Improving wound healing in chronic ulcus cruris venosum with native fibrin enriched with endogenous thrombocytes (controlled prospective randomized study) - Improving wound healing
Phase 1
- Conditions
- The study aims to evaluate the postulated improvement in wound healing with additive application of autologous fibrin enriched with autologous thrombocytes in the treatment of chronic crural venous ulcers in comparison to standardized conventional treatment. Patients of both sexes aged 18-90 years will be selected prospectively from routine admissions with ulcers of at least 10 cm² and at most 100 cm² in size that have been present for at least 3 months and at most 3 years.MedDRA version: 9.1Level: LLTClassification code 10045346Term: Ulcerated varicose veins
- Registration Number
- EUCTR2007-005612-91-AT
- Lead Sponsor
- Sektion Chirurgische Forschung, Univ.Klinik f.Chirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Male and female patients aged 18-90 years , ulcers of at least 10cm2 and at most 100 cm2 in size, ulcers that have been present for at least 3 months and at most 3 years
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Renal failure, gravidity, insuline dependent diabetes, cachexia, dementia, hematological diseases, malignoma, positive thrombophilia screening, peripherial arterial occlusive disease, ulcera that have been present more than 3 years or less than 3 months, pretreatment with growth factors
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method