GrUVen-I Study
- 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
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
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.
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
- Primary Outcome Measures
Name Time Method Clinical response (taking into account the percentage of healing): Total Response: more than 90% of healing. Parcial Response: between 50% and 90% of healing. Minimal Response: between 25% and 50% of healing. Not response: less than 25% of healing. Progression: increment in size or deep, or complications. Measurement time, weekly (first 8 weeks) and at week 12.
- Secondary Outcome Measures
Name Time Method Healing time in days after injury at the end of treatment. Epithelialized area, weekly until treatment ends. Daily recovery rate of the affected area at the end of treatment. Presence of granulation tissue at the end of treatment. Quality of healing at the end of treatment and follow-up year.