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Completed

NCT Number: NCT01497210

EASH Dressing on Chronic Venous Leg Ulcers

The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mikomed, Lodz, Poland

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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 and size ranging between 5 cm2-40 cm2.
  • Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs of infection: pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour (foul odour), and heavy exudate.
  • Subjects who 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 with the exception of wounds that are considered to be 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

EASH dressing

Device

Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.

Primary outcomes

  1. Safety

    Time frame: All 8 weeks

    Nature and frequency of adverse events.

Secondary outcomes

  1. Ulcer Improvement (wound bed)

    Time frame: Baseline, week 4 and week 8

  2. Ulcer Improvement (peri-ulcer)

    Time frame: Baseline, week 4 and week 8 or final visit

  3. Healing

    Time frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit

    Reduction in ulcer area

  4. Healing

    Time frame: 8 weeks or final visit

    Number of subjects healed

  5. Healing

    Time frame: 8 weeks or final visit

    Time to healing

  6. Ulcer pain

    Time frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit

  7. Comfort

    Time frame: Weekly for 4 weeks then biweekly for 4 weeks

  8. Ease of use

    Time frame: Weekly for 4 weeks then biweekly for 4 weeks

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study title

A Prospective, Multi-centre, Non-comparative Study to Evaluate the Safety and Preliminary Performance of the EASH Dressing on Chronic Venous Leg Ulcers

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 22, 2011
Registry last updated
Apr 25, 2012

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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