Clinical trial NCT01497210: EASH Dressing on Chronic Venous Leg Ulcers
Official title: A Prospective, Multi-centre, Non-comparative Study to Evaluate the Safety and Preliminary Performance of the EASH Dressing on Chronic Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leg Ulcer
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Safety
timeFrame: All 8 weeks
Secondary outcomes:
measure: Ulcer Improvement (wound bed)
timeFrame: Baseline, week 4 and week 8
measure: Ulcer Improvement (peri-ulcer)
timeFrame: Baseline, week 4 and week 8 or final visit
measure: Healing
timeFrame: Weekly for 4 weeks then biweekly for 4 weeks or final visit
measure: Healing
timeFrame: 8 weeks or final visit
measure: Healing
timeFrame: 8 weeks or final visit
measure: Ulcer pain
timeFrame: Weekly for 4 weeks then biweekly for 4 weeks or final visit
measure: Comfort
timeFrame: Weekly for 4 weeks then biweekly for 4 weeks
measure: Ease of use
timeFrame: Weekly for 4 weeks then biweekly for 4 weeks
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Mikomed
city: Warszawa
country: Poland
facility: Cross Medica
city: Zabrze
country: Poland
facility: Medservice
city: Heath Park
country: United Kingdom
facility: Wound Healing Research Unit
state: Cardiff
city: Axbridge
country: United Kingdom
facility: Axbridge & Wedmore Medical Practice
state: Somerset
city: Upton
country: United Kingdom
facility: Arrowe Park Hospital
state: Wirral
Study officials:
affiliation: Wound Healing Research Unit, Cardiff University
name: Keith Harding
role: PRINCIPAL_INVESTIGATOR
References: