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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

March 9, 2010
February 17, 2011
January 2010
January 2011   (final data collection date for primary outcome measure)
Wound area reduction from baseline (relative) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01084577 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Leg Ulcer
  • Device: AQUACEL® Ag
    AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
  • Device: Urgotul® Silver
    Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
  • Active Comparator: Urgotul® Silver
    Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
    Intervention: Device: Urgotul® Silver
  • Active Comparator: AQUACEL® Ag
    AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
    Intervention: Device: AQUACEL® Ag
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
January 2011
January 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Germany,   Poland,   United Kingdom
 
NCT01084577
CW-0142-09-U354
Not Provided
Dheerendra Kommala, MD, Convatec Inc.
ConvaTec Inc.
Not Provided
Study Director: Dheerendra Kommala, MD ConvaTec Inc.
ConvaTec Inc.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP