Pharmacokinetics of intralesional EGF in patients with 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 in intralesional administration of recombinant Epidermal Growth Factor in patients with diabetic foot ulcers.

Secondary indentifying numbers:

IG/FCEI/PD/0707

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). Praxis Pharmaceutical.

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 :

15/10/2007

Reference number:

05-021-07-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 :

Specialist II Degree in Angiology and Vascular Surgery

Affiliation:

National Center for Toxicology (CENATOX)

Postal address:

Avenida 31 y 114, Marianao

City:

Havana

País:

Cuba

Zip Code:

11400

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:

National Center of Toxicology (CENATOX), august 21, 2007

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

19/11/2007

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, Wagner grades 1 or 2

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):

Group I. EGF-25 µg, administered intralesionally 3 times a week until lesion size is reduced to 1 cm2 or for up to 12 weeks. Group II. EGF-75 µg, administered intralesionally 3 times a week until lesion size is reduced to 1 cm2 or for up to 12 weeks. Group III. Placebo, administered intralesionally 3 times a week until lesion size is reduced to 1 cm2 or for up to 12 weeks. EGF bulb reconstitution and dilution will be performed using 5 mL of injection water.

Intervention code:

Epidermal Growth Factor

Injections, Intralesional

Placebos

Intervention keyword:

RhEGF

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):

Basal EGF plasma concentration; 5, 15, 30, 45 and 60 minutes after first and last applications, and 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after first and last applications.

Key secondary outcomes:

Ratio of patients with total occlusion 12 weeks after commencing treatment.

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:

70 years

Inclusion criteria:

1. Patients with DM type 1 or 2 under ADA criteria. 2. Patients of both sexes, aged >= 18 and <= 70. 3. Diabetic foot ulcers classified by Wagner as grade 1 (covering an area >10 and =50 cm2) or grade 2 (covering and area >1 and =50 cm2). 4. Neuropathic ulcer evidenced by palpable distal pulses and ankle/arm index (AA/I) = 0.8 and < 1.3. If arterial calcification occurs (AA/I = 1.3), the finger/arm index (FA/I) will be used. It should be over 0.7. 5. Ulcer = 4 week evolution. 6. Reproductive age men and women should use effective contraceptive methods up to three months after completing treatment. 7. Patients giving informed consent.

Exclusion criteria:

1. Infection signs or symptoms. 2. Osteomyelitis or ulcers with bone exposure. 3. Poorly controlled diabetes mellitus (Hb A1c > 10%). 4. Morbid obesity (body mass index > 40). 5. Connective tissue disease. 6. Use of drugs likely to interfere with (corticoids or inmunosuppressors) or to favor cicatrisation (pentoxifylline, prostaglandin, and other growth factors). 7. Uncontrolled systemic or serious diseases: cardiopathies (especially ischemic cardiopathy or heart failure with edema), moderate or serious liver failure, kidney failure with serum creatinine values >200mmol/l. 8. Clinical malnutrition signs or albumin levels < 35 g/L. Hemoglobin < 100g/L. 9. Hypersensitivity to the product or any of its components. 10. History of current or past neoplasia. 11. Failure to conduct relevant evaluations or keep appropriate drainage in affected limb. 12. Previous EGF treatment. 13. Psychiatric or neurological diseases preventing informed consent. 14. History of alcoholism or drug addiction one year prior to inclusion. 15. Pregnancy or breastfeeding.

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

Specialty:

Doctor of Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave 31 / 158 y 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

Specialty:

Doctor of Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology. (CIGB)

Postal Address:

Ave 31 / 158 y 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:

RPCEC00000047

Date of Registration in Primary Registry:

2010-12-24

Record Verification Date:

2011-05-23 20:00

Link to the spanish version:

Click here [3]