Protocol for the clinical evaluation of wounds after topical administration of OTR4120 to ulcers.

Protocol for the clinical evaluation of wounds after topical administration of OTR4120 to ulcers. - OTR4120 application to ulcers.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35339

Enrollment

124

Registered

2007-12-21

Start date

2008-03-12

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic ulcers venous ulcers

Interventions

Compress, soaked in OTR4120 or placebo, will be placed uopn the ulcer for a period of 5 min.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1- Minors 2- Pregnant or breastfeeding women 3- Patients unable to sign the informed consent 4- Uninsured patients 5- Osteomyelitis patients

Design outcomes

Primary

Measure	Time frame
Clinical improvement of the ulcer, measured as reduction in wound size in time.	—

Secondary

Measure	Time frame
1- Complete healing of the ulcer, measured as the time needed for complete healing. 2- Pain reduction without the use of pain medication.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)