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OpenTrials
Completed

NCT Number: NCT01591434

Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic wounds such as venous leg ulcers.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dermatologische Gemeinschaftspraxis, Freiburg im Breisgau, Germany

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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 1) with duration less than 24 months
  • Subjects whose ulcer is no smaller than 2cms in any one direction
  • Subjects whose ulcer is no greater than 11cm in any one direction (measured by longest length and widest width)
  • Subjects' whose index leg ulcer has a moderate to heavy level of exudate.
  • Subjects whose index (study) leg is currently being treated with compression therapy and whose leg oedema is under control
  • Subjects who are willing and able to comply with the requirements of the clinical investigation plan in relation to the dressing/compression regime and the ability to attend dressing changes as required.

Exclusion criteria

  • Subjects with a history of skin sensitivity to any of the components of the study dressings (AQUACEL® Extra™, AQUACEL®, & DuoDERM™ Extra Thin)
  • Subjects whose wounds are considered clinically infected at baseline
  • Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
  • Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents
  • Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
  • Subjects who have participated in a clinical study within the past month.

Treatment and study plan

AQUACEL®

Device

Dressing to be changed as clinically needed or at least every seven days.

AQUACEL® Extra™

Device

Dressing to be changed as clinically needed or at least every seven days.

Primary outcomes

  1. Wear Time

    Time frame: 4 weeks

    frequency of dressing changes

  2. Wear Time

    Time frame: 4 weeks

    Reason for dressing changes

  3. % of dressings achieving a 7 day wear time

    Time frame: 4 weeks

  4. Time to achieve a 7 day wear time

    Time frame: 4 weeks

  5. Condition of the peri-ulcer skin

    Time frame: 4 weeks

    Improvement from baseline in the condition of the peri-ulcer skin

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study title

An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 4, 2012
Registry last updated
Jul 30, 2013

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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