Protocol summary

Study aim
Determination of the Effect of Plasma Radiation on the Treatment of Diabetic Foot Infections and decrease of bacterial load and ulcer size
Design
This is a double-blind clinical trial. Diabetic patients referred to diabetic clinics with 40 cases of diabetic foot ulcer infection are selected based on entry and exit criteria. After completing the informed consent form and the questionnaire, diagnostic tests are performed for all patients. Blood samples are taken from all patients for the following tests: FBS, HbA1c, Cr. , BUN, CBC, CRP, Chol, TG, LDL, HDL, ALT, AST, ALK Ph The standard measures are taken to treat the wounds of diabetic patients: 1) Normal saline wash and wound debridement 2) Appropriate antibiotic administration 3) Reduced wound pressure 4) Suitable dressing 5) Patient training 6) Patient's glycemic control. Sampling of wound secretions is performed to perform cytokine tests or angiogenesis factors before and during the third week. Then, in both groups, the wound of the scar tissue is wound in the standard method at regular intervals of the week.  A cold jet plasma rifle will be used as the source for the jet plasma with helium gas. The plasma is created in 1 day intervals and each time for 5 minutes on the wound will be directly exposed.
Settings and conduct
Diabetes Clinic - Diabetes Research Center
Participants/Inclusion and exclusion criteria
The criteria for entering the design are: 1) Grade 2 wounds according to Wagner and Texas classification and stage B 2; and 3) Wound type: Neuropathy, neuroiscaemia Exit criteria: 1) Pregnancy 2) Lactation 3) Cancer diagnosed and treated 4) Under 18 years of age 5) Dementia 6) Immunosuppressive drugs 7) Gangrene wounds 8) Ischemic ulcer 9) Non-cooperation
Intervention groups
Diabetic Patients with infected foot ulcers
Main outcome variables
Reduce bacterial load and the size of the wound and Formation of granulation tissue

General information

Reason for update
Acronym
پلاسمای سرد و زخم پای دیابتی
IRCT registration information
IRCT registration number: IRCT20080904001199N2
Registration date: 2018-04-07, 1397/01/18
Registration timing: retrospective

Last update: 2018-04-07, 1397/01/18
Update count: 0
Registration date
2018-04-07, 1397/01/18
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
2017-04-04, 1396/01/15
Expected recruitment end date
2017-10-07, 1396/07/15
Actual recruitment start date
2017-04-04, 1396/01/15
Actual recruitment end date
2017-10-07, 1396/07/15
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of cold plasma radiation in the treatment of infected wounds diabetic foot and molecular mechanisms related
Public title
Effect of cold plasma on diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patient with infected ulcer DFU grade 2 Neuropathic and Neuroischemin Ulcer ABI>0.8 , ABI<1.3
Exclusion criteria:
Not patient compliance Ischemic ulcers Pregnancy cancer Dementia age< 18 Immunosuppressive therapy Gangrene Ulcer
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The first step in the random process is to create a random sequence. The second step after creating a random sequence is to hide the generated sequence. To use the random number table, we must first determine the number of the table to read. The second is to consider numbers for different groups (for example, pair numbers for intervention A and individual numbers for intervention B, then hand over one of the numbers and move in one of the directions predetermined and record the numbers We assign to different groups. Blocking is usually used to create a balance in the number of specimens assigned to each of the groups studied, for example, in blocks of 4 that have two allocations to the intervention group and two allocations to the control group Is taken.
Blinding (investigator's opinion)
Double blinded
Blinding description
Doctors and nurses, as well as the patient, are unaware of the grouping, and the only expert on plasma radiation is aware of this. Patients do not see the ulcer during plasma radiation
Placebo
Used
Assignment
Single
Other design features
NO

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Endocrinology and Metabolism Research Institute
Street address
Dr. Shariati Hospital , 5th floor
City
Tehran
Province
Tehran
Postal code
1411413137
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.TUMS.EMRI.REC.1395.0089

Health conditions studied

1

Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications

Primary outcomes

1

Description
Area of ulcer
Timepoint
After selecting a patient for up to 3 weeks in each visit (one day in between), the size of the patient's wound is measured.
Method of measurement
take a photo with ruler and analysis it

2

Description
microbial colony count
Timepoint
Up to 3 weeks after the patient's choice, once a week, a microbial culture of the wound secretions is performed
Method of measurement
with standard method swap

3

Description
cytokines and growth factors
Timepoint
at the first and end of third week
Method of measurement
128/5000Samples from ulcerous secretions are taken with pasteurized sterile pipettes and then by ELISA, cytokines and growth factors are measured.

Secondary outcomes

1

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
In this study, a cold jet plasma rifle machine will be used as a source of helium gas jet plasma. The plasma is created in 1 day intervals 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
Diabetes Clinic - DRC
Full name of responsible person
Dr. Nasli
Street address
North Kargar st., Shahrivar St.
City
Tehran
Province
Tehran
Postal code
2222233333
Phone
+98 21 8822 0037
Email
n.nasli@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Dr. Neda Mehrdad
Street address
near the Dr. shariati Hospital
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
Endocrinology and Metabolism Research Institute
Proportion provided by this source
70
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
Plasma physics research Center
Full name of responsible person
Dr. ghorannevis
Street address
Azad university , central organization, research science Unit
City
Tehran
Province
Tehran
Postal code
11111222222
Phone
+98 21 8822 0037
Email
amini80@YAHOO.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Plasma physics research Center
Proportion provided by this source
30
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
Endocrinology and Metabolism Research Institute
Full name of responsible person
Mohammad Reza Amini
Position
GP and DF PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Dr. Shariati Hospital 5th floor
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Fax
+98 21 8822 0052
Email
mramini@tums.ac.ir
Web page address
http://emri.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Endocrine Research Center
Full name of responsible person
Mohammad Reza Mohajeri Tehrani
Position
Prof. of Endocrinology
Latest degree
Subspecialist
Other areas of specialty/work
Endocrine
Street address
Dr. shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Fax
+98 21 8822 0052
Email
mrmohajeri@tums.ac.ir
Web page address
http://emri.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Mohammad Reza Amini
Position
GP and PhD DF student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Dr. shariati hospital, 5th floor
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Fax
+98 21 8822 0052
Email
mramini@tums.ac.ir
Web page address
hhttp://emri.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
ethical
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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