Clinical trial, phase II, to evaluate rhEGF efficacy and safety at a dose of 25 or 75 micrograms intralesionally in patients with diabetic foot ulcer (Wagner grade 1 or 2).

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:

Phase II, multi-centered, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety of recombinant human Epidermal Growth Factor (rhEGF) at a dose of 25 or 75 micrograms intralesionally 3 times a week for up to 12 weeks, in patients with diabetic foot ulcer (Wagner grade 1 or 2).

Secondary indentifying numbers:

IG/FCEI/PD/0708

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB), Havana.

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 :

02/01/2008

Reference number:

24-089-10-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

Country:

Cuba

Zip Code:

11400

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, CIMEQ, Carlos Rodriguez Valdes-Fauly, MD.

Research ethics committees:

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

Surgical Medical Research Center, October 11, 2007

Recruitment status

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

Recruitment status:

Suspended

Date of first enrollment:

04/10/2008

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:

Patients with diabetic foot ulcer (Wagner grade 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):

One vial (75 ug, 25 ug or placebo, as appropriate) will be administered intralesionally 3 times a week until lesion occlusion or for up to 12 weeks. Vial reconstitution and dilution will be performed using 5 mL of injection water. The product will be spread over the lesion applying 0.5 - 1 mL during each infiltration. When lesion size gets smaller than 1 cm2, the number of injections and the volume to be administered will be determined by researcher, depending on lesion size and resistance.

Intervention code:

Epidermal Growth Factor

Injections, Intralesional

Placebos

Intervention keyword:

RhEGF recombinant human Epidermal Growth Factor

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):

Total lesion occlusion 12 weeks after commencing treatment. The lesion will be considered occluded when epithelization occurs and there is no secretion and need for dressing. This event will show therapeutic success or failure, respectively.

Key secondary outcomes:

Total lesion occlusion at 4th, 8th, 16th, and 20th weeks. Time required for total lesion occlusion. Occlusion in 50% of the initial ulcer area. The number of patients exhibiting 50% of ulcer occlusion at 4th, 8th, 12th, 16th, and 20th weeks will be determined. Time required for 50% lesion occlusion. Development of granular tissue in 90% of lesion area. The number of patients exhibiting this effect at 4th and 8th weeks will be determined. When lesion area is reduced, the granulated and occluded areas are added up, and the percentage based on the area measured before applying the product is calculated. Time required for granular tissue formation in 90% of ulcer area. Systemic EGF concentration after intralesional application.

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) Patients with DM type 1 or 2 under ADA criteria. 2) Patients of both sexes, aged >= 18. 3) Diabetic foot ulcers classified by Wagner as grade 1 covering an area >10 and =50 cm2 or grade 2 covering an 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 not exceed 0.7. 5) Ulcer = 4 week evolution. 6) Reproductive age men and women should use effective contraceptive methods for up to three months after completing treatment. 7) Patients should give their consent.

Exclusion criteria:

1. Infection signs or symptoms. 2. Osteomyelitis or ulcers with bone exposure. 3. Poorly controlled diabetes mellitus (Hb A1c > 10%). 4. Connective tissue diseases. 5. Use of drugs likely to interfere with (corticoids or inmunosuppressors) or to favor cicatrisation (pentoxifylline, prostaglandin and other growth factors) in the previous 3 weeks. 6. Uncontrolled systemic or serious diseases: cardiopathies (acute myocardial infarction < 3 months, unstable angina or heart failure with edema), moderate or serious liver failure, kidney failure with serum creatinine values > 200mmol/L. 7. Clinical malnutrition signs or albumin levels < 30 g/L. 8. 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 intralesional EGF treatment in current lesion or < 4 weeks in any other lesion, or topical EGF < 4 weeks in current lesion. 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:

2

Target sample size:

35

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:

Amaurys

Last Name:

del Río Martín

Specialty:

Doctor of Science

Affiliation:

Center for Genetic Engineering and Biotechnology. (CIGB)

Postal Address:

31st Ave. between 158 and 190, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

amaurys.rio@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 Genetic Engineering and Biotechnology (CIGB).

Postal Address:

31st Ave. between 158 and 190, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

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:

RPCEC00000048

Date of Registration in Primary Registry:

2010-12-24

Record Verification Date:

2014/05/27

Next update date:

2015/05/27

Link to the spanish version:

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Clinical trial, phase II, to evaluate rhEGF efficacy and safety at a dose of 25 or 75 micrograms intralesionally in patients with diabetic foot ulcer (Wagner grade 1 or 2).

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