EASH Dressing on Chronic Venous Leg Ulcers

Convatec

Status and phase

Completed

Phase 2

Conditions

Leg Ulcer

Treatments

Device: EASH dressing

Study type

Interventional

Funder types

Industry

Identifiers

NCT01497210

CW-0205-11-U356

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.