Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

This study has been terminated.
(inconclusive results, market feasiblity)
Sponsor:
Information provided by (Responsible Party):
Harvest Technologies
ClinicalTrials.gov Identifier:
NCT00215735
First received: September 14, 2005
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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 Blind
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

Resource links provided by NLM:


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00215735

Locations
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
Investigators
Principal Investigator: Mark Iafrati, MD Tufts Medical Ctr
  More Information

No publications provided

Responsible Party: Harvest Technologies
ClinicalTrials.gov Identifier: NCT00215735     History of Changes
Other Study ID Numbers: 2003-1
Study First Received: September 14, 2005
Last Updated: March 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Harvest Technologies:
diabetes
Ulcer
APC

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014