Patients with venous ulcers, aged 40 to 80 years old, registered in five different health centres will be studied. MedDRA version: 14.1 Level: HLT Classification code 10040796 Term: Skin and subcutaneous tissue ulcerations System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Comarca Ezkerraldea-Enkarterri (OSAKIDETZA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients resident in Barakaldo, who are seen in treatment rooms at the Zaballa outpatient clinic or one of the following health centres: Zaballa, La Paz, Urban, or San Vicente, in the Ezkerraldea-Enkarterri Health Region of the Basque Health Service - Osakidetza. ? Men or women of 40 to 80 years of age ? Patients with stage C6 chronic venous insufficiency according to the CEAP classification ? Patients with vascular ulcers which have not responded to conventional treatment in 2 to 6 months ? Patients with normal number of platelet and red corpuscles and normal range of hematocrit. ? An ulcer of 3-5 cm in diameter ? An ABI of greater than or equal to 0.8 or less than or equal to 1.5. ? Independent patients or with sufficient family support ? Patients have given written informed consent (Appendices 03 and 04) 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: ? Chronic treatment with immunosuppressive or retroviral drugs. ? Coagulopathies. ? Patients with chronic infectious diseases. ? Patients in treatment with radiotherapy or chemotherapy. ? History of malignancy. ? Patients with more than two active ulcers. ? Pregnancy. ? Patients with current infection or febrile syndrome at the beginning of treatment. ? Patients with AAI (Ankle Arm Index) less than 0.8 and greater than 1.5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility of the treatment with autologous platelet-rich plasma (PRP), estimating the percentage of the patient who need one heal per week during the two months of treatment. To assess the potential efficacy of the treatment with autologous platelet-rich plasma (PRP), estimating the reduction of the ulcer. The area of the wound is compared between baseline, after a month and two months of treatment, measuring the area in cm2 by image processing of photographs of the ulcer using ImageJ software.;Secondary Objective: To assess the safety of autologous PRP for the treatment of venous ulcers in patients with CEAP stage 6 chronic venous insufficiency, considering reduction in pain, the percentage of infected ulcers and wound edge, in the two groups and these variables being compared between the groups. To assessed using the CIVIQ, which considers four dimensions (physical, psychological, social and pain) between baseline, after a month and two months of treatment;Primary end point(s): % OF PATIENTS WITH ONLY ONE CORE PER WEEK CIVIQ SCORE ULCER AREA;Timepoint(s) of evaluation of this end point: Basal, 5th and 9th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): AT-RISK OCCUPATION BODY WEIGHT HEIGHT BMI HISTORY OF THROMBOSIS TROPHIC LESION CAUSE OF THE LESION DISEASE COURSE PERIOD OF CONVENTIONAL TREATMENT COMPRESSION THERAPY PHLEBOTROPIC DRUGS PREVIOUS LESIONS SITE OF THE ULCER DIABETES ANKLE BRACHIAL INDEX TYPE OF DEBRIDEMENT NON-VIABLE TISSUE INFECTION PAIN WOUND EDGE LEG OEDEMA WOUND LENGTH WOUND WIDTH AMOUNT OF BLOOD TAKEN HEALING TIME NUMBER OF TREATMENT SESSIONS CHANGE PRIMARY DRESSING CHANGE SECONDARY DRESSING;Timepoint(s) of evaluation of this end point: Basal | — |
Countries
Spain
Contacts
Public ContactNatalia Burgos Alonso
Unidad de investigacion de atencion Primaria de Bizakaia
Outcome results
None listed