Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
KC-002PT
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
1 other identifier
interventional
300
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2006
Typical duration for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 24, 2006
CompletedFirst Posted
Study publicly available on registry
May 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedAugust 26, 2008
August 1, 2008
3.2 years
May 24, 2006
August 25, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment
12 weeks
Study Arms (2)
1
EXPERIMENTALKC-002
2
OTHERConventional Wound Therapy
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KeraCurelead
Study Sites (21)
Institute for Advanced Wound Care at Baptist Medical Center South
Montgomery, Alabama, 36111, United States
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
Roy Kroeker, DPM
Fresno, California, 93710, United States
Felix Sigal, DPM
Los Angeles, California, 90010, United States
Bay Area Foot Care
San Francisco, California, 94115, United States
North American Center for Limb Preservation
New Haven, Connecticut, 06515, United States
Georgetown University / Wound Healing Center
Washington D.C., District of Columbia, 20007, United States
Doctor's Research Network
South Miami, Florida, 33143, United States
Medical Associates
Clinton, Iowa, 52732, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Preston Family Building
Boston, Massachusetts, 02118, United States
Foot Healthcare Associates, PC
Livonia, Michigan, 48152, United States
St. Vincent Health Center Wound Clinic
Erie, Pennsylvania, 16444, United States
Pivotal Clinical Research
Souderton, Pennsylvania, 18964, United States
Warren General Hospital Wound Clinic
Warren, Pennsylvania, 16365, United States
Martin Foot and Ankle
York, Pennsylvania, 17403, United States
San Antonio Podiatry Associates, PC
San Antonio, Texas, 78229, United States
Pharmaceutical Research Organization
Bountiful, Utah, 84010, United States
Dixie Regional Medical Center's Wound Clinic
St. George, Utah, 84770, United States
Central Washington Podiatry Service
Yakima, Washington, 98902, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 24, 2006
First Posted
May 26, 2006
Study Start
January 1, 2006
Primary Completion
March 1, 2009
Study Completion
September 1, 2009
Last Updated
August 26, 2008
Record last verified: 2008-08