Leg Ulcer
Conditions
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.
Interventions
DEVICEEASH dressing
Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.
Sponsors
ConvaTec Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | All 8 weeks | Nature and frequency of adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Improvement (peri-ulcer) | Baseline, week 4 and week 8 or final visit | — |
| Healing | Weekly for 4 weeks then biweekly for 4 weeks or final visit | Reduction in ulcer area |
| Ulcer Improvement (wound bed) | Baseline, week 4 and week 8 | — |
| Comfort | Weekly for 4 weeks then biweekly for 4 weeks | — |
| Ease of use | Weekly for 4 weeks then biweekly for 4 weeks | — |
| Ulcer pain | Weekly for 4 weeks then biweekly for 4 weeks or final visit | — |
Countries
Poland, United Kingdom
Outcome results
None listed