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

Status unconfirmed · Phase 2

Conditions studied: Foot Ulcer, Diabetes

In brief

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.

Key facts

Study ID

NCT00330265

Run by

KeraCure

People needed

300

Starts

2006-01-01

Expected to finish

2009-09-01

Last updated by the study team

2008-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Institute for Advanced Wound Care at Baptist Medical Center South — Montgomery, Alabama, United States (enrolling)
• HOPE Research Institute — Phoenix, Arizona, United States (enrolling)
• Southern Arizona VA Health Care System — Tucson, Arizona, United States (enrolling)
• Roy Kroeker, DPM — Fresno, California, United States (enrolling)
• Felix Sigal, DPM — Los Angeles, California, United States (enrolling)
• Bay Area Foot Care — San Francisco, California, United States (enrolling)
• North American Center for Limb Preservation — New Haven, Connecticut, United States (enrolling)
• Georgetown University / Wound Healing Center — Washington D.C., District of Columbia, United States (enrolling)
• Doctor's Research Network — South Miami, Florida, United States (enrolling)
• Medical Associates — Clinton, Iowa, United States (enrolling)
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States (enrolling)
• Preston Family Building — Boston, Massachusetts, United States (enrolling)
• Foot Healthcare Associates, PC — Livonia, Michigan, United States (enrolling)
• St. Vincent Health Center Wound Clinic — Erie, Pennsylvania, United States (enrolling)
• Pivotal Clinical Research — Souderton, Pennsylvania, United States (enrolling)
• Warren General Hospital Wound Clinic — Warren, Pennsylvania, United States (enrolling)
• Martin Foot and Ankle — York, Pennsylvania, United States (enrolling)
• San Antonio Podiatry Associates, PC — San Antonio, Texas, United States (enrolling)
• Pharmaceutical Research Organization — Bountiful, Utah, United States (enrolling)
• Dixie Regional Medical Center's Wound Clinic — St. George, Utah, United States (enrolling)
• Central Washington Podiatry Service — Yakima, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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