EASH Dressing on Chronic Venous Leg Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01497210
Recruitment Status : Completed
First Posted : December 22, 2011
Last Update Posted : April 25, 2012
Information provided by (Responsible Party):
ConvaTec Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leg Ulcer Device: EASH dressing Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-centre, Non-comparative Study to Evaluate the Safety and Preliminary Performance of the EASH Dressing on Chronic Venous Leg Ulcers
Study Start Date : November 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: EASH Device: EASH dressing
Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.

Primary Outcome Measures :
  1. Safety [ Time Frame: All 8 weeks ]
    Nature and frequency of adverse events.

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01497210

Lodz, Poland
Cross Medica
Warszawa, Poland
Zabrze, Poland
United Kingdom
Wound Healing Research Unit
Heath Park, Cardiff, United Kingdom, CF14 4XN
Axbridge & Wedmore Medical Practice
Axbridge, Somerset, United Kingdom, BS26 2BJ
Arrowe Park Hospital
Upton, Wirral, United Kingdom, CH49 5PE
Sponsors and Collaborators
ConvaTec Inc.
Principal Investigator: Keith Harding Wound Healing Research Unit, Cardiff University

Responsible Party: ConvaTec Inc. Identifier: NCT01497210     History of Changes
Other Study ID Numbers: CW-0205-11-U356
First Posted: December 22, 2011    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases