EASH Dressing on Chronic Venous Leg Ulcers

Study Overview
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Brief Summary
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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.

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

Conditions
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Leg Ulcer

Intervention / Treatment
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* Device: EASH dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EASH<br> | Device: EASH dressing<br>* Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.<br>|

What is the study measuring?
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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 |