Our aim in this study was to investigate the ability of atmospheric pressure plasma to improve the quality, speed of healing and healing of diabetic wounds in the human phase using argon jet, which is also more economical than helium jet.
Design
The clinical trial has two groups of control and intervention with parallel, non-blind, randomized groups and also in the third phase of the clinical trial study. Block Randomization table method was used for randomization.
Settings and conduct
Endocrinology and metabolism research institute of Tehran university of medical science.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1- The patient has G2 or G3 diabetic foot ulcer according to Wagner classification.
2- The patient has an infectious diabetic foot ulcer. (Symptoms such as redness, pain, discharge, and tenderness)
3- There is no age or sex limit in this study.
Exclusion Criteria:
1- Getting cancer
2- Taking immunosuppressive drugs
3- Pregnant patients
4- Patients with a bone infection (Osteomyelitis)
5- The patient's unwillingness
Intervention groups
Patients participating in this study were randomly divided into two groups using the Block Randomization table method.
Patients in the control group receive standard treatment including washing, debridement, dressing, appropriate antibiotics, and offloading.
In the intervention group, in addition to standard treatment, plasma irradiation is used for 2 minutes per session for 4 consecutive weeks.
Main outcome variables
Rate (percentage) of wound size reduction and wound healing time (granulation tissue formation and epithelialization)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080904001199N5
Registration date:2020-10-15, 1399/07/24
Registration timing:prospective
Last update:2020-10-15, 1399/07/24
Update count:0
Registration date
2020-10-15, 1399/07/24
Registrant information
Name
Mohammad Reza Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0038
Email address
mramini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Use of cold atmospheric argon plasma to heal and accelerate the healing of wounds of infectious diabetic foot
Public title
The effect of argon plasma in the treatment of diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
G2 or G3 grade diabetic foot ulcer according to Wagner classification
Symptoms of the infection in the wound (erythema, pain, discharge, and tenderness)
Exclusion criteria:
Getting cancer
Taking immunosuppressive drugs
Pregnant patients
Patients with bone infection
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be randomly divided into two groups of control with standard treatment and intervention group with standard treatment plus plasma radiation based on the Blocked randomization table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Endocrinology and metabolism research institute of Tehran university of medical science.
Street address
Shariati Hospital, Floor 5, N Kargar
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2020-09-28, 1399/07/07
Ethics committee reference number
IR.TUMS.EMRI.REC.1399.037
Health conditions studied
1
Description of health condition studied
Infectious diabetic foot ulcers
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications
Primary outcomes
1
Description
Wound area
Timepoint
The wounds of all participants will be photographed in each session.
Method of measurement
Using a digital camera with a ruler and photo analysis in the software environment, the wound area is examined.
Secondary outcomes
1
Description
Reducing bacterial load
Timepoint
Samples of wound secretions are taken at the beginning of the study, mid-treatment and at the end of the study for microbial culture.
Method of measurement
The sample is taken from the depth of the wound using a standard method and the use of a swab.
2
Description
Reduction of wound area
Timepoint
At each visit, the wound area is measured.
Method of measurement
Wound dimensions are measured using a ruler and wound photos are analyzed using software.
Intervention groups
1
Description
Intervention group: In this group, according to the random selection of patients with diabetic foot ulcers after explaining how to treat after observing the principles of treatment (washing and cleaning the wound, wound debridement, if necessary, offloading and finally appropriate dressing) with argon plasma Wipe the wound surface for 2 minutes. The treatment intervals are one week and finally the patient leaves the plan within 1 month of follow-up.
Category
Treatment - Devices
2
Description
Control group: In this group, after accurate wound evaluation, standard treatments including wound washing, wound debridement, use of appropriate antibiotics, offloading (if necessary) and use of appropriate wound dressing are considered.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic - Diabetes Research Center
Full name of responsible person
Dr. E. Nasli
Street address
Endocrinology and metabolism research institute of Tehran university of medical sciences, End of Jalal Al-Ahmad highway
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Email
n.nasli@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Neda Mehrdad
Street address
Endocrinology and metabolism research institute of Tehran university of medical sciences, End of Jalal Al-Ahmad highway
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0088
Email
neda1340@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Laser and Plasma Research Institute of Shahid Beheshti university