CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 201 enrolled
Drug / intervention
Mepilex Ag +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01036438
NCT01036438Phase 4Completed

A Double-blind, Comparative, Superiority, Multi-centre Investigation Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

Molnlycke Health Care AB·interventional·Posted Dec 21, 2009·Updated Sep 12, 2014

In Brief

A Phase 4 clinical trial evaluating Mepilex Ag and Mepilex without Ag for Venous Leg Ulcers and Mixed Leg Ulcers. Completed, enrolled 201 participants across 44 sites in 4 countries.

Detailed Summary

Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, France, Germany, Netherlands
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2009
Enrollment StartDec 1, 2009
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.5 years ago

Interventions

Mepilex Agdevice

Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.

Mepilex without Agdevice

Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.