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NCT00215735 Clinical Trial

Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00215735
Other study ID # 2003-1
Secondary ID
Status Terminated
Phase N/A
First received September 14, 2005
Last updated March 16, 2012
Start date June 2004
Est. completion date September 2005

Study information
Verified date March 2012
Source Harvest Technologies
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds

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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date September 2005
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:chronic diabetic ulcer -

Exclusion Criteria:steroids, dialysis, vascular disease

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Device:
• debridement, dressing, and APC
ebridement, dressing, and APC

Locations
Country Name City State
United States Blair Medical Associates Altoona Pennsylvania
United States New England Medical Center Hospital Boston Massachusetts
United States Washington Regional Medical Center Fayetteville Alaska
United States Tennessee Christian Hospital Madison Tennessee
United States St. Luke's Medical Ctr Milwaukee Wisconsin
United States Lucerne Hospital Orlando Florida
United States Roger Williams Hospital Providence Rhode Island
United States Traveling Medical Services Southfield Michigan
United States Bay Pines V.A. Medical Center St. Petersburg Florida

Sponsors (1)
Lead Sponsor Collaborator
Harvest Technologies

Country where clinical trial is conducted

United States, 

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