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

February 12, 2013 updated by: Hollister Wound Care LLC
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • St. Petersburg, Florida, United States, 33707
        • Palms of Pasadena Hospital
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
    • New Jersey
      • Holmdel, New Jersey, United States, 07733
        • Bayshore Community Hospital
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
        • Wound Institute & Research Center
    • Washington
      • Bellevue, Washington, United States, 98004
        • Lake Washington Vascular Surgeons

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Observations will be collected over 6 weeks for a total of 7 visits
Observations will be collected over 6 weeks for a total of 7 visits

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hollister Wound Care LLC

Investigators

  • Study Director: Rita Kaurs, MSHSA MT NMT, Hollister Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 15, 2011

First Posted (Estimate)

July 18, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4835-W

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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