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

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

ChemIDplus related topics:

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
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

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	KeraCure
Information provided by:	KeraCure
ClinicalTrials.gov Identifier:	NCT00330265