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

Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers (KC-002PT)
This study is currently recruiting participants.
Verified by KeraCure, August 2008
Sponsored by: KeraCure

Information provided by: KeraCure
ClinicalTrials.gov Identifier: NCT00330265

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 II

MedlinePlus related topics: Diabetes Diabetic Foot Foot Health
Drug Information available for: Sodium chloride
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
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

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
1: Experimental
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

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
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact 520-792-1450
HOPE Research Institute Recruiting
Phoenix, Arizona, United States, 85050
Contact 602-274-4100
United States, California
Bay Area Foot Care Recruiting
San Francisco, California, United States, 94115
Contact 415-292-0638
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
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
Warren General Hospital Wound Clinic Recruiting
Warren, Pennsylvania, United States, 16365
Contact 814-723-3300 ext 2752
Pivotal Clinical Research Recruiting
Souderton, Pennsylvania, United States, 18964
Contact 215-723-7121
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
Dixie Regional Medical Center's Wound Clinic Recruiting
St. George, Utah, United States, 84770
Contact 435-688-5281
Pharmaceutical Research Organization Recruiting
Bountiful, Utah, United States, 84010
Contact 801-294-9911
United States, Washington
Central Washington Podiatry Service Recruiting
Yakima, Washington, United States, 98902
Contact 509-248-2900

Sponsors and Collaborators
KeraCure
More Information

Responsible Party:KeraCure ( KeraCure )
Study ID Numbers:NCT 20051320
First Received:May 24, 2006
Last Updated:August 25, 2008
ClinicalTrials.gov Identifier:NCT00330265 [history]
Health Authority:United States: Food and Drug Administration

Study placed in the following topic categories:
Foot Ulcer
Skin Diseases
Diabetic Neuropathies
Ulcer
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Foot Diseases
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases