Pharmacokinetics of the Intralesional administration of rhEGF (doses: 75 µg and 225 µg) in advance Diabetic Foot Ulcers

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:

Pharmacokinetics of the Intralesional administration with two doses of rhEGF (75 µg and 225 µg) in patients with advance Diabetic Foot Ulcers

Secondary indentifying numbers:

IG/FCEI/PD/1114

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB)

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 :

06/12/2011

Reference number:

05.016.11.B

Principal investigator

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

First name:

- CENATOX. Carlos Alberto González, MD, 2nd grade Pharmacologist. - CIMEQ. Yolanda Cruz Gómez, BSc, Biochemists, Head of the Clinical Laboratory.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

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:

Not applicable

Research ethics committees:

- CENATOX. November 10, 2011. - CIMEQ. November 15, 2011.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

27/07/2012

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:

Deep Ischemic Diabetic Foot Ulcers that reach joint capsule and bone, with or not bone exposition, without osteomyelitis and infection.

Intervention(s):

All the patients will receive the same treatment. The application will start with 75 µg three time per week during the first week, follow up to 225 µg once per week up to 8 week or less if patients closure of lesion before.

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):

EGF plasmatic levels (ELISA tecnhique). Measuring times: at the screening, 0 h (before first injection) and 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 12 h and 24 h after each application of 75 or 225 µg. Severe adverse events (Appearance of severe adverse events (Yes, No). Measuring time: at each administration during the 8 weeks of treatment.

Key secondary outcomes:

Complete closure of the lesion (defined by the epithelization and total closure of the lesion without secretion or dressing application). Measuring time: before treatment, and weeks 4, 8, 12, 16 and 20. One-hundred percent of soft granulation tissue. Measuring time: before treatment, and weeks 4, 8, 12, 16 and 20. Clinical adverse events (AE). Measuring time: at each administration during 8 weeks of treatment -Appearance of AE (Yes, No) -Type of AE (name of the AE) -Duration (time between beginning and end of the event), -Intensity of AE (mild, moderate, severe) -Relation of causality (remote, possible, probable, very probable) -Result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation). Anti-EGF antibodies (by ELISA technique. Patients that develop antibodies (Yes, No)). Measuring time: before treatment, week 8 and week 20.

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. Written, informed consent to participate, previous to any procedure described in the protocol. 2. Age = 18 years. 3. Size of the ulcer = 10 cm2 and = 30 cm2. 4. Deep and ischemic ulcers, to reach subcutaneous cellular tissue up to tendon or joint capsule, bone, with or not bone exposition, without osteomyelitis and infection. 5. Pressure index Ankle/Brachial = 0,6 < 0,9. 6. Ulcers = 4 weeks of evolution (treated or not). 7. Women into fertile age should use an effective contraceptive method until three months after the treatment has concluded.

Exclusion criteria:

1. Hemoglobin <100 g/L. 2. Connective tissue diseases. 3. Morbid obesity (body mass index > 40). 4. Use of drugs that could interfere (corticosteroids or immunosuppressants) or favor the healing (prostaglandin and others growth factors). 5. Systemic decompensated or severe diseases (Ischemic heart disease or diabetic coma), moderaty or severe liver failure (ALT, AST or GGT twices over the normal value and prothrombin values 3 sec. over the control), or renal failure with creatinine values > 200 µmol/L. 6. Signs of clinical malnutrition or albumin levels < 30 g/L. 7. Hypersensibility to any of to the components of the product. 8. Antecedents or suspicion of malignant diseases by general physical examination, thorax radiography, abdominal and pelvic ultrasound, ginecological examination, rectal tact, PSA. 9. Impossibility to complete with the foresee evaluations and visits. 10. Treatment with any EGF formulation within the 3 previous months. 11. Psychiatric or neurological diseases that impede the patient to give their consent. 12. Alcoholism story in the last two months (consumption not less than 1/4 bottle of rum or 1 bottle of wine or 3 beers, at a frequency not less than 3 times a week) or addiction to drugs in the previous year. 13. 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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

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:

Verena Amaurys Pedro Julio

Last Name:

Muzio-González, PhD del Río-Martín, MD López-Saura, PhD Baldomero-Hernández, MD

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave 31 / 158 and 190, Cubanacán, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-208-7379; 2087465 ext. 108

Email :

verena.muzio@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:

Verena Amaurys Pedro Julio

Last Name:

Muzio-González, PhD del Río-Martín, MD López-Saura, PhD Baldomero-Hernández, MD

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave 31 / 158 and 190. Cubanacán Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-208-7379; 2087465 ext. 108

Email :

verena.muzio@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:

RPCEC00000148

Date of Registration in Primary Registry:

2013-02-08

Record Verification Date:

2013-02-04 19:00

Link to the spanish version:

Click here [3]