Diabetes Clinical Trial
— KC-002PTOfficial 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
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | September 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Preston Family Building | Boston | Massachusetts |
United States | Pharmaceutical Research Organization | Bountiful | Utah |
United States | Medical Associates | Clinton | Iowa |
United States | St. Vincent Health Center Wound Clinic | Erie | Pennsylvania |
United States | Roy Kroeker, DPM | Fresno | California |
United States | Foot Healthcare Associates, PC | Livonia | Michigan |
United States | Felix Sigal, DPM | Los Angeles | California |
United States | Institute for Advanced Wound Care at Baptist Medical Center South | Montgomery | Alabama |
United States | North American Center for Limb Preservation | New Haven | Connecticut |
United States | HOPE Research Institute | Phoenix | Arizona |
United States | San Antonio Podiatry Associates, PC | San Antonio | Texas |
United States | Bay Area Foot Care | San Francisco | California |
United States | Pivotal Clinical Research | Souderton | Pennsylvania |
United States | Doctor's Research Network | South Miami | Florida |
United States | Dixie Regional Medical Center's Wound Clinic | St. George | Utah |
United States | Southern Arizona VA Health Care System | Tucson | Arizona |
United States | Warren General Hospital Wound Clinic | Warren | Pennsylvania |
United States | Georgetown University / Wound Healing Center | Washington | District of Columbia |
United States | Central Washington Podiatry Service | Yakima | Washington |
United States | Martin Foot and Ankle | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
KeraCure |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment | 12 weeks | No |
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