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Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

This study has been terminated.
(inconclusive results, market feasiblity)
Information provided by (Responsible Party):
Harvest Technologies Identifier:
First received: September 14, 2005
Last updated: March 16, 2012
Last verified: March 2012
Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds

Condition Intervention
Diabetes Device: debridement, dressing, and APC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Official Title: Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic Ulcers

Further study details as provided by Harvest Technologies:

Study Start Date: June 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APC Treatment
wound debridement and treatment with APC
Device: debridement, dressing, and APC
ebridement, dressing, and APC

Detailed Description:
The treatment of a diabetic wound with APC and thrombinhas the potential to accelerate the re-epithial process when compared with usual care. The study is a prospective, randomized, blinded, multicenter clinical evaluation.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:chronic diabetic ulcer -

Exclusion Criteria:steroids, dialysis, vascular disease

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00215735

United States, Alaska
Washington Regional Medical Center
Fayetteville, Alaska, United States, 72703
United States, Florida
Lucerne Hospital
Orlando, Florida, United States, 32806
Bay Pines V.A. Medical Center
St. Petersburg, Florida, United States, 33708
United States, Massachusetts
New England Medical Center Hospital
Boston, Massachusetts, United States, 02111
United States, Michigan
Traveling Medical Services
Southfield, Michigan, United States, 48075
United States, Pennsylvania
Blair Medical Associates
Altoona, Pennsylvania, United States, 16602
United States, Rhode Island
Roger Williams Hospital
Providence, Rhode Island, United States, 02908
United States, Tennessee
Tennessee Christian Hospital
Madison, Tennessee, United States, 37115
United States, Wisconsin
St. Luke's Medical Ctr
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Harvest Technologies
Principal Investigator: Mark Iafrati, MD Tufts Medical Ctr
  More Information

Responsible Party: Harvest Technologies Identifier: NCT00215735     History of Changes
Other Study ID Numbers: 2003-1
Study First Received: September 14, 2005
Last Updated: March 16, 2012

Keywords provided by Harvest Technologies:
APC processed this record on September 19, 2017