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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.
Mikomed
Lodz, Poland
Cross Medica
Warsaw, Poland
Medservice
Zabrze, Poland
Wound Healing Research Unit
Heathpark, Cardiff, United Kingdom
Safety
Nature and frequency of adverse events.
Time frame: All 8 weeks
Ulcer Improvement (wound bed)
Time frame: Baseline, week 4 and week 8
Ulcer Improvement (peri-ulcer)
Time frame: Baseline, week 4 and week 8 or final visit
Healing
Reduction in ulcer area
Time frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit
Healing
Number of subjects healed
Time frame: 8 weeks or final visit
Healing
Time to healing
Time frame: 8 weeks or final visit
Ulcer pain
Time frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit
Comfort
Time frame: Weekly for 4 weeks then biweekly for 4 weeks
Ease of use
Time frame: Weekly for 4 weeks then biweekly for 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Axbridge & Wedmore Medical Practice
Axbridge, Somerset, United Kingdom
Arrowe Park Hospital
Upton, Wirral, United Kingdom