Clinical trial to evaluate the effectiveness in the healing of chronic venous leg ulcers of rich in platelets plasma treatment.

Phase 1

• Conditions: Venous ulcers in lower limbs; MedDRA version: 19.1Level: LLTClassification code 10045373Term: Ulcers of extremitiesSystem Organ Class: 100000004858; MedDRA version: 20.0Level: LLTClassification code 10024946Term: Lower extremities ulcers ofSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-000314-29-ES
• Lead Sponsor: Servicio de Angiología y cirugía vascular. Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-31
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

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

Inclusion Criteria

1. Age> 18 years.
2. Ambulation without assistance by other people or by orthoses to perform daily activities.
3. Ulcer below the knee, with venous etiology, which does not present clinical improvement or reduction of the area after 6 weeks of cures in our center.
4. Pedal / tibial posterior pulse present or heel-arm index (ITB)> 0.8.
5. Be able to provide informed consent prior to randomization and agree to comply with all procedures included in this protocol, including the follow-up phase.
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 50

Exclusion Criteria

1. Ischemic aetiology's ulcers.
2. Ulcers of more than 6 weeks of evolution but with tendency to cicatrization (by photographic comparison with the previous week).
3. Patients of childbearing age with a positive pregnancy test on the day of screening.
4. Female patients who are breastfeeding
5. Male and female patients should agree to use highly effective contraceptive methods from the time of signing informed consent and up to at least 7 days after the completion of the study.

Study & Design

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