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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wounds

Intervention / Treatment
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* Device: COPA AMD (note: name is not an acronym)
* Device: COPA (note: name is not an acronym)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Device: COPA AMD (note: name is not an acronym)<br>* Foam dressing impregnated with Polyhexamethylene Biguanide<br>|
| Active Comparator: Arm 2<br> | Device: COPA (note: name is not an acronym)<br>* Regular foam dressing without PHMB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups |  | 5 weeks | 
| Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0. | At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0. | Weeks 0 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 5 weeks |