Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers



Status:Completed
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:January 2006
End Date:September 2009
Contact:M Meek
Email:clinicaltrial@keracure.com
Phone:866-537-2287

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A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes Versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers

The objective of this study is to determine the safety and effectiveness of a device (the
KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as
compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2
diabetes mellitus.

This is a prospective, randomized, multi-center, unmasked, controlled study. All patients
will receive care for the diabetic foot ulcer during the study.

Participation in the study is for 24 weeks.


Inclusion Criteria:

Participants included in the study must:

- Have Type 1 or Type 2 diabetes mellitus

- Have a diabetic foot ulcer on the bottom of the foot or heal which has been present
for three (3) weeks but less than two (2) years and is sufficient size to qualify for
the study

- Be able to visit the study doctor regularly for 24 weeks

Exclusion Criteria:

Participants may not be included if:

- The diabetic foot ulcer is infected

- They have poor circulation in their study foot

- Cannot or will not wear a special boot to take pressure off the study ulcer

- They have certain other diseases or laboratory values which are not within a
specified range
We found this trial at
21
sites
Los Angeles, California 90010
17
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Los Angeles, CA
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Baltimore, MD
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Boston, Massachusetts 02118
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Boston, MA
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Bountiful, Utah 84010
578
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Bountiful, UT
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Clinton, Iowa 52732
1598
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Clinton, IA
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Erie, Pennsylvania 16444
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Erie, PA
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Fresno, California 93710
214
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Fresno, CA
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Livonia, Michigan 48152
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Livonia, MI
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Montgomery, AL
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New Haven, Connecticut 06515
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New Haven, CT
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Phoenix, Arizona 85050
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Phoenix, AZ
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San Antonio, Texas 78229
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San Antonio, TX
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San Francisco, California 94115
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San Francisco, CA
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Souderton, Pennsylvania 18964
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Souderton, PA
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South Miami, Florida 33143
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South Miami, FL
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St. George, UT
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Tucson, AZ
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Warren, Pennsylvania 16365
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Warren, PA
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Washington, District of Columbia 20007
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Washington,
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Yakima, Washington 98902
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Yakima, WA
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York, Pennsylvania 17403
2293
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York, PA
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