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

This study has been completed.
Sponsor:
Information provided by:
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01084577
First received: March 9, 2010
Last updated: February 17, 2011
Last verified: February 2011
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Wound area reduction from baseline (relative) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wound closure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical evolution of the wound [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    presence of each of the 5 selected clinical signs

  • Tolerance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084577

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

No publications provided

Responsible Party: Dheerendra Kommala, MD, Convatec Inc.
ClinicalTrials.gov Identifier: NCT01084577     History of Changes
Other Study ID Numbers: CW-0142-09-U354
Study First Received: March 9, 2010
Last Updated: February 17, 2011
Health Authority: United Kingdom: Research Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Ethics Committee
Germany: Ethics Commission
Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013