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EGF in bilateral symmetric diabetic neuropathy
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23 March 2020 - 3:44pm
by Gladys
23 March 2023 - 12:29am
by Gladys
Changes to
Postal address of Ethic Committee
-
Avenida 31 y Calle 114, Marianao,
La Habana
, C.P:11400, Cuba
+
Avenida 31 y Calle 114, Marianao,
Havana
, C.P:11400, Cuba
-
Calle 29 esquina D, Plaza,
La Habana
, C.P:10600, Cuba
+
Calle 29 esquina D, Plaza,
Havana
, C.P:10600, Cuba
-
Calle San Lazaro # 701 esq. a Padre Varela, Centro Habana,
La Habana
, C.P: 10400, Cuba
+
Calle San Lazaro # 701 esq. a Padre Varela, Centro Habana,
Havana
, C.P: 10400, Cuba
-
Calle 216 y 11b, Reparto Siboney, Playa,
La Habana
, C.P:12100, Cuba
+
Calle 216 y 11b, Reparto Siboney, Playa,
Havana
, C.P:12100, Cuba
-
Avenida 31 y Calle 114, Marianao,
La Habana
, C.P:11400, Cuba
+
Avenida 31 y Calle 114, Marianao,
Havana
, C.P:11400, Cuba
Changes to
Control group
-
Dose comparison
+
Uncontrolled
Changes to
Record Verification Date
-
2020/
03
/
23
+
2020/
10
/
21
Changes to
Next update date
-
2021/
03
/
23
+
2021/
10
/
21
Revision of 23 March 2023 - 12:29am:
EGF in bilateral symmetric diabetic neuropathy
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:
Clinical trial with different doses of human recombinant epidermal growth factor, administered subcutaneously and perineurally, in patients with bilateral symmetric diabetic neuropathy.
Secondary indentifying numbers:
IG/FCEI/ND/1927
Issuing authority of the secondary identifying numbers:
Center for Genetic Engineering and Biotechnology (CIGB)
Primary sponsor:
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, Cuba.
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 Drugs, Medical Devices and Equipment (CECMED)
Reference number:
In process
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Carlos
Midle name:
Alberto
Last name:
Gonzalez Delgado
Medical Specialty :
2nd grade specialist in Clinical Pharmacology
Affiliation:
National Center for Toxicology (CENATOX)
Postal address:
Avenida 31 y Calle 114, Marianao
City:
Havana
Country:
Cuba
Zip Code:
11400
Telephone:
+53-72743282
Email address:
eclinicos@infomed.sld.cu
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, Institute of Neurology and Neurosurgery, Norge Santiesteban Velazquez, 2nd degree Specialist in Neurology.
Havana, "Hermanos Ameijeiras" Hospital, Yaser Estrada Napoles, 1st degree Specialist in Pathological Anatomy.
Havana, Surgical Medical Research Center, Yolanda Cruz Gomez, Master in Clinical Laboratory.
Havana, "Carlos J. Finlay" Hospital, Joan Laffita Zamora, 1st Grade Specialist in Anesthesia and Resuscitation.
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Pending
Date of first enrollment:
04/05/2020
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:
Bilateral symmetric diabetic neuropathy
Health condition(s) code:
Diabetic Neuropathies
Diabetes Complications
Diabetes Mellitus
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Intervention(s):
Group I-Experimental: 8.3 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, 10 cm proximal to the internal and external ankle malleolus, 3 times per week for up to 8 weeks. Group II-Experimental: 8.3 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, perineurally before bifurcation of the sciatic nerve, 3 times per week for up to 8 weeks. Group III-Experimental: 25 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, 10 cm proximal to the internal and external ankle malleolus, 3 times per week for up to 8 weeks. Group IV-Experimental: 25 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, perineurally before bifurcation of the sciatic nerve, 3 times per week for up to 8 weeks. Group V-Experimental: 75 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, 10 cm proximal to the internal and external ankle malleolus, 3 times per week for up to 8 weeks. Group VI-Experimental: 75 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, perineurally before bifurcation of the sciatic nerve, 3 times per week for up to 8 weeks.
Intervention code:
Epidermal Growth Factor
Drug Administration Routes
Injections, Subcutaneous
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):
Serious Adverse Events (SAE). They will be measured as: -SAE occurrence (Yes, No), -SAE description (name of the event), -Causality relationship (probable or definitive), -Measures taken (None, Administration of any pharmacological therapy, Addition of a therapy Non-pharmacological, Exit from the study, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event). Measurement time: three times a week for 8 weeks.
Key secondary outcomes:
Clinical response: a) Criteria of the patient about his pain (reduction or not of the parameter, in number, through the Brief Inventory of pain scale, and the MICHIGAN scale). Measurement time: on inclusion, weekly for 8 weeks. b) Pain response criteria (percentage of pain reduction according to the Mc Gill pain questionnaire). Measurement time: at inclusion, weekly for 8 weeks; c) Drug reduction criteria for neuropathic pain (number of drugs administered for pain); Measurement time: at inclusion, weekly for 8 weeks; d) motor and sensory neuroconduction of the sural and peroneal nerves (distal latency, amplitude, conduction velocity). Measurement time: on inclusion, weekly for 8 weeks. Pharmacokinetic evaluation: Pharmacokinetic profile (Area under the curve, Plasma clearance, Apparent volume of distribution at steady state, Average lifetime, Average residence time). Measurement time: After administration of the FCEhr in its first dose. Adverse clinical events not related to research products (AE). They will be measured as: - AE occurrence (Yes, No), - AE description (event name), - Intensity of the AE (mild, moderate, severe), - Causality ratio (not related, doubtful, possible), - Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit from the study, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and invariant, Worsening , Death caused by this event). Measurement time: three times a week for 8 weeks.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
40 years
Maximum age:
60 years
Inclusion criteria:
1) Voluntariness of the patient by granting written informed consent. 2) Diabetic patients with a diagnosis of diabetic neuropathy 2. 3) Body mass index less than or equal to 35. 4) Age between 40 and 60 years, both inclusive. 5) Glycosylated hemoglobin less than or equal to 10%. 6) Diabetes mellitus type 2 controlled or with blood glucose up to 10 mmol / L. 7) Patients with more than 6 months of pain treatment. 8) Normal values in serum protein electrophoresis 9) Normal values of T4 and TSH. 10) Normal values of vitamin B12. 11) Test for negative celiac disease.
Exclusion criteria:
1129/5000 1) Presence of infection or ulcer of the diabetic foot. 2) Presence of chronic peripheral stigmas of arterial insufficiency. 3) Normal neuroconduction parameters: between 10 and 15 microvolt amplitude. 4) Any painful condition that makes it difficult to distinguish pain from bilateral symmetric diabetic neuropathy. 5) Uncompensated or severe systemic diseases: heart disease (acute myocardial infarction in the previous 3 months, unstable angina or heart failure with edema), moderate or severe hepatic insufficiency, renal insufficiency with creatinine values greater than 200 micromol / L. 6) Other types of neuropathy and those that concur with diabetic neuropathy. 7) Hemoglobin less than 10 g / L. 8) Hypersensitivity to the product or to any of its components. 9) History of current or past malignancy. 10) Psychiatric or neurological diseases that prevent the patient from granting consent. 11) Confirmed pregnancy or women in pregnancy plan or who do not use contraceptives. 12) History of alcoholism in the last two months. 13) Impossibility of attending the planned evaluations.
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:
Uncontrolled
Study design:
Parallel
Phase:
1-2
Target sample size:
48
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 Rio Martin
Specialty:
1st grade specialist in Comprehensive General Medicine and Immunology.
Affiliation:
Center for Genetic Engineering and Biotechnology (CIGB).
Postal Address:
Ave. 31 entre 158 y 190, Cubanacan, Playa.
City:
Havana
Country:
Cuba
Zip Code:
10600
Telephone:
+53-72085887, 72087465
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:
Amaurys
Last Name:
del Río Martín
Specialty:
1st grade specialist in Comprehensive General Medicine and Immunology.
Affiliation:
Center for Genetic Engineering and Biotechnology (CIGB).
Postal Address:
Ave. 31 entre 158 y 190, Cubanacan, Playa.
City:
Havana
Country:
Cuba
Zip Code:
10600
Telephone:
+53-72085887, 72087465
Email :
amaurys.rio@cigb.edu.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
National Toxicology Center
Institute of Neurology and Neurosurgery
"Hermanos Ameijeiras" Surgical Clinical Hospital
Surgical Medical Research Center
"Carlos J. Finlay" Hospital
Status of evaluation:
approved
approved
approved
approved
approved
Status of evaluation date of Ethic Committee:
28/11/2019
30/10/2019
11/11/2019
20/02/2020
28/11/2019
Postal address of Ethic Committee :
Avenida 31 y Calle 114, Marianao, Havana, C.P:11400, Cuba
Calle 29 esquina D, Plaza, Havana, C.P:10600, Cuba
Calle San Lazaro # 701 esq. a Padre Varela, Centro Habana, Havana, C.P: 10400, Cuba
Calle 216 y 11b, Reparto Siboney, Playa, Havana, C.P:12100, Cuba
Avenida 31 y Calle 114, Marianao, Havana, C.P:11400, Cuba
Telephone:
53- 72743282
53-78381820
53- 78761210
53-78581000
53-72743000
Email:
eclinicos@infomed.sld.cu
dirinn@infomed.sld.cu
yaser@infomed.sld.cu
ycruz@infomed.sld.cu
joan@infomed.sld.cu
About study completion
Section to complete the data related to the study completion.
Final enrolment number:
0
Study completion date:
03/08/2021
Date of available results:
15/12/2021
Date of first publication:
02/05/2022
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:
RPCEC00000305
Date of Registration in Primary Registry:
23/03/2020
Record Verification Date:
2020/10/21
Next update date:
2021/10/21
Link to the spanish version:
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