Randomised Clinical Study of Safety of Efficacy of Extracelular Matrix (SIS- Biodesign layer) in combination with growth factors released fromAutologous Platelet Rich Plasma Concentrate separated in the same time procedure with SmartPReP2 separator for Wound Healing.Ischemic and venous leg Ulcers will be treated with Biodesign+autologous PRP concentrate in randomised study.
- Conditions
- Chronical ischemic and venous ulcersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-003104-39-CZ
- Lead Sponsor
- Fakultní nemocnice Ostrava,Czech republic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
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
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 < 0,5 for CLI
- albuminu < 2,5 g/dl or prealbuminu < 5,0 g/dL
- Hgb A1c > 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Secondary endpoints:<br>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.<br>2. Patients count in each group with 90% wound closure at the end of 12 weeks FU<br>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