Bilateral symmetric diabetic neuropathy
Conditions
Interventions
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.
Epidermal Growth Factor
Drug Administration Routes
Injections, Subcutaneous
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactAmaurys del Rio Martin
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed