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Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

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ClinicalTrials.gov Identifier: NCT00215735
Recruitment Status : Terminated (inconclusive results, market feasiblity)
First Posted : September 22, 2005
Last Update Posted : March 20, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds

Condition or disease Intervention/treatment
Diabetes Device: debridement, 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.

Study Design

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : June 2004
Primary Completion Date : September 2005
Study Completion Date : September 2005
Arms and Interventions

Arm Intervention/treatment
Experimental: APC Treatment
wound debridement and treatment with APC
Device: debridement, dressing, and APC
ebridement, dressing, and APC


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:chronic diabetic ulcer -

Exclusion Criteria:steroids, dialysis, vascular disease

Contacts and Locations

Information from the National Library of Medicine

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): 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

Responsible Party: Harvest Technologies
ClinicalTrials.gov Identifier: NCT00215735     History of Changes
Other Study ID Numbers: 2003-1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Keywords provided by Harvest Technologies:
diabetes
Ulcer
APC