GrUVen-I Study

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000106
• Date of registration: 03/05/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: GrUVen-I Study
• Scientific title: Human Recombinant Epidermal Growth Factor in patients with venous ulcers.
• Date of first enrolment: 04/12/2005
• Target sample size: 50
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000106-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Pedro López Saura
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB).

• Name: Pedro López Saura
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB).

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: N/A (No limit)
Gender: Both

Health Condition(s) or Problem(s) studied

Venous ulcers.

Intervention(s)

The test product was administered topically to the lesion, 3 times a week (after the treatment with physiological saline) for 8 to 12 weeks, according to the randomization of patients. Group I: viscous solution of carboxymethylcellulose (1%) which contains the human epidermal growth factor recombinant (10 ug / mL). Group II: viscous solution of carboxymethylcellulose 1% (Placebo).

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

IG/FCU/UV/0401

Source(s) of Monetary Support

Heber Biotec S.A. Ministry of Public Health.

Secondary Sponsor(s)

Not applicable