A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers
Foot ulcers represent a significant common complication in patients with diabetes. Wound healing is a challenge. Some wounds do not respond to the best practices in wound care. Considerable effort has been directed at therapies to improve the rate of healing.
There are a variety of growth factors which have been used to stimulate wound healing. Human platelets are an autologous source of growth factors which probably can stimulate healing. Autologous platelet gel (APG) is prepared by centrifugation of autologous human whole blood. APG is rich in platelet growth factors. This study will investigate the potential improvement in wound healing with this material in diabetic foot ulcers.
This study will compare the use of autologous platelet gel ( study group) and standard care ( control group) in the treatment of diabetic plantar forefoot ulcers. This study will also compare the cost and quality of life in the two groups.
Objectives of the study:
- To determine if topical APG (autologous platelet gel) is beneficial in the treatment of diabetic foot ulcers.
- To determine if it will result in a faster rate of wound healing.
- To determine if it will improve the quality of life in patients with diabetic foot ulcers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Time to 25% percent closure at 6 weeks
- Time to 50% closure at 12 weeks
- Time to definitive closure
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||October 2009|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338702
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator:||James L Mahoney, MD, FRCSC||St. Michael's Hospital, Toronto|
|Principal Investigator:||Timothy R Daniels, MD, FRCSC||St. Michael Hospital|