Comparison of the efficacy of cold atmospheric plasma and common treatment in diabetic patients with foot ulcer

The Study of the effectiveness of cold atmospheric plasma in healing diabetic foot ulcers

Clinical trial with control group, with parallel groups, single blind, randomized, on 52 patients. Random Allocation software was used for randomization.

The environment of this research is the Razi educational and therapeutic center of Rasht. First, the eligible people will enter the study based on the entry criteria, after obtaining informed consent, and will be divided into two groups using the random allocation method. The people in the intervention group will be exposed to cold atmospheric plasma radiation for 2 weeks (6 sessions). And the people in the control group are subjected to common diabetic foot ulcer treatments along with placebo. This study is single-blind. Participants in this study are blinded.

Inclusion criteria include: age range from 18 to 80 years, having type 1 or 2 diabetes, having a grade 1 or 2 wound in the lower limb based on the Wagner scale. The exclusion criteria include: having a hemoglobin A1C higher than 10%, , pregnant and lactating women, a history of cancer, having artificial pacemakers, having a history of epilepsy.

The intervention group includes patients with diabetic foot ulcers, in which each ulcer is treated with cold plasma three times a week and each time for two minutes during 2 weeks (6 sessions). The control group in this study includes patients with diabetic foot ulcers, in which each ulcer is treated three times a week and for two minutes each time during 2 weeks (6 sessions) with placebo, which is an inactive plasma device probe.

Wound area, wound degree, side effects caused by plasma radiation

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.

Patients in this study are blinded and are not aware of receiving placebo or plasma treatment for the purpose of blinding.

Data collected for the primary and secondary outcome measurements .

startting 12 month after publication until 5 years later

researchers working in academic and scientific institutions

Use of data and documentation is not allowed in any article, thesis, etc.

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

By sending an email, it can receive data.