Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers

Study Overview
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Brief Summary
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Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.

Official Title
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Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers

Conditions
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Venous Ulcer, Infection

Intervention / Treatment
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* Device: Restore Calcium Alginate Dressing
* Device: AquaCel Ag Wound Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is 18 years or older; male or female. Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux. Has a venous ulcer with a wound area between 5 cm2 - 40 cm2. Has an ankle brachial index (ABI) >0.8. Has a venous ulcer with duration less than 24 months. Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present: Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation Is currently using Profore as their standard of care. Has not received antibiotics for 6 weeks prior to enrollment. Exclusion Criteria Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver). Is currently on antibiotics. Has a negative venous duplex. Is unable to tolerate 4 layer compression. Is unable to continue contact with the investigator for a period of at least two weeks. Is unwilling or unable to comply with the study protocol.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restore Calcium Alginate Dressing Silver<br>Restore Calcium Alginate Dressing Silver under compression wrap | Device: Restore Calcium Alginate Dressing<br>* Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.<br>|
| Active Comparator: Aquacel Ag Wound Dressing<br>Aquacel Ag Wound Dressing under compression wrap | Device: AquaCel Ag Wound Dressing<br>* Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. |  | Observations will be collected over 6 weeks for a total of 7 visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective is to obtain photographic documentation of the venous leg ulcers during the course of the study. |  | Observations will be collected over 6 weeks in a total of 7 visits. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leg ulcer, infection, closure, wound dressings