Investigating the effect of cold atmospheric argon plasma compared to standard placebo treatment in improving the surface and depth and reducing the wound bacterial load and duration in patients with diabetic foot ulcers

Investigating the use of cold atmospheric plasma on wound healing in patients with diabetic foot ulcers; on reducing the bacterial load of diabetic foot ulcers; on reducing the level of diabetic foot ulcer; on reducing the depth of diabetic foot ulcer; on reducing the duration of diabetic foot ulcer treatment

A clinical trial with a control group, with a double-blind, randomized group, on 39 patients in each control group and testing in three grades of diabetic ulcers based on Wegener criteria. Randomization is done by simple random method. First, using the PASS 2021 software, we generate a random sequence using a simple random allocation method. The output of the software in the form of an Excel file contains a sequence of numbers from 1 to 78 and a unique code for research units.

In this study, the effect of cold argon plasma as a treatment along with the standard treatment on the healing of diabetic foot ulcers grade 1 to 3 in the diabetes research center of Yazd province is investigated and compared with the standard treatment group with placebo in a double-blind method. If the patients agree, a written consent form will be obtained from them. After obtaining written consent, recording basic data related to each patient, clinical examination (questionnaire), patients are debrided. And intervention and placebo is done

The patient has a diabetic foot ulcer based on the Wegener classification from grade 1 to 3. The age limit of patients is 18 to 90 years Patient satisfaction

The intervention of cold atmospheric argon plasma along with standard treatment in grades 1 to 3 diabetic wounds based on Wegener criteria

Reduction of bacterial load; surface; The depth of the wound and the reduction of the duration of complete healing of the wound

Considering that the level of the wound is the main response variable, considering the significant level of 5% and the power of the test at 80%, and considering the standard deviation value of the reduction of the level of wound from the previous study (Startmann, et al, 2020.) S= 11.8 was obtained and in order to achieve a clinically significant difference in the reduction of wound level in the intervention group compared to the control group at the end of the study, at least 8 units, the number of 35 people in each group, and including 10% shedding, the number of 39 people in each case group it is needed. Randomization is done by simple random method. First, using the PASS 2021 software, we generate a random sequence using a simple random allocation method. The output of the software in the form of an Excel file contains a sequence of numbers from 1 to 78 and a unique code for the research units. For the eligible sample, numbers from one to 78 are considered and will be assigned to an intervention group (A or B). The first eligible sample will be assigned number 1, the second sample will be number 2, and in the same way up to 78 samples will be assigned to the groups.When the eligible sample comes to the study, based on the number of the person in the intervention group, a third person is asked over the phone, and the person's allocation to one of the groups is determined and carried out.

Patients will be randomly grouped by an independent person and will receive the treatment or placebo based on the time and period determined along with the standard treatment. In order to double-blind the study, the grouping is done by a person who is not familiar with the nature of the treatment groups, and the wounds are treated and processed with plasma and photographed by a trained doctor in a room where only the patient and the doctor are present. And the statistical processing of the obtained data and the conclusions are made by another uninformed person. Also, in order for the patient not to know about his treatment group, a curtain is placed between the patient and the place of treatment, and if the patient is in the standard treatment group, the voice Processing with previously recorded plasma is played back.

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ne year after defending the thesis

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Mahboubeh Ayatollahi 00989133550850 m.ayatollahi@stu.yazd.ac.ir

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