Curing chronic wounds with fibrin.

Phase 2

Recruiting

• Conditions: Chronische wonden; Chronic wounds; ulcers; 10012653; 10014982

• Registration Number: NL-OMON50490
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

- Chronic, non-infected wound on either the foot or leg (Texas classification 1
or 2) that is non-respondent to treatment for at least 6 weeks.
- The size of the wounds must be between 1-20 cm2.
- Older than 18 years.

Exclusion Criteria

- Patient suffers from osteomyelitis, cellulitis, gangrene or any other type of
infection on the investigated leg.
- Patient is known with alcohol or drug abuse.
- It is impossible to correctly inform the patient (language barrier, mental
problems).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the effect of the treatment: the number of completely healed<br /><br>wounds during the trial period of 12 weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Measurement of the wound area and depth (fortnightly) by the researcher as long<br /><br>as the wound is open (max 12 weeks).<br /><br>Improved perfusion in the wounded area.<br /><br>Score Quality of Life by questionnaires (EQ5D and Cardiff Wound Impact<br /><br>Questionnaire); VAS pain score).</p><br>