CITOPROT-III

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:

Intralesional administration of recombinant Epidermal Growth Factor in patients with diabetic foot and risk of major amputation.

Secondary indentifying numbers:

IG/FCEI/PD/0503

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biothecnology

Source(s) of monetary or material support:

Heber Biotec S.A., Ministry of Public Health (MINSAP).

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 :

20/04/2006

Reference number:

833/05-002-06-B.

Principal investigator

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

First name:

Jose

Last name:

Fernandez Montequin

Medical Specialty :

II Degree Specialist in Angiology and Vascular Surgery

Affiliation:

National Institute of Angiology and Vascular Surgery

Postal address:

Calzada del Cerro No. 1551 esquina a Domínguez

City:

Havana

País:

Cuba

Zip Code:

12000

Telephone:

+53-78776341

Email address:

email@not.entered

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:

Havana, “Enrique Cabrera” General Hospital, Dr. Heriberto Artaza-Sanz.

Havana, “Joaquín Albarrán” General Hospital, Dr. Lourdes Morejón-Vega.

Havana, “Manuel Fajardo” General Hospital, Dr. Máximo Sández.

Havana, “Calixto García” General Hospital, Dr. Julio Nuñez.

Havana, Institute of Military Medicine “Luis Díaz Soto”, Dr. José E. Sauri-Chávez.

Havana, “Miguel Enriquez” General Hospital, Dr. Justa Peñalver.

Pinar del Río, “Abel Santamaría” Hospital, Dr. Laureano Peña-Bazart.

Matanzas, “J.R.López Tabranes” Hospital, Dr. Arístides García-Herrera.

Villa Clara, “Arnaldo Milián Castro” Hospital, Dr. Cecilio González-Benavides.

Cienfuegos, “Gustavo Aldereguía Lima” Hospital, Dr. José Ferrá.

Sancti Spíritus, “Camilo Cienfuegos” Hospital, Dr. Pablo Sánchez-Penton.

Ciego de Ávila, “Antonio Luaces Iraola” Hospital, Dr. Carlos Hernández Cannete.

Camaguey, "Manuel Ascunce Domenech" Hospital, Dr. Fidel Rivero-Fernández.

Las Tunas, "Ernesto Guevara" Hospital, Dr. José Luis Solis-Licea.

Holguín, “Lucía Iñiguez” Hospital, Dr. Armando González-Expósito.

Granma, “Carlos Manuel de Céspedes” Hospital, Dr. Alberto Vázquez-Proenza.

Santiago de Cuba, “Saturnino Lora” Hospital, Dr. Natacha Sancho-Soutelo.

Santiago de Cuba, “Joaquín Castillo Duany” Hospital, Dr. Celso Suárez-Lescay.

Guantánamo, “Agostino Neto” Hospital, Dr. Georgina Greaves-Turro.

Research ethics committees:

“Ad hoc” Ethics Committee, approved on November 30, 2005.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

27/09/2006

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:

Diabetic foot ulcer.

Health condition(s) code:

Diabetic Foot

Foot Ulcer

Leg Ulcer

Skin Ulcer

Diabetic Angiopathies

Vascular Diseases

Diabetes Complications

Diabetic Neuropathies

Diabetes Mellitus

Endocrine System Diseases

Cardiovascular Diseases

Intervention(s):

Treatment groups are: Group I: EGF 75 µg Group II: EGF 25 µg Group III; Placebo Each vial to be dissolved with 5 mL water for injection; administered as intralesional infiltrations 3 times per week up to 8 weeks. Treatment should be discontinued if useful granulation tissue covers the whole lesion extension or its area is less than 1 cm2. Infiltrations should be done after lesion cure, on the ulcer borders, with 26 mm needles and on the ulcer bottom, in case of deep lesions, with 24 mm needles. Cleaner zones of the ulcers should be infiltrated first and needles to be changed for each puncture site in order to prevent infection transmission. Afterwards, the lesion should be covered with a saline-moistened clean gauze.

Intervention code:

Epidermal Growth Factor

Injections, Intralesional

Placebos

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):

Primary outcome variable: Proportion of patients with >50% granulation response after 2 weeks of treatment. Useful productive material is that able to lead to complete lesion closure by second intention or to sustain and feed an autograft. It is characterized macroscopically by the presence of granular, reddish, diffuse, disperse, shining, and easily bleeding formations. Response is classified according to the percent of the lesion area covered by granulation tissue: 1.No response: 0 – 25% 2.Minimal response: 26 – 50% 3.Partial response: 51 – 75% 4.Complete response: > 75 % Partial or complete response at 2 weeks of treatment are considered therapeutic success. No response or minimal response are considered failures.

Key secondary outcomes:

1.Proportion of patients that achieve complete granulation response at the end of treatment. 2.Time to complete granulation response. 3.Proportion of patients that reaches complete healing up to one year follow-up, defined as wound epithelization and complete closure, without secretion or need of bandage. 4.Need for major amputation. 5.Recurrence, defined as the appearance of a new ulcer on the same limb, both at the same previously affected site or at a new site.

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:

None

Inclusion criteria:

1.Diagnosis of diabetic foot ulcer, Wagner's grade 3 or 4. 2.Age = 18 years. 3.Patient’s signed informed consent.

Exclusion criteria:

1.Ulcer area < 1 cm2. 2.Haemoglobin <100 g/l. 3.Uncompensated chronic diseases (ischemic heart illness, diabetic coma or ketoacidosis, renal failure). 4.History or suspect of malignancies (physical examination, rectal tact, breast examination, abdominal ultrasound, thorax radiography and blood chemistry). 5.Use of drugs that can impair evaluation: immunosuppressors or corticosteroids. 6.Psychiatric or neurological diseases that could impair proper reasoning for consent. 7.Pregnancy or nursing.

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:

147

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

Specialty:

Doctor of Biological Sciences

Affiliation:

Center for Biological Research.

Postal Address:

Calle 134 entre 23 y 25, Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

+53-7-2087379

Email :

lopez.saura@cigb.edu.cu

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

Specialty:

Doctor of Biological Sciences

Affiliation:

Center for Biological Research.

Postal Address:

Calle 134 entre 23 y 25, Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

+53-7-2087379

Email :

lopez.saura@cigb.edu.cu

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:

RPCEC00000060

Date of Registration in Primary Registry:

2009-02-26

Record Verification Date:

2009-02-21 19:00

Link to the spanish version:

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Proceso de Registro

CITOPROT-III

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