The effect of atmospheric pressure cold plasma in patients with diabetic foot ulcer

Not Applicable

• Conditions: Diabetic Foot Ulcer.; Type 2 diabetes mellitus with peripheral circulatory complications

• Registration Number: IRCT20181012041317N1
• Lead Sponsor: Shahid beheshti university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Type 2 diabetes
Has diabetic ulcer size (1-30) cm2
Wound do not have more than 2 years of age.
Hb1Ac < 10%
Do not have bone infection
Patient over 18 years of age

Exclusion Criteria

Patients with addiction or alcohol abuse
Patients with psychological problems or dissatisfaction with the company in the study
Patients with diabetic nephropathy
Localized necrosis /Gangrene
Hb1Ac > 10%

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound area. Timepoint: After selecting the patient during the 12 sessions (weekly 2 sessions) in the first session (before the treatment) and the end of session 6 and 12, the area of the wound is checked. Method of measurement: Take digital photo with ruler - Push score - Calculate area with imagej software.;Exudate levels. Timepoint: At the first session (before treatment) and the end of session 6 and 12 , a microbial culture of the wound secretions is performed. Method of measurement: with standard method swap - Push score.;Type of wound tissue. Timepoint: The first session (before treatment) and the end of session 6 and 12 are checked. Method of measurement: Take digital photo - Push score.

Secondary Outcome Measures

Name	Time	Method
Quality of life. Timepoint: Before treatment - the end of treatment - 8 weeks after the end of treatment. Method of measurement: Diabetes Quality of Life (DQOL) Questionnaire.;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.