EASH Dressing on Chronic Venous Leg Ulcers

A Prospective, Multi-centre, Non-comparative Study to Evaluate the Safety and Preliminary Performance of the 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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcer
• Intervention / Treatment: Device: EASH dressing

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland
    • Mikomed
  • Warszawa, Poland
    • Cross Medica
  • Zabrze, Poland
    • Medservice
• United Kingdom
  • Cardiff
    • Heath Park, Cardiff, United Kingdom, CF14 4XN
      • Wound Healing Research Unit
  • Somerset
    • Axbridge, Somerset, United Kingdom, BS26 2BJ
      • Axbridge & Wedmore Medical Practice
  • Wirral
    • Upton, Wirral, United Kingdom, CH49 5PE
      • Arrowe Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Nature and frequency of adverse events.	All 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ulcer Improvement (wound bed)		Baseline, week 4 and week 8
Ulcer Improvement (peri-ulcer)		Baseline, week 4 and week 8 or final visit
Healing	Reduction in ulcer area	Weekly for 4 weeks then biweekly for 4 weeks or final visit
Healing	Number of subjects healed	8 weeks or final visit
Healing	Time to healing	8 weeks or final visit
Ulcer pain		Weekly for 4 weeks then biweekly for 4 weeks or final visit
Comfort		Weekly for 4 weeks then biweekly for 4 weeks
Ease of use		Weekly for 4 weeks then biweekly for 4 weeks

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Principal Investigator: Keith Harding, Wound Healing Research Unit, Cardiff University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: December 20, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (Estimate): December 22, 2011

Study Record Updates

• Last Update Posted (Estimate): April 25, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: CW-0205-11-U356