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IRCT20130518013364N8 IRCT 2019-11-29 Shahid Beheshti University of Medical Sciences The effect of intradermal Dysport injections on painful diabetic polyneuropathy The effect of intradermal Dysport injections on painful diabetic polyneuropathy 2019-05-05 anticipated 141 Complete https://irct.ir/trial/43668 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomly assigned to one of three groups using the simple random sampling with substitution with the help of a random numbers table (Kendall & Smith table), Blinding description: The physician who injects the drug solutions and the one who evaluates the patients in follow-up visits, are different and are blind to the subject. Patients are not aware of injectable drugs. 2-3 Condition 1: Diabetic polyneuropathy. Condition 2: Diabetic polyneuropathy. Intervention 1: First intervention group: group D1, 150 units BTX- A solved in 2 ml saline normal 0.9%, injected in 20 points of right foot of patients intradermally and in left foot in 20 points saline normal 0.9% are injected intradermally. Intervention 2: Second intervention group: group D2, 150 unites of BTX- A solved in 4 ml saline normal 0.9% for each foot 75 units botulinum toxin A in 20 points of soles of each patient injected intradermally. Intervention 3: Control group: group N, in 20 points of sole of each patient with 1 cm from each other and in each point 10 units of insulin syringe of saline normal 0.9% is injected. Yes - There is a plan to make this available What will be shared: Information on the initial implications When: Since 2020 To whom: Researchers working in academic institutions Conditions: There are no special conditions Where to obtain: Mehrdad Taheri taheri.1352@yahoo.com How to obtain: Send a request by e-mail Comments:
public Mehrdad Taheri
Shahid Madani street-Imam Hossein Hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 m.taheri@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mehrdad Taheri
Shahid Madani street-Imam Hossein Hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 m.taheri@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) diabetic type I or II bilateral symmetric distal polyneuropathy based on the Douleur Neuropathique 4 (DN4) questionnaire and Nerve conduction velocity (NCV) aged between 40 and 70 years old 40 years 70 years Both local infection in lower limbs lumbar radiculopathy neurologic or mental deficit allergy to the botulinum toxin or used NSAIDs or other medications to alleviate the neuropathic pain history of alcohol or opium consume renal disease muscular weakness or atrophy of lower limb history of myasthenia gravis use of aminoglycosides breastfeeding mothers E10.42 E11.42 Type 1 diabetes mellitus with diabetic polyneuropathy Type 2 diabetes mellitus with diabetic polyneuropathy Rehabilitation Rehabilitation Placebo First intervention group: group D1, 150 units BTX- A solved in 2 ml saline normal 0.9%, injected in 20 points of right foot of patients intradermally and in left foot in 20 points saline normal 0.9% are injected intradermally Second intervention group: group D2, 150 unites of BTX- A solved in 4 ml saline normal 0.9% for each foot 75 units botulinum toxin A in 20 points of soles of each patient injected intradermally. Control group: group N, in 20 points of sole of each patient with 1 cm from each other and in each point 10 units of insulin syringe of saline normal 0.9% is injected. Pain. Timepoint: 4 weeks. Method of measurement: VAS. Neuropathy Pain Scale (NPS). Timepoint: 4 weeks. Method of measurement: Scores are based on patients responses to questions (NPS). Shahid Beheshti University of Medical Sciences Approved 2019-04-30 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences Tehran Tehran Iran (Islamic Republic of)