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IRCT20240116060710N1 IRCT 2024-02-02 Shahid Beheshti University of Medical Sciences Evaluation the effect of Botulinium toxin injection on improving symptoms in patients with diabetic neuropathy Evaluation the effect of Botulinum toxin type A Masport 500 injection on improving pain and quality of life in patients with diabetic neuropathy. 2024-02-20 anticipated 30 Complete https://irct.ir/trial/75038 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Dividing patients into case and control groups based on the block randomization method for all patients in the case and control groups, Blinding description: In this clinical trial study, 30 patients with diabetic neuropathy confirmed by electrodiagnostic study and with symptoms of diabetic neuropathy will be included in the study. For the random allocation of people in the study groups (intervention group and control group) using the random allocation or block method randomization will be used. In this method, blocks of 6 (including three people in the intervention group and 3 people in the control group) will be used with a ratio of 1:1. Random Allocation software will be used to generate random sequences. Random allocation concealment method will be used, in this way that the random sequences created in this method, which are identified by the letters a (intervention group) and b (control group), will be recorded on cards and these cards will be sealed inside the envelope. will be placed in order. In order to preserve the created sequence, numbering will also be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder, then according to the order of arrival of the eligible participants, the envelopes will be opened and The assigned group of that participant will be determined. 3 Diabetic neuropathy. Intervention 1: After covering the perianal bilateral surface of the foot and the front of the ankle with 2% lidocaine ointment, a total of 240 units of botulinum toxin A must be administered (120 units per foot) once intradermal injection in 6 places on the perianal surface of the foot and the front of the ankles(12 points). Intervention 2: Control group: After covering the perianal surface of the foot and the front of the ankle on both sides with 2% lidocaine ointment, the same amount(240 unit toxin) of normal injectable saline 0.9% is injected intradermally in the same points (6 points 12 points total) on the perianal surface of the foot and ankles. Yes - There is a plan to make this available What will be shared: All the data of people participating in the study can be shared after de-identifying people. When: The access period starts one year after the results are published. To whom: The data of this study will be available to researchers working in academic and scientific institutions. Conditions: If the goal of the researchers is to perform a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers. Where to obtain: by sending an e-mail to yasimalekztaher@gmail.com How to obtain: Sending an email requesting information and explaining the purpose and method of using data. Comments:
public Yasaman malekzade
Mahdiye Hospital Fadaeiane Eslam St ,Shosh squre , Tehran ,Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 yasimalekztaheri@gmail.com Shahid Beheshti University of Medical Sciences scientific Masume Bayat
Mahdiye Hospital Fadaeiane Eslam St ,Shosh squre , Tehran ,Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 yasimalekztaheri@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Definite diabetic neuropathy in the plantar area of ​​both feet confirmed by NCV. diabetes at least for three years Consistency of the patient's medication for diabetic neuropathy for at least one month before entering the study Filling out a personal consent form to enter the study no limit no limit Both Having an underlying disease involving the peripheral nerves that causes symptoms similar to diabetic neuropathy in the plantar area. Change in the patient's medication for diabetic neuropathy during at least one month before entering the study History of myasthenia gravis Allergy to botulinum toxin kidney dysfunction Having a history of alcohol consumption Opioid addiction Presence of pain with a typical dermatomal pattern caused by radiculopathy Lack of patient consent to participate in the study Rehabilitation Rehabilitation After covering the perianal bilateral surface of the foot and the front of the ankle with 2% lidocaine ointment, a total of 240 units of botulinum toxin A must be administered (120 units per foot) once intradermal injection in 6 places on the perianal surface of the foot and the front of the ankles(12 points) Control group: After covering the perianal surface of the foot and the front of the ankle on both sides with 2% lidocaine ointment, the same amount(240 unit toxin) of normal injectable saline 0.9% is injected intradermally in the same points (6 points 12 points total) on the perianal surface of the foot and ankles Pain and quality of life and sleep quality of patients. Timepoint: at the begining of the study and in 1-4-8-12 week after intervention. Method of measurement: Evaluation of changes in scores of VAS, PSQI, SF-36 questionnaires. Masoon darou Approved 2024-02-20 Research ethics committee of Shahid Beheshti univercity of medical sciences Shahid Beheshti university of medical sciennce ,Yaman Street ,Chamran highway ,Velenjak Tehran, Iran Tehran Tehran Iran (Islamic Republic of)