Status:
UNKNOWN
Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
Lead Sponsor:
KeraCure
Conditions:
Foot Ulcer
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 conv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00330265
Start Date
January 1 2006
End Date
September 1 2009
Last Update
August 26 2008
Active Locations (21)
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1
Institute for Advanced Wound Care at Baptist Medical Center South
Montgomery, Alabama, United States, 36111
2
HOPE Research Institute
Phoenix, Arizona, United States, 85050
3
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
4
Roy Kroeker, DPM
Fresno, California, United States, 93710