Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing

Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing

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 foam dressing compared to regular foam dressing in subjects with chronic wounds.

Inclusion Criteria:

• 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 Criteria:

• 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