Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
NCT ID: NCT00330265
Last Updated: 2008-08-26
Study Results
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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UNKNOWN
PHASE2
300 participants
INTERVENTIONAL
2006-01-31
2009-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
KC-002
KC-002
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.
2
Conventional Wound Therapy
Conventional Wound Therapy
Normal Saline Dressings
Interventions
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KC-002
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.
Conventional Wound Therapy
Normal Saline Dressings
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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KeraCure
INDUSTRY
Responsible Party
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KeraCure
Locations
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Institute for Advanced Wound Care at Baptist Medical Center South
Montgomery, Alabama, United States
HOPE Research Institute
Phoenix, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Roy Kroeker, DPM
Fresno, California, United States
Felix Sigal, DPM
Los Angeles, California, United States
Bay Area Foot Care
San Francisco, California, United States
North American Center for Limb Preservation
New Haven, Connecticut, United States
Georgetown University / Wound Healing Center
Washington D.C., District of Columbia, United States
Doctor's Research Network
South Miami, Florida, United States
Medical Associates
Clinton, Iowa, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Preston Family Building
Boston, Massachusetts, United States
Foot Healthcare Associates, PC
Livonia, Michigan, United States
St. Vincent Health Center Wound Clinic
Erie, Pennsylvania, United States
Pivotal Clinical Research
Souderton, Pennsylvania, United States
Warren General Hospital Wound Clinic
Warren, Pennsylvania, United States
Martin Foot and Ankle
York, Pennsylvania, United States
San Antonio Podiatry Associates, PC
San Antonio, Texas, United States
Pharmaceutical Research Organization
Bountiful, Utah, United States
Dixie Regional Medical Center's Wound Clinic
St. George, Utah, United States
Central Washington Podiatry Service
Yakima, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCT 20051320
Identifier Type: -
Identifier Source: org_study_id