ulcer venous chronic
Conditions
Interventions
For the OTR4120-group, the medical device Cacipliq20
consists of a sterile solution of OTR4120 (100microgram/ml) in
physiological salt.
For the placebo group the medical device Cacipliq20 consists
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent. 2. Age at least 18 years. 3. Women at a reproductive age should use birth control during the entire study period 4. Patients must have a venous ulcus cruris present for at least 6 months and scored according the PUSH tool (score at least 4).
Exclusion criteria
Exclusion criteria: 1. Minor aged patients. 2. Pregnant or breast-feeding women. 3. Inclusion in another clinical trial in the 4 weeks preceeding this study and/or during this study. 4. Patients who, because of personal circumstances are unable to comply to the study visit scheme. 5. Patients who, because of mental limitations, are unable to visualise the degree of pain and itch of the ulcer. 6. Patients unable to sign the informed consent. 7. Uninsured patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement of the investigated ulcers, measured as the reduction of the wound area in time. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Complete healing of the ulcer (measured as the time to complete healing). - Improvement of the pain status without the use of analgetica. - Reduction of the total score in the PUSH tool. - Safety of the experimental treatment. | — |
Contacts
Public ContactJ.W. Neck, van
Dept of Plastic Surgery, Ee15.91 's Gravendijkwal 230
Outcome results
None listed