|- candidate number||3104|
|- NTR Number||NTR1242|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-mrt-2008|
|- Secondary IDs||2007-244 METC|
|- Public Title||OTR4120: topical application at venous ulcers. A clinical evaluation of cicatrisation.|
|- Scientific Title||OTR4120: topical application at venous ulcers. A clinical evaluation of cicatrisation.|
|- ACRONYM||OTR4120 application to venous ulcers|
|- hypothesis||OTR4120 will improve healing of chronic ulcers.|
|- Healt Condition(s) or Problem(s) studied||Venous ulcer, Chronic ulcer|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-mrt-2008|
|- planned closingdate||14-sep-2010|
|- Target number of participants||100|
|- 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 of a
sterile solution of physiological salt.
|- Primary outcome||Clinical improvement of the investigated ulcers, measured as the reduction of the wound area in time.|
|- Secondary outcome||- 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.
|- Timepoints||week: 0,5; 1; 1.5; 2; 2.5; 3; 3.5; 4; 6; 8; 10; 12; 14; 16.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.W. Neck, van |
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.W. Neck, van |
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Plastic Surgery, Department of Dermatology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Plastic Surgery, Department of Dermatology|
|- Brief summary||Venous ulcers are, in aging Western societies, an increasing problem and
display a significant impact on the quality of life of patients and on
health economics. |
This study aims to investigate, in a double blinded, randomized
controlled trial, the effectiveness of treatment of chronic wounds
(venous ulcers) with a new product, in which a regenerating agent, made
of sugar, reactivates at very low doses our natural regeneration
potential. In total, 70 patients with venous ulcers (>6 months open with
no or insufficient signs of healing) will be included. The ulcer(s) will
be cleaned and the product will be applied for only 5 minutes and
removed. This is enough to this sugar to stabilize the wound and to
allow the tissue to repair. This treatment will be followed by standard
care. The study is for a duration of 16 weeks for each patient. From
preliminary studies a dramatic reduction of ulcer size, time to complete
healing and pain are expected without any side effect.
|- Main changes (audit trail)|
|- RECORD||4-mrt-2008 - 3-feb-2009|