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IRCT20191221045837N5 IRCT 2023-09-09 Mashhad University of Medical Sciences Evaluating the effectiveness of silver spray in scleroderma Evaluating the effectiveness of nano silver spray on digital ulcers of patients with scleroderma 2023-12-22 anticipated 50 Complete https://irct.ir/trial/72415 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization Randomization tool: https://www.sealedenvelope.com/ How to make a random sequence: To perform this method, the number of intervention groups (two groups A and B), the volume of each block (4 in each block) and sample size (50 patients) were entered into the website. Then, the site creates a randomization list of 13 blocks, each contains 4 patients, Blinding description: The study is double blinded in which the subjects, evaluators, analysts, sample allocators will be unaware of the intervention and control groups. Drugs and placebo, numbered 1-50, will be identified and distinguished by the drug manufacturing company, which belong to the drug or placebo group based on a random list prepared from www.sealedenvelope.com. The physician, patients, and analyst will remain unaware of the type of formulation until the work is completed. Patients receive one of the medicine containers, number 1-50, respectively. The list will be decrypted when completed. 2-3 scleroderma. Intervention 1: Intervention group: In the intervention group, patients use silver nanospray 4 times a day (every 6 hours) on the finger ulcers. Intervention 2: Control group: In the control group, patients use placebo spray 4 times a day (every 6 hours) on the finger ulcers. Yes - There is a plan to make this available What will be shared: At the end of study, all medical records of patients will be shared. When: The access period starts 6 months after the publication. To whom: Researchers affiliated to academic, scientific and industrial institutes Conditions: No one is allowed to use the documents except the principal researcher. Where to obtain: Send an email to Dr. Zinat Heidari. heidarizn@mums.ac.ir How to obtain: Send an email to Dr. Zinat Heidari. heidarizn@mums.ac.ir Comments:
public Zinat Heidari
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1584 heidarizn@mums.ac.ir Mashhad University of Medical Sciences scientific Zinat Heidari
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1584 heidarizn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 1. Patients aged > 18 years 2. Patients with finger ulcers, caused by scleroderma, with mild to moderate severity (1-10 new ulcers in the fingers involving surface epithelial cells, the epidermis, the dermis, or the subcutaneous tissue) and without purulent discharge 3. Patients who signed our patient consent permission form. 18 years no limit Both 1. Patients with severe finger ulcers (more than 10 new ulcers in the fingers, extensive tissue destruction with damage to muscle, supporting structures (eg, tendon, joint capsule) and bone, necrosis and gangrene) Patients who do not use the spray regularly M34 Systemic sclerosis [scleroderma] Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, patients use silver nanospray 4 times a day (every 6 hours) on the finger ulcers. Control group: In the control group, patients use placebo spray 4 times a day (every 6 hours) on the finger ulcers. The size of ulcers. Timepoint: weekly. Method of measurement: Length x Width: Measure the greatest length (head to toe) and the greatest width (side to side) using a centimeter ruler. (DUS) digital ulcer score. Timepoint: weekly. Method of measurement: Length x depth of ulcer. The healing time of ulcers. Timepoint: weekly. Method of measurement: Observing the appearance of the ulcer. Intensity of pain in patients with ulcers. Timepoint: weekly. Method of measurement: visual analogue scale (VAS). The quality of life of patients. Timepoint: weekly. Method of measurement: Health-Related Quality of Life (HRQOL) questionnaire. Mashhad University of Medical Sciences Approved 2023-08-19 Ethics committee of Mashhad University of Medical Sciences Central department of Mashhad University of Medical Sciences, next to Alton Tower, Daneshgah Street, Mashhad, Khorasan Razavi Province, Iran. Mashhad Razavi Khorasan Iran (Islamic Republic of)