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Completed

NCT Number: NCT01084577

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.

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Key information

Conditions

Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arhus Universitets Hospital (#47), Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Aquacel® Ag

Device

AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.

Urgotul® Silver

Device

Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.

Primary outcomes

  1. Wound area reduction from baseline (relative)

    Time frame: 8 weeks

Secondary outcomes

  1. Wound closure

    Time frame: 8 weeks

  2. Clinical evolution of the wound

    Time frame: 8 weeks

    presence of each of the 5 selected clinical signs

  3. Tolerance

    Time frame: 8 weeks

    occurrence of local adverse events

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2010
Registry last updated
Feb 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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