|- candidate number||5239|
|- NTR Number||NTR1603|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jan-2009|
|- Secondary IDs||NTR1242 |
|- Public Title||OTR4120: topical application at diabetic ulcers. A clinical evaluation of cicatrisation.|
|- Scientific Title||OTR4120: topical application at diabetic ulcers. A clinical evaluation of cicatrisation.|
|- ACRONYM||OTR4120 application to chronic ulcers|
|- hypothesis||OTR4120 will improve healing of chronic ulcers.|
|- Healt Condition(s) or Problem(s) studied||Chronic ulcer, diabetic 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 or a diabetic ulcer present for at least 4 months.
|- 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.
8. Patients having osteomyelitis.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2009|
|- 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||1. Complete healing of the ulcer (measured as the time to complete healing). |
2. Improvement of the pain status without the use of analgetica.
3. Reduction of the total score in the PUSH tool.
|- 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|
|- status||open: patient inclusion|
|- 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||Diabetic 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 with a new product, in which a regenerating agent, made of sugar, reactivates at very low doses our natural regeneration potential. In total, 100 patients with ulcers (>4 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||30-jan-2009 - 3-feb-2009|