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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20181012041317N1

Enrollment

Registered

2018-11-05

Start date

2018-11-26

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer. Type 2 diabetes mellitus with peripheral circulatory complications

Interventions

Intervention 1: Intervention group: In this study , plasma torch will be used as the source of helium gas jet plasma. The plasma is created in 2 days a week, and each time for 5 minutes on the wound

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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%

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShirin samsavar

Shahid beheshti university

shirinsamsavar@gmail.com+98 21 2990 4017

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026