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AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01084577
First Posted: March 10, 2010
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ConvaTec Inc.
  Purpose
A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.

Condition Intervention Phase
Leg Ulcer Device: AQUACEL® Ag Device: Urgotul® Silver Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-centre, Randomized, Open-label, Parallel, Comparative Study to Evaluate Effects of AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Wound area reduction from baseline (relative) [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Wound closure [ Time Frame: 8 weeks ]
  • Clinical evolution of the wound [ Time Frame: 8 weeks ]
    presence of each of the 5 selected clinical signs

  • Tolerance [ Time Frame: 8 weeks ]
    occurrence of local adverse events


Estimated Enrollment: 266
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Urgotul® Silver
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
Device: Urgotul® Silver
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
Active Comparator: AQUACEL® Ag
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
Device: AQUACEL® Ag
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects over 18 years, willing and able to provide written informed consent.
  • Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater.
  • Subjects who have a venous leg ulcer (i.e. CEAP classification of C6), with duration less than 24 months and size ranging between 5 cm2-40 cm2 .
  • Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs: pain between 2 dressing changes, perilesional skin erythema, oedema, foul odour, and heavy exudation.
  • Subjects agree to wear compression therapy daily in combination with the trial dressing.

Exclusion Criteria:

  • Subjects with a history of skin sensitivity to any of the components of the study product.
  • Subjects who have had current local or systemic antibiotics in the week prior to inclusion.
  • Subjects whose leg ulcers are clinically infected or erysipelas, malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
  • Subjects who have a progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents or high dose corticosteroids.
  • Subjects who have participated in a clinical study within the past 3 months.
  • Subjects who are pregnant or breastfeeding (in accordance with the Urgotul® Silver package insert).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084577


  Show 56 Study Locations
Sponsors and Collaborators
ConvaTec Inc.
Investigators
Study Director: Dheerendra Kommala, MD ConvaTec Inc.
  More Information

Responsible Party: Dheerendra Kommala, MD, Convatec Inc.
ClinicalTrials.gov Identifier: NCT01084577     History of Changes
Other Study ID Numbers: CW-0142-09-U354
First Submitted: March 9, 2010
First Posted: March 10, 2010
Last Update Posted: February 21, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents