GrUVen-I Study

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Human Recombinant Epidermal Growth Factor in patients with venous ulcers.

Secondary indentifying numbers:

IG/FCU/UV/0401

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Heber Biotec S.A. Ministry of Public Health.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

27/04/2005

Reference number:

05-002-05-B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Mayda Quiñónez Castro MD.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Guantánamo, Agostinho Neto Hospital, Eurípides Cabrera Pérez MD. Santiago de Cuba, Saturnino Lora General Hospital, Dalia Sánchez de la Guardia MD. Havana, Enrique Cabrera General Hospital, Natalia Poll Marrón MD. Pinar del Río, Abel Santamaría Cuadrado Hospital, Juan Antonio Pérez Méndez MD. La Tunas, Ernesto Guevara de la Serna Hospital, Jose Luis Rivero Miranda MD. Sancti Spiritus, Camilo Cienfuegos Hospital, Liliam Moreno Pereira MD. Havana, Comandante Manuel Fajardo General Hospital, Máximo Sandez López MD. Holguín, Lucía Iñiguez Hospital, María Josefa Velásquez Fernández MD. La Habana, Calixto García Iñiguez General Hospital, Amelie Estevez Guas MD.

Research ethics committees:

Angiology and Vascular Surgery National Institute (centralized), June 09, 2004. Agostinho Neto Hospital, July 10, 2007. Saturnino Lora Hospital, October 16, 2007. Enrique Cabrera Hospital, November 15, 2007. Abel Santamaría Cuadrado Hospital, March 05, 2008. Ernesto Guevara de la Serna Hospital, March 21, 2008. Camilo Cienfuegos Hospital, May 21, 2008. Comandante Manuel Fajardo Hospital, June 23, 2008. Lucía Iñiguez Hospital, June 27, 2008. Calixto García Iñiguez Hospital, July 16, 2008.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

04/12/2005

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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).

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

N/A (No limit)

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Pedro

Middle Name:

Antonio

Last Name:

López Saura

Affiliation:

Center for Genetic Engineering and Biothecnology (CIGB).

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

lopez.saura@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Pedro

Middle Name:

Antonio

Last Name:

López Saura

Affiliation:

Center for Genetic Engineering and Biothecnology (CIGB).

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

lopez.saura@cigb.edu.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000106

Date of Registration in Primary Registry:

2011-05-03

Record Verification Date:

2011-04-21 20:00

Link to the spanish version:

Click here [3]