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IRCT20160514027888N3 IRCT 2023-04-17 Semnan University of Medical Sciences Cutaneous Leishmaniasis Wound Healing with Cold Plasma Investigating the effect of using atmospheric cold plasma radiation to heal wound healing in cutaneous leishmaniasis 2023-06-22 anticipated 142 Complete https://irct.ir/trial/68455 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The second phase of the clinical trial is on a group of 142 people since the list of patients is not known in advance and the number of patients is not known. A total of 71 subjects were obtained for each treatment. In case of reaching 71 people in the plasma or standard group, the treatment that has been completed is stopped and the only treatment that still needs patients (71 patients) is performed on people, Blinding description: In the first group, plasma devices are used in the state where the gas flow is on and the patient will feel the gas flow, and in the second group, standard treatment with plasma radiation during 10 alternating sessions, the patient's wound with plasma radiation with a duration of 2 The minute is swept away. The condition of the wound is checked every week during the treatment, and when the wound is completely healed, the treatment is stopped, and the patient's condition will be followed up to one month later. N/A Cutaneous leishmaniasis. Intervention 1: Control group: The standard treatment of Salk includes injection of glucantim ampoules. Intervention 2: Intervention group: Standard treatment along with plasma radiation during 10 alternating sessions. Yes - There is a plan to make this available What will be shared: Publication of scientific research articles and ISI When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Checking the effectiveness of the treatment process Where to obtain: Dr. Mohammad Reza Khani, member of the faculty of Shahid Beheshti University, 09122531497 How to obtain: The request will be sent via email to m_khani@sbu.ac.ir and will be answered within 30 working days after review. Comments:
public Abolfazl Fattah
After Islamic Azad University، Cheshme Ali Blvd
Damghan Iran (Islamic Republic of) 3671637881 +98 23 3522 5120 Drabolfazlfatah@gmail.com Semnan University of Medical Sciences scientific Abolfazl Fattah
After Islamic Azad University, Cheshme Ali Blvd
Damghan Iran (Islamic Republic of) 3671637881 +98 23 3522 5120 Drabolfazlfatah@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) No history of radiation therapy. Not taking chemotherapy drugs. Not taking drugs that suppress the immune system. Not having a severe infection that requires hospitalization. Not having a severe bone infection Lack of breastfeeding. 18 years no limit Both B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Devices Control group: The standard treatment of Salk includes injection of glucantim ampoules Intervention group: Standard treatment along with plasma radiation during 10 alternating sessions Changes in wound area and wound infection rate. Timepoint: Before treatment, after two weeks and at the end of treatment. Method of measurement: Imaging and microbial culture. Semnan University of Medical Sciences Approved 2022-10-10 Ethics Committee of Semnan University of Medical Sciences Basij Boulevard, University of Medical Sciences and Health Services Semnan Semnan Iran (Islamic Republic of)