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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-02-28

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.

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Detailed Description

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Conditions

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Venous Ulcer Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Restore Calcium Alginate Dressing Silver

Restore Calcium Alginate Dressing Silver under compression wrap

Group Type EXPERIMENTAL

Restore Calcium Alginate Dressing

Intervention Type DEVICE

Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.

Aquacel Ag Wound Dressing

Aquacel Ag Wound Dressing under compression wrap

Group Type ACTIVE_COMPARATOR

AquaCel Ag Wound Dressing

Intervention Type DEVICE

Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.

Interventions

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Restore Calcium Alginate Dressing

Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.

Intervention Type DEVICE

AquaCel Ag Wound Dressing

Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Is 18 years or older; male or female.
2. Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux.
3. Has a venous ulcer with a wound area between 5 cm2 - 40 cm2.
4. Has an ankle brachial index (ABI) \>0.8.
5. Has a venous ulcer with duration less than 24 months.
6. 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
7. Is currently using Profore as their standard of care.
8. Has not received antibiotics for 6 weeks prior to enrollment.

Exclusion Criteria

1. Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid \[carboxymethylceullose\], silver).
2. Is currently on antibiotics.
3. Has a negative venous duplex.
4. Is unable to tolerate 4 layer compression.
5. Is unable to continue contact with the investigator for a period of at least two weeks.
6. Is unwilling or unable to comply with the study protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No