At a glance

ClinicalIndex Comparison Record

N/ACompleted· 120 enrolled

Drug / intervention

Biatain +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/NCT00627094

NCT00627094N/ACompleted

Compare CT.gov

A Randomised, Controlled and Double-blind Clinical Investigation on the Effectiveness and Safety of a Foam Dressing Biatain Ibu Non-adhesive vs. Biatain Non-adhesive, in Painful Chronic Venous Leg Ulcers

Coloplast A/S·interventional·Posted Feb 29, 2008·Updated Sep 15, 2017

In Brief

A clinical study evaluating Biatain and Biatain Ibu for Leg Ulcers. Completed, enrolled 120 participants across 13 sites in 4 countries.

Detailed Summary

The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLeg Ulcers

CountriesDenmark, France, Germany, Spain

Collaborators--

Timeline

N/ACompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedFeb 2008

Enrollment StartMar 2008

Primary CompletionApr 2009

TodayJul 2026

First PostedFeb 29, 2008

Enrollment StartMar 1, 2008

Primary CompletionApr 1, 2009

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 18.3 years ago

Interventions

Biataindevice

A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.

Biatain Ibudevice

Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.