Check if fatible and can be effective if the use of PRP in vascular ulcers in the field of primary care

• Conditions: Patients with venous ulcers, aged 40 to 80 years old, registered in five different health centres will be studied.; MedDRA version: 14.1Level: HLTClassification code 10040796Term: Skin and subcutaneous tissue ulcerationsSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-002247-20-ES
• Lead Sponsor: Comarca Ezkerraldea-Enkarterri (OSAKIDETZA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-19
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

?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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified