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Investigating the effect of cold atmospheric argon plasma versus standard placebo treatment on wound healing in patients with diabetic foot ulcers

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240708062359N1
Enrollment
78
Registered
2024-08-16
Start date
2024-09-22
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Diabetic foot ulcer. Type 1and2 diabetes mellitus

Interventions

Intervention 1: Intervention group: Atmospheric cold plasma provided by single atmospheric pressure cold plasma jet will be used. The gas used in this jet is argon and its purity can be around grade t

Sponsors

Yazd University of Medical Sciences
Lead Sponsor
Yazd University
Collaborator
Shahid Beheshti University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Absence of addiction and smoking Getting Cancer Taking immunosuppressive drugs Pregnant patients

Design outcomes

Primary

MeasureTime frame
Greater reduction of bacterial load in the intervention group. Timepoint: At the beginning and the second week and the last week before and after the treatment. Method of measurement: microbial culture.;Greater reduction in the level of diabetic ulcer in the intervention group. Timepoint: Before treatment and every treatment session. Method of measurement: Photographs will be taken in each treatment session using a digital camera with a fixed distance marked with a ruler and a ruler next to the wound, then the images will be analyzed with ImageJ software.;Further reduction of the depth of diabetic ulcer in the intervention group. Timepoint: Before treatment and every treatment session. Method of measurement: Silhouette device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahboubeh Ayatollahi

Yazd university

m.ayatollahi@stu.yazd.ac.ir+98 35 3525 1205

Outcome results

None listed

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