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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-04-30

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.

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Detailed Description

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Conditions

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Wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

COPA AMD (note: name is not an acronym)

Intervention Type DEVICE

Foam dressing impregnated with Polyhexamethylene Biguanide

Arm 2

Group Type ACTIVE_COMPARATOR

COPA (note: name is not an acronym)

Intervention Type DEVICE

Regular foam dressing without PHMB

Interventions

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COPA AMD (note: name is not an acronym)

Foam dressing impregnated with Polyhexamethylene Biguanide

Intervention Type DEVICE

COPA (note: name is not an acronym)

Regular foam dressing without PHMB

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No