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Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers (KC-002PT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by KeraCure.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
KeraCure
ClinicalTrials.gov Identifier:
NCT00330265
First received: May 24, 2006
Last updated: August 25, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Foot Ulcer
Diabetes
Device: KC-002
Other: Conventional Wound Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by KeraCure:

Primary Outcome Measures:
  • Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
KC-002
Device: 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
Other: Conventional Wound Therapy
Normal Saline Dressings

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330265

Locations
United States, Alabama
Institute for Advanced Wound Care at Baptist Medical Center South
Montgomery, Alabama, United States, 36111
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
United States, California
Roy Kroeker, DPM
Fresno, California, United States, 93710
Felix Sigal, DPM
Los Angeles, California, United States, 90010
Bay Area Foot Care
San Francisco, California, United States, 94115
United States, Connecticut
North American Center for Limb Preservation
New Haven, Connecticut, United States, 06515
United States, District of Columbia
Georgetown University / Wound Healing Center
Washington, District of Columbia, United States, 20007
United States, Florida
Doctor's Research Network
South Miami, Florida, United States, 33143
United States, Iowa
Medical Associates
Clinton, Iowa, United States, 52732
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Preston Family Building
Boston, Massachusetts, United States, 02118
United States, Michigan
Foot Healthcare Associates, PC
Livonia, Michigan, United States, 48152
United States, Pennsylvania
St. Vincent Health Center Wound Clinic
Erie, Pennsylvania, United States, 16444
Pivotal Clinical Research
Souderton, Pennsylvania, United States, 18964
Warren General Hospital Wound Clinic
Warren, Pennsylvania, United States, 16365
Martin Foot and Ankle
York, Pennsylvania, United States, 17403
United States, Texas
San Antonio Podiatry Associates, PC
San Antonio, Texas, United States, 78229
United States, Utah
Pharmaceutical Research Organization
Bountiful, Utah, United States, 84010
Dixie Regional Medical Center's Wound Clinic
St. George, Utah, United States, 84770
United States, Washington
Central Washington Podiatry Service
Yakima, Washington, United States, 98902
Sponsors and Collaborators
KeraCure
  More Information

Responsible Party: KeraCure
ClinicalTrials.gov Identifier: NCT00330265     History of Changes
Other Study ID Numbers: NCT 20051320 
Study First Received: May 24, 2006
Last Updated: August 25, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases

ClinicalTrials.gov processed this record on December 07, 2016