Improving wound healing in chronic ulcus cruris venosum with native fibrin enriched with endogenous thrombocytes (controlled prospective randomized study)

INTERVENTION: 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 volume/volume Concentration type: up to Concentration number: 65‐ Pharmaceutical form of the placebo: Impregnated pad Route of administration of the placebo: Cutaneous use CONDITION: 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 Level: LLT Classification code 10045346 Term: Ulcerated varicose veins PRIMARY OUTCOME: Main Objective: Healing process of crural venous ulcera with application of autologous platelet rich fibrin in comparison to standard treatment Primary end point(s): Reduction of wound area; Pain relief Secondary Objective: 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