The study aims to evaluate the improvement in wound healing in chronic crural venous ulcers by comparing additive application of autologous fibrin enriched with autologous thrombocyted to standardized treatment in patients aged 18-80 years with ulcers from 10 cm2 to 100 cm2 in size that have been present for 3-36 months. We also examine the wound healing improvement with auricular electro-stimulation and the effect of the simultaneous use of PRF and electro-stimulation. MedDRA version: 12.0 Le
Conditions
Interventions
Product Name: PRF (platelet rich fibrin) prepared by Vivostat Processor Unit
Product Code: n.a.
Pharmaceutical Form: Cutaneous spray, suspension
INN or Proposed INN: autologous platelet rich fibrin
CA
Sponsors
Sektion Chirurgische Forschung
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male and female patients aged 18-80 years, ulcers of at least 10cm2 and at most 100cm2 in size, ulcers that have been presented 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, lactation period, insuline dependent diabetes, cachexia, dementia, hematological diseases, malignoma, positive thrombophilia screening, peripheral arterial occlusive disease, ulcera that have been present more than 3 years and less than 3 months, pretreatment with growth factors, treatment with drugs that provide wound healing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: healing process of crural venous ulcera with application of autologous platelet rich fibrin with or without electrostimulation in comparison to standardized treatment ;Secondary Objective: pain reduction;Primary end point(s): reduction of wound area pain relief | — |
Countries
Austria
Outcome results
None listed