EASH dressing
DeviceApply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.
NCT Number: NCT01497210
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Mikomed, Lodz, Poland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.
Time frame: All 8 weeks
Nature and frequency of adverse events.
Time frame: Baseline, week 4 and week 8
Time frame: Baseline, week 4 and week 8 or final visit
Time frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit
Reduction in ulcer area
Time frame: 8 weeks or final visit
Number of subjects healed
Time frame: 8 weeks or final visit
Time to healing
Time frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit
Time frame: Weekly for 4 weeks then biweekly for 4 weeks
Time frame: Weekly for 4 weeks then biweekly for 4 weeks
ConvaTec Inc.
Industry
A Prospective, Multi-centre, Non-comparative Study to Evaluate the Safety and Preliminary Performance of the EASH Dressing on Chronic Venous Leg Ulcers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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