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

PHASE2UnknownINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

March 31, 2009

Study Completion Date

September 30, 2009

Conditions
Foot UlcerDiabetes
Interventions
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.

OTHER

Conventional Wound Therapy

Normal Saline Dressings

Trial Locations (21)

16365

RECRUITING

Warren General Hospital Wound Clinic, Warren

16444

RECRUITING

St. Vincent Health Center Wound Clinic, Erie

17403

RECRUITING

Martin Foot and Ankle, York

18964

RECRUITING

Pivotal Clinical Research, Souderton

20007

RECRUITING

Georgetown University / Wound Healing Center, Washington D.C.

21215

RECRUITING

Sinai Hospital of Baltimore, Baltimore

33143

RECRUITING

Doctor's Research Network, South Miami

36111

RECRUITING

Institute for Advanced Wound Care at Baptist Medical Center South, Montgomery

48152

RECRUITING

Foot Healthcare Associates, PC, Livonia

52732

RECRUITING

Medical Associates, Clinton

78229

RECRUITING

San Antonio Podiatry Associates, PC, San Antonio

84010

RECRUITING

Pharmaceutical Research Organization, Bountiful

84770

RECRUITING

Dixie Regional Medical Center's Wound Clinic, St. George

85050

RECRUITING

HOPE Research Institute, Phoenix

85723

RECRUITING

Southern Arizona VA Health Care System, Tucson

90010

RECRUITING

Felix Sigal, DPM, Los Angeles

93710

RECRUITING

Roy Kroeker, DPM, Fresno

94115

RECRUITING

Bay Area Foot Care, San Francisco

98902

RECRUITING

Central Washington Podiatry Service, Yakima

06515

RECRUITING

North American Center for Limb Preservation, New Haven

02118

RECRUITING

Preston Family Building, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

KeraCure

INDUSTRY