Status:
COMPLETED
Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing
Lead Sponsor:
Tyco Healthcare Group
Conditions:
Wounds
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA AMD PHMB Impregnated f...
Eligibility Criteria
Inclusion
- subject is 18 to 85 years of age inclusive
- subject has a foot ulcer
- subject has a leg ulcer
- subject has an open wound of at 1.0 cm (2)
- subject has one of the following: Palpable pulse, ABI \> 0.56 or toe pressure \> 50 mmHg
- subject or legally authorized rep is able to understand and willing to give written informed consent
Exclusion
- subject has an allergy to Chlorhexidine Gluconate (CHG)
- subject has open wounds that in the opinion of the Principal Investigator do not have the ability to heal
- subject has current malignant disease or history of malignant disease in past 5 years
- subject has inability to comply with the study protocol and procedures
- subjects who require use of topical agents other than the impregnated or regular foam dressings dressings
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00618787
Start Date
February 1 2008
End Date
April 1 2009
Last Update
April 15 2010
Active Locations (2)
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1
Community Dermatology and Wound Healing Clinic
Mississauga, Ontario, Canada, L4Y 1A6
2
Women's College Hospital; Dermatology Daycare & Wound Healing Clinic
Toronto, Ontario, Canada, M5S 1B2