Status:
COMPLETED
EASH Dressing on Chronic Venous Leg Ulcers
Lead Sponsor:
ConvaTec Inc.
Conditions:
Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01497210
Start Date
November 1 2011
End Date
April 1 2012
Last Update
April 25 2012
Active Locations (6)
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1
Mikomed
Lodz, Poland
2
Cross Medica
Warsaw, Poland
3
Medservice
Zabrze, Poland
4
Wound Healing Research Unit
Heathpark, Cardiff, United Kingdom, CF14 4XN