Effect of Platelet Concentrate in Treatment of Diabetic Ulcers
This study has been terminated.
(inconclusive results, market feasiblity)
Sponsor:
Harvest Technologies
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
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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
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 May 19, 2013