Diabetic polyneuropathy. Diabetic polyneuropathy
Conditions
Interventions
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 we
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.
Sponsors
Diabetes Research Center/Institute of Endocrinology and Metabolism/Tehran University of Medical Scie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity. Timepoint: 2 times weekly. Method of measurement: Numerical Rating Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArash Farbood
Shiraz University of Medical Sciences
Outcome results
None listed