search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


OTR4120: topical application at venous ulcers. A clinical evaluation of cicatrisation.


- candidate number3104
- NTR NumberNTR1242
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-mrt-2008
- Secondary IDs2007-244 METC
- Public TitleOTR4120: topical application at venous ulcers. A clinical evaluation of cicatrisation.
- Scientific TitleOTR4120: topical application at venous ulcers. A clinical evaluation of cicatrisation.
- ACRONYMOTR4120 application to venous ulcers
- hypothesisOTR4120 will improve healing of chronic ulcers.
- Healt Condition(s) or Problem(s) studiedVenous ulcer, Chronic ulcer
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-mrt-2008
- planned closingdate14-sep-2010
- Target number of participants100
- InterventionsFor 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 outcomeClinical 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.
- Timepointsweek: 0,5; 1; 1.5; 2; 2.5; 3; 3.5; 4; 6; 8; 10; 12; 14; 16.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. J.W. Neck, van
- CONTACT for SCIENTIFIC QUERIESDr. J.W. Neck, van
- Sponsor/Initiator Erasmus Medical Center, Department of Plastic Surgery, Department of Dermatology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Plastic Surgery, Department of Dermatology
- PublicationsN/A
- Brief summaryVenous 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)
- RECORD4-mrt-2008 - 3-feb-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl