Leg Ulcers
Conditions
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.
Interventions
DEVICEBiatain Ibu
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.
DEVICELocal best practice
N/A - since intervention is local best practice
Sponsors
Coloplast A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | Week 1, 6, 20, 33, 46 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark, Germany, Spain
Outcome results
None listed