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

Phase 2

• Conditions: Foot Ulcer; Diabetes
• Interventions: Device: KC-002; Other: Conventional Wound Therapy

• Registration Number: NCT00330265
• Lead Sponsor: KeraCure

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Study First Posted: 2006-05-26
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-25
• Last Update Posted: 2008-08-26
• Primary Completion: 2009-03
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	KC-002	KC-002
2	Conventional Wound Therapy	Conventional Wound Therapy

Primary Outcome Measures

Name	Time	Method
Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment	12 weeks

Trial Locations

Locations (21)

Doctor's Research Network; 🇺🇸 South Miami, Florida, United States

St. Vincent Health Center Wound Clinic; 🇺🇸 Erie, Pennsylvania, United States

North American Center for Limb Preservation; 🇺🇸 New Haven, Connecticut, United States

Pivotal Clinical Research; 🇺🇸 Souderton, Pennsylvania, United States

Warren General Hospital Wound Clinic; 🇺🇸 Warren, Pennsylvania, United States

Pharmaceutical Research Organization; 🇺🇸 Bountiful, Utah, United States

Medical Associates; 🇺🇸 Clinton, Iowa, United States

Institute for Advanced Wound Care at Baptist Medical Center South; 🇺🇸 Montgomery, Alabama, United States

Felix Sigal, DPM; 🇺🇸 Los Angeles, California, United States

San Antonio Podiatry Associates, PC; 🇺🇸 San Antonio, Texas, United States

Roy Kroeker, DPM; 🇺🇸 Fresno, California, United States

Bay Area Foot Care; 🇺🇸 San Francisco, California, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Martin Foot and Ankle; 🇺🇸 York, Pennsylvania, United States

Preston Family Building; 🇺🇸 Boston, Massachusetts, United States

Foot Healthcare Associates, PC; 🇺🇸 Livonia, Michigan, United States

Dixie Regional Medical Center's Wound Clinic; 🇺🇸 St. George, Utah, United States

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States

Georgetown University / Wound Healing Center; 🇺🇸 Washington, District of Columbia, United States

Central Washington Podiatry Service; 🇺🇸 Yakima, Washington, United States