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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes | Device: debridement, dressing, and APC | Not Applicable |
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 |
Actual Primary Completion Date : | September 2005 |
Actual Study Completion Date : | September 2005 |
Arm | Intervention/treatment |
---|---|
Experimental: APC Treatment
wound debridement and treatment with APC
|
Device: debridement, dressing, and APC
ebridement, dressing, and APC
|

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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

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
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 |
Principal Investigator: | Mark Iafrati, MD | Tufts Medical Ctr |
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 |