GrUVen-I Study

Phase 2

Completed

• Conditions: Venous ulcers.

• Registration Number: RPCEC00000106
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-03
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Informed consent of patient. 2.Age major than 18 years old. 3.Diagnosis of an only venous ulcer in lower limbs, not infected, up to 1 cm2 and minor than 10 cm2.

Exclusion Criteria

1.Diabetes mellitus, Sickle Cell anemia. 2.Cancer (except the basal cell carcinoma and the cervix cancer in situ after surgery and complete cured). 3.Metabolic disease (liver disease, renal disease, pancreatic diseases, colagenosis) Mild o serious anemia (Hb = 11 g/L for women y 12 g/L for men). 4.Severely disabled (caquexia, critical patients, life-threatening diseases). 5.Uncontrolled Hypertension due to clinical examination. 6.Peripheral arterial chronic diseases referred by patient and confirm bay clinical examination. 7.Patients treated with steroids in the last 3 months. 8.Patients treated with EGF in the last 30 days. 9.Serious psychiatric disorder and other disease that limit informed consent. 10.Pregnancy or nursery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified