EASH Dressing on Chronic Venous Leg Ulcers

Phase 2

Completed

• Conditions: Leg Ulcer
• Interventions: Device: EASH dressing

• Registration Number: NCT01497210
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EASH	EASH dressing	-

Primary Outcome Measures

Name	Time	Method
Safety	All 8 weeks	Nature and frequency of adverse events.

Secondary Outcome Measures

Name	Time	Method
Ease of use	Weekly for 4 weeks then biweekly for 4 weeks
Ulcer Improvement (wound bed)	Baseline, week 4 and week 8
Ulcer Improvement (peri-ulcer)	Baseline, week 4 and week 8 or final visit
Healing	8 weeks or final visit	Time to healing
Ulcer pain	Weekly for 4 weeks then biweekly for 4 weeks or final visit
Comfort	Weekly for 4 weeks then biweekly for 4 weeks

Trial Locations

Locations (6)

Mikomed; 🇵🇱 Lodz, Poland

Medservice; 🇵🇱 Zabrze, Poland

Cross Medica; 🇵🇱 Warszawa, Poland

Arrowe Park Hospital; 🇬🇧 Upton, Wirral, United Kingdom

Wound Healing Research Unit; 🇬🇧 Heath Park, Cardiff, United Kingdom

Axbridge & Wedmore Medical Practice; 🇬🇧 Axbridge, Somerset, United Kingdom