To validate that OTR4120 will improve the healing of chronic ulcers.
ID
Source
Brief title
Condition
- Diabetic complications
- Skin vascular abnormalities
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical improvement of the ulcer, measured as reduction in wound size in
time.
Secondary outcome
1- Complete healing of the ulcer, measured as the time needed for complete
healing.
2- Pain reduction without the use of pain medication.
Background summary
Chronc ulcers display an increasing incidence due to our aging society and put
a strong burden on the patients' quality of life.
Matrix and cellular characteristics are changed in skin ulcers ranging from
dermis to muscle layer. Destruction of cells and matrix releases enzymes that
attack the glycosaminoglycans (GAGs) and proteins in the extracellulair matrix.
The natural proces of tissue repair requires matrix reconstitution and cellular
replacement. If these processes are hampered, ulcers may become chronic.
OTR4120 is a structural and functional analogue of GAG. When applied to an
ulcered area, it will bind to tissue parts where the natural GAGs are degraded.
This way OTR4120 will act as a wound healing enhancer by protecting
matrix-associated proteins from degradation and by enhancing cell migration
into the wound area.
Study objective
To validate that OTR4120 will improve the healing of chronic ulcers.
Study design
Dubbel blinded, randomized, placebo controlled trial in 2 groups of 62 patients
having chronic ulcers. Group 1 will be treated during 4 months using OTR4120.
Group 2 will be placebo treated. In addition, both groups will receive their
standardized regular treatment.
Intervention
Compress, soaked in OTR4120 or placebo, will be placed uopn the ulcer for a
period of 5 min.
Study burden and risks
Burden: OTR4120 or placebo on a wetted gauze, will be placed on the wound
during 5 minutes followed by the standardized regular treatment.
Risks: no risks in the use of the dextranderivative OTR4120, used in the
microgram range per treatment, are known or expected.
Dr Molewaterplein 50
3015 GD Rotterdam
Nederland
Dr Molewaterplein 50
3015 GD Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. Informed consent.
2. Aged over 18 yrs.
3. Patients displaying an ulcus cruris following PUSH tool criteria or diabetic foot ulcer.
4. Women in reproductive age take contraceptive medication.
Exclusion criteria
1- Minors
2- Pregnant or breastfeeding women
3- Patients unable to sign the informed consent
4- Uninsured patients
5- Osteomyelitis patients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20585.078.07 |
| Other | NTR1242 NTR1603 |