Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

NCT ID: NCT00215735

Last Updated: 2012-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Study Groups

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APC Treatment

wound debridement and treatment with APC

Group Type EXPERIMENTAL

debridement, dressing, and APC

Intervention Type DEVICE

ebridement, dressing, and APC

Interventions

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debridement, dressing, and APC

ebridement, dressing, and APC

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvest Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Iafrati, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Ctr

Locations

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Washington Regional Medical Center

Fayetteville, Alaska, United States

Site Status

Lucerne Hospital

Orlando, Florida, United States

Site Status

Bay Pines V.A. Medical Center

St. Petersburg, Florida, United States

Site Status

New England Medical Center Hospital

Boston, Massachusetts, United States

Site Status

Traveling Medical Services

Southfield, Michigan, United States

Site Status

Blair Medical Associates

Altoona, Pennsylvania, United States

Site Status

Roger Williams Hospital

Providence, Rhode Island, United States

Site Status

Tennessee Christian Hospital

Madison, Tennessee, United States

Site Status

St. Luke's Medical Ctr

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2003-1

Identifier Type: -

Identifier Source: org_study_id

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