Chronical ischemic and venous ulcers
Conditions
Interventions
Trade Name: Autologous Platelet Rich Plasma
Product Name: Autologous Platelet Rich Plasma
Product Code: aPRP
Pharmaceutical Form: Concentrate for cutaneous spray, emulsion
Sponsors
Fakultní nemocnice Ostrava,Czech republic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient meets one or more diagnostic criterias: - Diabetes mellitus Typ I or Type II - Chronic Venous Insufficiency Patients with chronic wounds meets all of this criterias: - Time of chronic wound occurrence is between 12 an 52 weeks - Wound is crossing dermis into subcutaneous tissue - Area diameter is less then 40cm2 in the largest area measurred by Adobe Photoshop software 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: General exclusion criterias: - Age under 18 Y at the time of the treatment - Pregnant patients or women planning the pregnancy in the period of study run. - Patients enrolled in the other study - Patients wo didn't signed informed consent or are anaible for the the FU controls Eclusion criterias under clinical status: - patients with haemostatic problems after the first necrotic tissue debridment - the diameter of the wound had diminished in more then 30% after screening period before study enrollement time. - wound is penetrating the bone area - Wound dressing change is necessary more the 2 times per week - Ancle brachial index -ABI 12% of level - Wound infection - Osteomyelitis - Celulitis - Legg gangrene - Necrotis or avascular ischemic wound basement layer - Swelling > scale 2+ - Hyperbaroxic therapy in the last 7 days - Local antibiotics, antiseptic or enzymatic therapy in the last 7 days - Aplication of the KGF,TGF or other growth factors localy in the last 30 days - Bone or tendon procedures in the last 30 days - revascularisation procedure in the last 60 days on the target legg - Malignancy in the place of the wound - Radiation therapy of the wound are around 6 cm - Organ transplantation in the patients history - Haemocoagulation disease - Vasculitis - Lymphedema - AIDS - Cirrhosis - Charcott legg deformity - Hairy cell anemia - Alergy on local anesthetics - Alergy on pig products - Haemodialysis - Chemotherapy - Local steroid therapy (>10 mg of prednison/day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary end-point of the study is determining in efficacy of the combination treatment by aPRP+(ECM-Biodesign layer) is better than (ECM) aplied only and against the control study group.;Secondary Objective: Secondary endpoint is to collect all informations of chronic wound treatment efficacy by combination of aPRP+ECM aplication, which will be the basement for the multicentr clinical trial focused on the efficay of this chronic wound teratment strategy. ;Primary end point(s): Primary end-point of the clinical study is the number of EA ( infection in the wound, chronic inflamatory proccess, alergy reaction,redness, pain, swelling or blisters or induration onset) in each clinical study group during 12 weeks of the clinical study follow-ups.;Timepoint(s) of evaluation of this end point: 12 weeks of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: 1. Patients count in each group with total woubd occlusion in 12 weeks of clinical study follow-up. Complete occlusion is defined as complete re-epithelialisation of the target wound without any necessity of dressing cover. 2. Patients count in each group with 90% wound closure at the end of 12 weeks FU 3. Time to complete closure in each patient in the 12 weeks of the study FU.;Timepoint(s) of evaluation of this end point: 12 weeks of follow-up | — |
Countries
Czech Republic
Contacts
Public ContactEthical comittee
Fakultní nemocnice Ostrava
Outcome results
None listed