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IRCT201308223213N1 IRCT 2013-10-03 Diabetes Research Center/Institute of Endocrinology and Metabolism/Tehran University of Medical Scie Effect of transcutaneous nitroglycerin on painful diabetic neuropathy The effect of transdermal nitroglycerin on pain control of painful peripheral diabetic neuropathy: A crossover, double-blinded and placebo-controlled study 2012-04-24 anticipated 30 Complete https://irct.ir/trial/3267 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive. N/A Diabetic polyneuropathy. Intervention 1: In the study group the patients will be asked to apply 0.2 mg/hr transcutaneous nitroglycerin plasters ( Nitro-Dur, Schering-Plough Pty Ltd., Australia) for 12 hours daily and for 4 weeks. Intervention 2: In the placebo group the patients will be asked to apply transcutaneous placebo plasters for 12 hours daily and for 4 weeks.
public Arash Farbood
Anesthesiology Department, Faghihi Hospital, Zand Avenue
Shiraz Iran (Islamic Republic of) +98 71 1233 7636 farboda@sums.ac.ir; arashfarbood@yahoo.com Shiraz University of Medical Sciences scientific Arash Farbood
Anesthesiology Department, Faghihi Hospital, Zand Avenue
Shiraz Iran (Islamic Republic of) +98 71 1233 7636 farboda@sums.ac.ir ; arashfarbood@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: more than 18 years of age ; history of type 1 or 2 diabetes ; Hb A1c level below 8.5% ; symptoms of symmetrical peripheral neuropathy in distal lower extremities ; pain severity more than 4 of 10 in NRS scale at the begining of the study ; the patients` willingness, knowledge and ability for participation Exclusion criteria: patients with ischemic heart and lower extremity peripheral arterial disease ; patients with diabetic foot ulcers ; patients with history of peripheral neuropathies from other causes (e.g. hypothyroidism, vitamin B12 or folate deficiency, sarcoidosis and alcoholism) ; patients who receive vasodilating compounds like nitroglycerine and sildenafil no limit no limit Both G63.2 Diabetic polyneuropathy Treatment - Drugs Placebo In the study group the patients will be asked to apply 0.2 mg/hr transcutaneous nitroglycerin plasters ( Nitro-Dur, Schering-Plough Pty Ltd., Australia) for 12 hours daily and for 4 weeks. In the placebo group the patients will be asked to apply transcutaneous placebo plasters for 12 hours daily and for 4 weeks. Pain intensity. Timepoint: 2 times weekly. Method of measurement: Numerical Rating Scale. Patient`s physical functioning. Timepoint: Once after each phase of treatment (with drug and placebo). Method of measurement: SF-36 and BPI questionnaires. Psychological and emotional status of the patients. Timepoint: Once after each phase of treatment (with drug and placebo). Method of measurement: BDI. Patient`s global satisfaction and sense of well-being. Timepoint: Once after each phase of treatment (with drug and placebo). Method of measurement: PGIC questionnaire. Frequency and severity of treatment related side effects. Timepoint: Once a week during the treatment phases. Method of measurement: Frequency and severity measurement. Diabetes Research Center/Institute of Endocrinology and Metabolism/Tehran University of Medical Scie Approved 2011-08-27 Diabetes Research Center/Institute of Endocrinology and Metabolism/Tehran University of Medical Scie Diabetes Research Center, 5th floor, Diabetes and Metabolic Disease clinic, next to the Tehran Heart Center Emergency Department, Heyaat Alley, Western 17th Shahrivar Avenue, Northren Kargar Street, Amirabad Tehran Iran (Islamic Republic of)