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: 9.1
Conditions
Interventions
Trade Name: n.a.
Product Name: Vivostat PRF
Product Code: n.a.
Pharmaceutical Form: Cutaneous spray, solution
INN or Proposed INN: autologous platelet rich fibrin
Concentration unit: % (V/V) percent v
Sponsors
Sektion Chirurgische Forschung, Univ.Klinik f.Chirurgie
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Healing process of crural venous ulcera with application of autologous platelet rich fibrin in comparison to standard treatment;Secondary Objective: ;Primary end point(s): Reduction of wound area Pain relief | — |
Countries
Austria
Outcome results
None listed