Curing chronic wounds with fibri
- Conditions
- non-healing skin woundsTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-000863-34-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 33
-Chronic, non-infected wound on either the foot or leg (Texas classification grade 1 or 2, stage A or C) 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.
-BMI <40 kg/m2.
-HbA1c <10%.
-Willing to participate in our study.
-Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17
- Patient suffers from osteomyelitis, cellulitis, gangrene or any other type of infection on the investigated leg.
- Patient is known with an anaphylactic / severe systemic reaction towards human blood products.
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): healed wound or the decrease in wound area after 12 weeks of treatment, the endpoint of the trial;Timepoint(s) of evaluation of this end point: week 0, 2, 4, 6, 8, 10, 12;Main Objective: Primary Objective: increase in number of healed wounds during trial;Secondary Objective: decrease in wound volume at week 12, wound tissue perfusion; quality of life scoring; VAS pain scoring
- Secondary Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: n.a.