomly assigned to one of two groups. One group will be receiving autologous PRP gel. This will be applied to wounds such as leg ulcers, pressure ulcers, and DFUs. The other group will receive a saline (salt water) gel that will be applied to their wounds. Patients will be treated for 16 weeks.
The main outcome to be measured will be the number of patients with complete ulcer healing in 16 weeks from each group.
