The Study of the Effectiveness of Atmospheric Pressure Plasma in the Improvement of Diabetic Wounds
Design
Clinical trial with a double-blind, randomized, controlled group, based on patients with diabetic foot ulcers with a parallel group
Settings and conduct
Razi Hospital affiliated to Tehran University of Medical Sciences will be considered as a research environment. At first, qualified people will enter the study after consent is obtained consciously. Using random allocation method, they are divided into two groups. The intervention group is exposed to atmospheric pressure plasma for 6 weeks. The control group is under common treatment. This is a double-blind study.Clinical participants and caregivers have been blinded and The only expert on plasma radiation is aware of this .
Participants/Inclusion and exclusion 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 : 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%
Intervention groups
The intervention group includes diabetic patients with foot ulcers,exposed to atmospheric pressure plasma . The control group includes diabetic patients with foot ulcers that are under common treatment.
Main outcome variables
Wound area; Exudate levels ; Type of wound tissue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181012041317N1
Registration date:2018-11-05, 1397/08/14
Registration timing:prospective
Last update:2018-11-05, 1397/08/14
Update count:0
Registration date
2018-11-05, 1397/08/14
Registrant information
Name
Shirin Samsavar
Name of organization / entity
Shahid beheshti university
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 4017
Email address
shirinsamsavar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-26, 1397/09/05
Expected recruitment end date
2018-12-26, 1397/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of atmospheric pressure plasma and common treatment in diabetic patients with foot ulcer
Public title
The effect of atmospheric pressure cold plasma in patients with diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion 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:
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%
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
The doctor and the patient are unaware of the grouping, and only the plasma radiation expert knows.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice-chancellor for Research of Tehran University of Medical Sciences, 205th room, 1st floor, Education Bldg, Poursina st.
City
Tehran
Province
Tehran
Postal code
1416634391
Approval date
2018-05-23, 1397/03/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.010
Health conditions studied
1
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E11.5
ICD-10 code description
Type 2 diabetes mellitus with peripheral circulatory complications
Primary outcomes
1
Description
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
2
Description
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
3
Description
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 outcomes
1
Description
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
2
Description
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
Intervention groups
1
Description
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 will be directly exposed.
Category
Treatment - Other
2
Description
Control group: In this group only standard wound care treatments such as debridement, dressing, antibiotic administration, and patient education, and no plasma radiation, will be used.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Hamid-Reza Mahmoudi
Street address
Razi Skin Hospital, Razi Ave., Vahdate eslami Ave., Hafiz St.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0174
Email
hr_mahmoody@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid beheshti university
Full name of responsible person
Dr . Babak shokri
Street address
Shahid Beheshti University - Velenjak st , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2788
Email
babakshokri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti university
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid beheshti university
Full name of responsible person
Shirin samsavar
Position
student
Latest degree
Master
Other areas of specialty/work
plasma physics
Street address
Daneshjou Blvd , District , Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 4017
Email
shirinsamsavar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
DR . Hamid-reza mahmoudi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Skin hospital, Razi Ave., Vahdate eslami Ave., Hafez St.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Email
hr_mahmoody@yahoo.com
Web page address
htpps://razihos.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid beheshti university
Full name of responsible person
shirin samsavar
Position
student
Latest degree
Master
Other areas of specialty/work
Plasma physics
Street address
Daneshjou Blvd , District , Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 4017
Email
shirinsamsavar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data collected for the primary and secondary outcome measurements .
When the data will become available and for how long
startting 9 month after publication until 5 years later
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of data and documentation is not allowed in any article, thesis, etc.
From where data/document is obtainable
The applicant for documentation can be contacted by email with person responsible for scientific inquiries and person responsible for general inquiries .
person responsible for scientific inquiries : Dr. Hamid Reza Mahmoudi
hr_mahmoody@yahoo.com
person responsible for general inquiries : shirin samsavar
shirinsamsavar@gmail.com
What processes are involved for a request to access data/document