MedTrace Logo

A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers

NCT00338702 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

PROCEDURE

Autologous Platelet Gel

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • James L Mahoney, MD, FRCSC · Unity Health Toronto

  • Timothy R Daniels, MD, FRCSC · St. Michael Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00338702 on ClinicalTrials.gov