NCT00628004

Brief Summary

The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 4, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

February 20, 2008

Last Update Submit

April 25, 2017

Conditions

Leg Ulcers

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Week 1, 6, 20, 33, 46

Secondary Outcomes (4)

  • Clinical occurrences

    Week 1, 6, 20, 33, 46

  • Ulcer area reduction

    Week 1, 6, 20, 33, 46

  • Ulcer status

    Week 1, 6, 20, 33, 46

  • Skin condition at healed ulcer location

    Week 1, 6, 20, 33, 46

Study Arms (3)

1

EXPERIMENTAL
Device: Biatain Ibu

2

ACTIVE COMPARATOR
Device: Local best practice

No treatment

NO INTERVENTION

No treatment as wound was healed

Interventions

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.

Also known as: Coloplast Biatain Ibu
1
Local best practiceDEVICE

N/A - since intervention is "local best practice"

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient has participated in study DK143WS
  • The patient is able to understand the treatment and is willing to comply with the treat-ment regimen.
  • The patient is willing and able to give written informed consent

You may not qualify if:

  • Pregnant or lactating women
  • Concomitant participation in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Aarhus Universitetshospital

Aarhus, 8000, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Odense Universitets Hospital

Odense, 5000, Denmark

Location

Georg-August-Universität Göttingen

Göttingen, 37075, Germany

Location

Hospital de Fuenlabrada

Fuenlabrada, 28942, Spain

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Karsten Fogh, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2008

First Posted

March 4, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2009

Study Completion

February 1, 2010

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

DK(3)DE(1)ES(1)