Clinical trial with different doses of human recombinant epidermal growth factor, administered subcutaneously and perineurally, in patients with bilateral symmetric diabetic neuropathy.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 48 人开始时间: 2020年3月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment

•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.

•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.

发起方

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