Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

Coloplast

Status: Completed

Conditions: Leg Ulcers

Treatments: Device: Local best practice; Device: Biatain Ibu

Study type: Interventional

Funder types: Industry

Identifiers

NCT00628004

DK144WS

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Pregnant or lactating women
• Concomitant participation in other studies

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

93 participants in 3 patient groups

1

Experimental group

Treatment:

Device: Biatain Ibu

2

Active Comparator group

Treatment:

Device: Local best practice

No treatment

No Intervention group

Description:

No treatment as wound was healed