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

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Hollister Wound Care LLC
ClinicalTrials.gov Identifier:
NCT01396304
First received: July 14, 2011
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Venous Ulcer
Infection
Device: Restore Calcium Alginate Dressing
Device: AquaCel Ag Wound Dressing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Hollister Wound Care LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396304

Locations
United States, Florida
Palms of Pasadena Hospital
St. Petersburg, Florida, United States, 33707
United States, Louisiana
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, New Jersey
Bayshore Community Hospital
Holmdel, New Jersey, United States, 07733
United States, Pennsylvania
Wound Institute & Research Center
Dunmore, Pennsylvania, United States, 18512
United States, Washington
Lake Washington Vascular Surgeons
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Hollister Wound Care LLC
Investigators
Study Director: Rita Kaurs, MSHSA MT NMT Hollister Incorporated
  More Information

No publications provided

Responsible Party: Hollister Wound Care LLC
ClinicalTrials.gov Identifier: NCT01396304     History of Changes
Other Study ID Numbers: 4835-W
Study First Received: July 14, 2011
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Hollister Wound Care LLC:
leg ulcer
infection
closure
wound dressings

Additional relevant MeSH terms:
Infection
Leg Ulcer
Ulcer
Varicose Ulcer
Cardiovascular Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases
Alginic acid
Calcium, Dietary
Bone Density Conservation Agents
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014