]>
IRCT20150927024228N3 IRCT 2020-10-22 Kerman University of Medical Sciences Evaluation of leech therapy in diabetic neuropathy of lower limbs Evaluation of leech therapy in diabetic neuropathy of lower limbs 2020-08-04 anticipated 40 Complete https://irct.ir/trial/50237 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done in a simple way using a table of random numbers. Among the numbers 1 to 40, 20 random numbers are selected from this table for the leech therapy and the rest (of the patients) are assigned to the standard treatment group. Patients are not known in advance. In this way, the order of entering the groups is determined: for example, it is pre-determined and it is written in the envelopes, for example, which group the 5th, 30th or 40th person will be in. When each person enters the study, an envelope is opened and the treatment group is determined for him. Sorting is done using a table of random numbers. some envelopes are provided according to the number of samples and the type of treatment is written in each envelope. We start reading from a point on the table of random numbers vertically and in two digits two digits. If the read number was between 01 and 40, the number is assigned to the leech therapy group. We will continue this work until we reach the number of samples in this group (20 people). the envelopes are closed and sealed and a three-digit code is written on each of them. the order of the envelopes is determined by a statistician. after the patient enters the study and completes the informed consent form, an envelope is opened and the type of treatment is determined; then the patient receives the treatment. 3 Diabetic neuropathy. Intervention 1: In the leech treatment group, three to five medical leeches, six to eight centimeters in size, are thrown in three steps every fifteen days in the area of the back of the feet, tangentially from the root of the second toe to the external malleolus. Intervention 2: In the control group, patients are given 300 mg of gabapentin capsule as a single dose at night before going to bed for 30 days. Yes - There is a plan to make this available What will be shared: After the study, information about the main outcome will be shared. When: 12 months after printing To whom: All researchers can get it. Conditions: Data and results will be available to all researchers for research on diabetic neuropathy. Where to obtain: dr.azimm@gmail.com How to obtain: The data will be provided to the applicant within one month after reviewing and confirming the application. Comments:
public Farshad Alami
Nasiraei8, Sardaran 9, Sheikh Tabarsi Street
Babol Iran (Islamic Republic of) 4713937679 +98 11 3229 2492 farshad.alami1700@gmail.com Kerman University of Medical Sciences scientific Maryam Azimi
Amirkabir Crossroad, Jomhuri Boulevard, Kerman
kerman Iran (Islamic Republic of) 7616913555 +98 34 3211 0123 Dr.azimm@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Having informed consent Age 30 years and above Type 2 diabetes with the approval of an endocrinologist Having diabetic neuropathy based on nerve and muscle tape The patient should not use other drugs that are effective on neuropathy at the same time No pregnancy No breastfeeding No other diseases that cause neuropathy such as alcohol, vitamin B12 deficiency, chemotherapy, kidney failure, nerve compression, autoimmune disease, infection, Guillain-Barre syndrome 30 years no limit Both Having a diabetic foot ulcer requires surgery Use of anticoagulants such as heparin, warfarin, etc Any coagulation disease History of hospitalization due to cardiovascular disease History of major mental disorders Not taking painkillers, or common drugs for neuropathy treatment during the last month Anemia E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified Other Treatment - Drugs In the leech treatment group, three to five medical leeches, six to eight centimeters in size, are thrown in three steps every fifteen days in the area of the back of the feet, tangentially from the root of the second toe to the external malleolus. In the control group, patients are given 300 mg of gabapentin capsule as a single dose at night before going to bed for 30 days. Burning sensation. Timepoint: At the beginning of the study, days 15, 30 and 45 of the beginning of the study. Method of measurement: Using Visual Analogue Scale and Neurophathy Symptom Score questionnaires. Intensity of pain. Timepoint: At the beginning of the study, days 15, 30 and 45 of the beginning of the study. Method of measurement: Using Visual Analogue Scale and Neurophathy Symptom Score questionnaires. Tingling. Timepoint: At the beginning of the study, days 15, 30 and 45 of the beginning of the study. Method of measurement: Visual Analogue scale and neuropathy symptom score questionnaire. Muscle weakness and cramps. Timepoint: At the beginning of the study, days 15, 30 and 45 after the start of the study. Method of measurement: Neoropathy Symptom Score questionnaire. Vibration in the big toe. Timepoint: At the beginning of the study, days 15, 30 and 45 after the start of the study. Method of measurement: Neurophathy Disability Score questionnaire. Recognize the feeling of cold and heat in the back of the legs. Timepoint: At the beginning of the study, days 15, 30 and 45 after the start of the study. Method of measurement: Neurophathy Disability Score questionnaire. Detect sharp and blunt bodies on the big toe. Timepoint: At the beginning of the study, days 15, 30 and 45 after the start of the study. Method of measurement: Neurophathy Disability Score questionnaire. Presence or absence of Achilles reflex. Timepoint: At the beginning of the study, days 15, 30 and 45 after the start of the study. Method of measurement: Neurophathy Disabilities score questionnaire. Possible repair of foot nerves in its treatment with leeches. Timepoint: Before the start of the study and 45 days after the start of the study. Method of measurement: Nerve conduction velocity. Possible repair of foot nerves in drug treatment. Timepoint: Before the start of the study and 45 days after the start of the study. Method of measurement: Nerve conduction velocity. Kerman University of Medical Sciences Approved 2020-08-04 Ethics Committee of Kerman University of Medical Sciences Shafa Crossroad, Jomhuri Boulevard, Kerman Kerman Kerman Iran (Islamic Republic of)