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IRCT20211203053262N1 IRCT 2022-09-19 Tehran University of Medical Sciences Evaluation of the effectiveness of ND yag laser on small vascular lesions on lower limb with different energy and pulse duration A comparative investigation of therapeutic effect ND yag laser on small vascular lesions on the lower limbs with energy of 160-180 and pulse duration of 50 with respect to energy 120-140 and pulse duration 10 2022-06-04 anticipated 37 Complete https://irct.ir/trial/63740 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Blocks 4, 6 and 8, in which there are equal numbers of each group in each block, are used to create a balance in the number of assigned samples of each of the studied groups. Randomization unit: Cluster. For this purpose, people are clustered in groups, then sampled from clusters, and it is used when it is possible to select a group of people and it is easier than selecting people in one The community is defined. We do not have random layering. Randomization tool: statistical software SAS(Statistical Analysis System) Random allocation concealment prevents the disclosure of a random sequence so that the assigned group is not specified prior to the individual allocation. This study is two-blind (patient, assessor, statistical analyzer), Blinding description: ِDouble blind: Participant, Data analyzer, Assessor The participant will not be informed of the result of the assessor and statistical analyzer during the study. The analyzer does not know how to divide the two groups and the type of treatment. The assessor does not know how to divide the two groups and the type of treatment. N/A lower limb vascular lesions. Intervention 1: Intervention group: Vascular lesions of less than 3 mm of the lower limb are treated by laser ND yag with energy 160-180 and pulse duration 50 during 0&2 months . Intervention 2: Control group: Vascular lesions of less than 3mm of the lower limb are treated by laser ND yag with energy 120-140 and pulse duration10 during 0 &2 months. Yes - There is a plan to make this available What will be shared: All patient information can be shared without mentioning the name. When: From 6 months after the end of the study until forever To whom: Researchers, experts in the field of laser industry and Dermatologists Conditions: For scientific studies and therapeutic applications Where to obtain: medical University Tehran How to obtain: By sending an email to Tehran university of Medical sciences and after reviewing the action is done Comments:
public Ehsan Rostami
No. 17, Abadi street, north Nabard, Piroozi, Tehran town
Tehran Iran (Islamic Republic of) 1766637531 0021 77164487 EsiRost65@yahoo.com Tehran University of Medical Sciences scientific Ehsan Rostami
No.17, Abadi street, north Nabard, Piroozi, Tehran town
Tehran Iran (Islamic Republic of) 1766637531 +98 21 7716 4487 EsiRost65@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Intact perforating & deep vessels in ultrasound No active infection of the laser area signing an inform consent No history of arterial & venous thrombosis of the lower extremities The Presence of vascular lesions <3 mm having a vascular lesion both above and below the knee No history of liver cirrhosis No history of laser and sclerotherapy in the area in the last 6 months No history of sunburn No consumption ocp no limit no limit Both Treatment - Other Treatment - Other Intervention group: Vascular lesions of less than 3 mm of the lower limb are treated by laser ND yag with energy 160-180 and pulse duration 50 during 0&2 months . Control group: Vascular lesions of less than 3mm of the lower limb are treated by laser ND yag with energy 120-140 and pulse duration10 during 0 &2 months. Vascular lesions recovery rate. Timepoint: Before laser onset, 2 months later, 4 months after initial examination. Method of measurement: Caliper, photography. 1. Help improve superficial varicose veins and prevent them from becoming deep varicose veins 2.Giving a better appearance to patient,s feet 3. Reduce patient anxiety and improve quality of life. Timepoint: Onset, 2 months later, 4 months later. Method of measurement: Photography, caliper. Tehran University of Medical Sciences Approved 2021-01-25 Ethics committee of Tehran University of Medical Sciences No. 533, Razi Dermatology Hospital, Vahdat Islami St., Tehran town Tehran Tehran Iran (Islamic Republic of)