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EASH Dressing on Chronic Venous Leg Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01497210
First received: December 20, 2011
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Leg Ulcer
 Device: EASH dressing
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: All 8 weeks ] [ Designated as safety issue: No ]
    Nature and frequency of adverse events.


Secondary Outcome Measures:
  • Ulcer Improvement (wound bed) [ Time Frame: Baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
  • Ulcer Improvement (peri-ulcer) [ Time Frame: Baseline, week 4 and week 8 or final visit ] [ Designated as safety issue: No ]
  • Healing [ Time Frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit ] [ Designated as safety issue: No ]
    Reduction in ulcer area

  • Healing [ Time Frame: 8 weeks or final visit ] [ Designated as safety issue: No ]
    Number of subjects healed

  • Healing [ Time Frame: 8 weeks or final visit ] [ Designated as safety issue: No ]
    Time to healing

  • Ulcer pain [ Time Frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit ] [ Designated as safety issue: No ]
  • Comfort [ Time Frame: Weekly for 4 weeks then biweekly for 4 weeks ] [ Designated as safety issue: No ]
  • Ease of use [ Time Frame: Weekly for 4 weeks then biweekly for 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EASH Device: EASH dressing
Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497210

Locations
Poland
Mikomed
Lodz, Poland
Cross Medica
Warszawa, Poland
Medservice
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.
Investigators
Principal Investigator: Keith Harding Wound Healing Research Unit, Cardiff University
  More Information

No publications provided

Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01497210     History of Changes
Other Study ID Numbers: CW-0205-11-U356
Study First Received: December 20, 2011
Last Updated: April 24, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Ethics Committee
Poland: Ministry of Health

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

ClinicalTrials.gov processed this record on June 17, 2013