Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

March 16, 2012 updated by: Harvest Technologies

Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic Ulcers

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Fayetteville, Alaska, United States, 72703
        • Washington Regional Medical Center
    • Florida
      • Orlando, Florida, United States, 32806
        • Lucerne Hospital
      • St. Petersburg, Florida, United States, 33708
        • Bay Pines V.A. Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Medical Center Hospital
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Traveling Medical Services
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Blair Medical Associates
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Hospital
    • Tennessee
      • Madison, Tennessee, United States, 37115
        • Tennessee Christian Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:chronic diabetic ulcer -

Exclusion Criteria:steroids, dialysis, vascular disease

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvest Technologies

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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