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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014