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IRCT20181002041205N2 IRCT 2023-09-12 Rasht University of Medical Sciences The effect of atmospheric pressure cold plasma in patients with diabetic foot ulcer Comparison of the efficacy of cold atmospheric plasma and common treatment in diabetic patients with foot ulcer 2023-10-02 anticipated 52 Complete https://irct.ir/trial/72513 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: using block, randomization unit: individual, randomization tool: Random Allocation software. The randomization tool in this study will be Random Allocation software, this software is capable of creating random sequences using the block method.In order to hide the allocation in this research, random allocation concealment is used, which refers to the method used to perform a random sequence on the participants in the study, in such a way that the allocated group is not known before the allocation of the individual.The intended method is to use sealed opaque letter envelopes with a random sequence. In this method, each random sequence created is recorded on a card and the cards are placed inside the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box . At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: Patients in this study are blinded and are not aware of receiving placebo or plasma treatment for the purpose of blinding. N/A Diabetic Foot Ulcer. Intervention 1: Intervention group: The intervention group in this study will receive all the standard care for diabetic foot ulcers, which includes the prescription of appropriate antibiotics (if possible, the same antibiotics are used in the test and control groups), blood sugar control, and site care. wound (intermittent washing, dressing, debridement, and patient education). In the intervention group, each wound is treated with cold plasma three times a week and for two minutes each time (according to the recommendation of the manufacturer of the device) during 2 weeks (6 sessions). Cold plasma will be produced by DBD plasma device where plasma is created by electric discharge with dielectric barrier. Intervention 2: Control group: The control group in this study includes patients with diabetic foot ulcers who will receive all the standard care of diabetic foot ulcers, included proper antibiotics, glycemic control, and local wound care Also, each wound is treated three times a week for two minutes during 2 weeks (6 sessions) with a placebo, which is the probe of the inactive plasma device along with the pre-recorded sound of the device. Yes - There is a plan to make this available What will be shared: Data collected for the primary and secondary outcome measurements . When: startting 12 month after publication until 5 years later To whom: researchers working in academic and scientific institutions Conditions: Use of data and documentation is not allowed in any article, thesis, etc. Where to obtain: The person requesting to receive the documents can contact the person in charge of scientific accountability and general accountability of the project via email. Scientific accountability: Dr. Fatemeh Jafar Aghaee jafaraghaee@gums.ac.ir General answer: Nima Rafiee Liavoli liavolnima2015@gmail.com How to obtain: By sending an email, it can receive data. Comments:
public Nima Rafiee
Daneshju Ave, Hamidian, Shahidbeheshti Highway, Rasht
Rasht Iran (Islamic Republic of) 41469-39814 +98 13 3355 3202 liavolnima2015@gmail.com Rasht University of Medical Sciences scientific Fatemeh Jafaraghaee
Daneshju Ave, Hamidian, Shahidbeheshti Highway, Rasht
Rasht Iran (Islamic Republic of) 41469-39814 +98 13 3355 5058 jafaraghaee@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) age range from 18 to 80 years having type 1 or type 2 diabetes having a grade 1 or 2 wound in the lower limb based on the Wagner scale 18 years 80 years Both having a hemoglobin A1C higher than 10%. simultaneous use of other treatment methods such as vacuum therapy, maggot therapy, PRP or platelet-rich plasma. pregnant and lactating women. a history of cancer. under Being treated with chemotherapy drugs or immunosuppressive drugs. having artificial pacemakers. having a history of epilepsy . participating in other studies are concurrent. E11.5 Type 2 diabetes mellitus with circulatory complications Treatment - Devices Treatment - Devices Intervention group: The intervention group in this study will receive all the standard care for diabetic foot ulcers, which includes the prescription of appropriate antibiotics (if possible, the same antibiotics are used in the test and control groups), blood sugar control, and site care. wound (intermittent washing, dressing, debridement, and patient education). In the intervention group, each wound is treated with cold plasma three times a week and for two minutes each time (according to the recommendation of the manufacturer of the device) during 2 weeks (6 sessions). Cold plasma will be produced by DBD plasma device where plasma is created by electric discharge with dielectric barrier. Control group: The control group in this study includes patients with diabetic foot ulcers who will receive all the standard care of diabetic foot ulcers, included proper antibiotics, glycemic control, and local wound care Also, each wound is treated three times a week for two minutes during 2 weeks (6 sessions) with a placebo, which is the probe of the inactive plasma device along with the pre-recorded sound of the device. Wound area. Timepoint: The measurement is done on the first day of the visit and after every intervention and two days after the last intervention (days 1, 3, 5, 7, 9, 11 and 13). Method of measurement: Take digital photo with ruler - Calculate area with imagej software. Wound grade. Timepoint: The initial grade of the wound at the beginning of the study was first determined by the Wagner criterion and at the end of the study it was also determined based on this criterion. Method of measurement: According to Wagner's criterion. Side effects of cold plasma radiation on the patient. Timepoint: During and after radiation of the plasma. Method of measurement: Ask the patient about possible symptoms and see the wound's position. Rasht University of Medical Sciences Approved 2023-08-09 Ethics committee of Guilan University of Medical Science Office for Research and Technology, Shahid Siadati St, Namjoo St, Rasht Rasht Guilan Iran (Islamic Republic of)