Improving wound healing in chronic ulcus cruris venosum with native fibrin enriched with endogenous platelets and vagal stimulation with p-Stim (a pilot study) - Improving wound healing
- Conditions
- 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: 12.0Level: LLTClassification code 10045346Term: Ulcerated varicose veins
- Registration Number
- EUCTR2009-017050-12-AT
- Lead Sponsor
- Sektion Chirurgische Forschung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>pain relief
- Secondary Outcome Measures
Name Time Method