The effect of ozonatedolive gel on the healing of diabetic foot ulcers

Determining and comparing the quality of life score and wound grade based on the Wagner scale at the end of each week for one month

A controlled, parallel-group, single-blind, randomized clinical trial on 80 patients. Block randomization will be used for randomization

In this study, a randomized clinical trial is the research environment of Shahid Hospital. Blinding is performed on the analyzers.

Inclusion: Patients with leg ulcers of grade 2 or 3 according to the Wagner scale, Persian speaking, patients who receive only standard and common treatment. Eligible patients are randomly included in the study after personal consent. These patients were not included in the study: they receive other treatments - they show sensitivity to the topical formulation - they do not want to continue the treatment. If they need other advanced treatments, they will be excluded from the study.

The patients in the test group receive the usual treatment of diabetic foot ulcers (including topical treatments - local or systemic antibiotics) along with the topical olive oil gel formulated in this study once a day for 4 weeks.

Quality of life and degree of wound

In order to select the sample, after preparing a list of patients with diabetic foot ulcers covered by Bandar Abbas Shahid Mohammadi Hospital, they will be contacted. Then, 80 people who want to participate in the research will be selected using available sampling and will be included in the study based on the criteria for entering the research. And they will be randomly assigned to two groups of olive gel, ozone and control, each of which has 40 participants. In order to randomize the samples, the block randomization method, which is a limited randomization method related to studies with groups with the same sample size, will be used. Also, in this study, according to the sample size, 10 blocks of 8 blocks will be considered. In order to implement this method, the website https://www.sealedenvelpe.com will be used. And on the mentioned site, the titles of the two groups (intervention and control), the number of blocks and the volume of each block will be mentioned, which include 10 blocks of 8. Then, according to the randomization obtained from the site and the last three numbers of the patients' files, randomization will be done. In this way, in front of the obtained randomizations, we will write down the last three numbers of the patients' files in order from the least to the most, and according to that, the patients will be included in each of the control and intervention groups.

This study is a single-blinded clinical trial. Therefore, blinding will be implemented in the evaluators who will analyze the study data. For this purpose, the questionnaires that will be completed by the researchers in all three groups, in the form of a contract between the researchers, with one of the English letters above it, it will be determined which of the study groups the questionnaire was completed by the participants; However, the evaluators of the data analysis will not be aware of the English letter of agreement between the researchers assigned to each group.

Only part of the data, such as information related to the main outcome and general demographic information, can be shared.

The access period starts 3 months after the results are published

Doctors, nurses, , researchers working in universities and medical centers and hospitals

In order to use it for scientific purposes and by mentioning the source used and requesting the journal in which the article will be published

Communication via e-mail (if it is possible to share information from a legal and ethical point of view, such as sharing the primary result of the study) to receive information, contact the following email address: Corresponding author's email: zare2121@gmail.com.

Finding the email of the responsible author, stating the reason, complying with ethical and legal issues; In this case, a quick response will be given to the requester.