A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00338702|
Recruitment Status : Withdrawn (Industry support and funding not forthcoming)
First Posted : June 20, 2006
Last Update Posted : May 21, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Procedure: Autologous Platelet Gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2008|
|Primary Completion Date :||October 2009|
|Estimated Study Completion Date :||October 2009|
- Time to 25% percent closure at 6 weeks
- Time to 50% closure at 12 weeks
- Time to definitive closure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|