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 because the information has not been verified recently.
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
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

Contacts
Contact: M Meek 866-537-2287 clinicaltrial@keracure.com

Locations
United States, Alabama
Institute for Advanced Wound Care at Baptist Medical Center South Recruiting
Montgomery, Alabama, United States, 36111
Contact    334-286-3444      
United States, Arizona
HOPE Research Institute Recruiting
Phoenix, Arizona, United States, 85050
Contact    602-274-4100      
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact    520-792-1450      
United States, California
Roy Kroeker, DPM Recruiting
Fresno, California, United States, 93710
Contact    559-436-8162      
Felix Sigal, DPM Recruiting
Los Angeles, California, United States, 90010
Contact    888-860-4325      
Bay Area Foot Care Recruiting
San Francisco, California, United States, 94115
Contact    415-292-0638      
United States, Connecticut
North American Center for Limb Preservation Recruiting
New Haven, Connecticut, United States, 06515
Contact    203-397-0624      
United States, District of Columbia
Georgetown University / Wound Healing Center Recruiting
Washington, District of Columbia, United States, 20007
Contact    202-444-1784      
United States, Florida
Doctor's Research Network Recruiting
South Miami, Florida, United States, 33143
Contact    305-662-1444      
United States, Iowa
Medical Associates Recruiting
Clinton, Iowa, United States, 52732
Contact    563-519-1871      
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact    410-601-5106      
United States, Massachusetts
Preston Family Building Recruiting
Boston, Massachusetts, United States, 02118
Contact    617-414-6840      
United States, Michigan
Foot Healthcare Associates, PC Recruiting
Livonia, Michigan, United States, 48152
Contact    734-542-9305      
United States, Pennsylvania
St. Vincent Health Center Wound Clinic Recruiting
Erie, Pennsylvania, United States, 16444
Contact    814-452-7878      
Pivotal Clinical Research Recruiting
Souderton, Pennsylvania, United States, 18964
Contact    215-723-7121      
Warren General Hospital Wound Clinic Recruiting
Warren, Pennsylvania, United States, 16365
Contact    814-723-3300 ext 2752      
Martin Foot and Ankle Recruiting
York, Pennsylvania, United States, 17403
Contact    717-718-0216      
United States, Texas
San Antonio Podiatry Associates, PC Recruiting
San Antonio, Texas, United States, 78229
Contact    210-949-0807      
United States, Utah
Pharmaceutical Research Organization Recruiting
Bountiful, Utah, United States, 84010
Contact    801-294-9911      
Dixie Regional Medical Center's Wound Clinic Recruiting
St. George, Utah, United States, 84770
Contact    435-688-5281      
United States, Washington
Central Washington Podiatry Service Recruiting
Yakima, Washington, United States, 98902
Contact    509-248-2900      
Sponsors and Collaborators
KeraCure
  More Information

No publications provided

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
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 26, 2014