The aim of this study was to determine the effect of topical oxygen therapy in diabetic foot ulcer patients in order to increase the quality of nursing care and improve the satisfaction of patients with diabetic foot ulcers in Qazvin University of Medical Sciences affiliated hospitals.
Design
Patients were randomly divided into two intervention and control groups. In the control group, only daily care, including regular care (dressing twice per shift), was performed, such as daily washing with normal saline and then with sterile gas And will be done with common dressing products and in the intervention group, in addition to the above-mentioned care, daily by catheter, 10 liters per minute flow of oxygen for 20 minutes three times a day for at least one week (or clearance time) at a distance of one centimeter wound will be rotated. The condition of the ulcer will be examined by the test cavity before and every 48 hours after the intervention for at least one week and (or until discharge)
Settings and conduct
This study is a randomized controlled trial with a representative sample of 40 patients admitted to the surgical ward of diabetic foot ulcer grade 2 and more in teaching hospitals affiliated to Qazvin University of Medical Sciences(VElayat and Buali Sina)
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patient's or CARE GIVER's consent
Exclusion criteria: Specific vascular injury such as buerger disease
Intervention groups
In the intervention group, the ulcer was first washed three times with sterile normal saline and then topically extruded with a high pressure of 10 liters per minute for 20 minutes. This is done three times a day
Main outcome variables
ULCER AREA-PAIN
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190708044148N1
Registration date:2019-08-26, 1398/06/04
Registration timing:registered_while_recruiting
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Alireza Salmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3283 6289
Email address
alirezasalmani192@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-16, 1398/04/25
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study Of the Effect of Topical Oxygen Therapy on Diabetic Foot Ulcer
Public title
The Effect of Oxygen on Diabetic Foot Ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ankle Brachial Index at Least 0.6
Patient's Personal consent or Companion Patient
Exclusion criteria:
Specific Vascular Injury Such as Buerger Disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this Study, Kevin Tosing method and simple random assigment method (using red and blue balls, the red ball representing the control group and the blue balloon representing the intervention group) will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
Intervention will take place on both day and day and on shifts in the morning and evening. Patients or their families were unaware of the intervention, so this is a one-blind study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
QAZVIN UNIVERSITY MEDICAL OF SCIEMCE
City
QAZVIN
Province
Qazvin
Postal code
3414638588
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.QUMS.REC.1397.395
Health conditions studied
1
Description of health condition studied
DIABETIC FOOT ULCER
ICD-10 code
E13
ICD-10 code description
Other specified diabetes mellitus
Primary outcomes
1
Description
FOOT ULCER AREA
Timepoint
Before and every 48 hours after the intervention for at least one week and (or until discharge
Method of measurement
The measurements are sterilized with Absalung
2
Description
PAIN OF DIABETIC FOOT ULCER
Timepoint
Before AND POST INTERVENTION
Method of measurement
VISUAL ANALOG SCALE
3
Description
Stress
Timepoint
Before intervention
Method of measurement
cohen perceived stress scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the ulcer was washed three times with sterile normal saline, and then a high pressure oxygenated portion of 10 liters per minute was placed on the document for 20 minutes. At last, the wound was dressed with enough gas. This case is repeated three times a day.Document for 20 minute: Based on the study by Eric Blackman et al. (2010), a study of treatment of severe diabetic foot ulcers with topical oxygen: a prospective controlled study at the Ontario Wound Center Clinic in Canada on 28 diabetic patients who had two The intervention and control groups were divided into two groups of silver bandages at least twice a week and in the intervention group 60 minutes of oxygen daily with topical wound treatment oxygen therapy (TWO2) given for 90 days from Monday to Friday. Were treated. Therefore, treatment was performed in 60 minutes and in three alternating 20 minute periods.
Category
Treatment - Other
2
Description
Control group: At first, the wound was closed three times with a normal saline serum, then with a sterile dry gel and then, depending on the size of the wound, with one or more dry sterilized gases.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bou Ali Sina Hospital
Full name of responsible person
DOCTOR MOHAMMAD ALI ZOHAL
Street address
Bu-Ali Sina Hospital, Qazvin- Bou-Ali Avenue,QAZVIN
City
QAZVIN
Province
Qazvin
Postal code
3414638588
Phone
+98 28 3333 6000
Email
NARGESHOSSINI123@GMAIL.COM
2
Recruitment center
Name of recruitment center
VELAYAT HOSPITAL
Full name of responsible person
DOCTOR ALI AKBAR KARAMI
Street address
VELAYAT HOSPITAL -MINODAR -QAZVIN
City
QAZVIN
Province
Qazvin
Postal code
3414638588
Phone
+98 28 3333 6000
Email
NARGESHOSSINI123@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
ZAHRA KALANTARI
Street address
RESEARCH Assistance QAZVIN
City
QAZVIN
Province
Qazvin
Postal code
341999-15315
Phone
+98 28 3333 6000
Email
NARGESHOSSINI123@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
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
Qazvin University of Medical Sciences
Full name of responsible person
DOCTOR JALIL AZIMIAN
Position
PHD OF NURSING
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
FACTULY OF NURSING- QAZVIN MEDICAL OF SCIENCE
City
QAZVIN
Province
Qazvin
Postal code
34146388588
Phone
+98 28 1223 7267
Email
jazzimian@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
DOCTOR JALIL AZIMIAN
Position
PHD OF NURSING
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
FACTULY IF NURSING- QAZVIN MEDICAL OF NURSING
City
QAZVIN
Province
Qazvin
Postal code
3414638588
Phone
+98 28 1223 7267
Email
jazzimian@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
DOCTOR JALIL AZIMIAN
Position
PHD OF NURSING
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
FACTULY IF NURSING - QAZVIN MEDICAL OF SCIENCE
City
QAZVIN
Province
Qazvin
Postal code
3414638588
Phone
+98 28 1223 7267
Email
Jazzimian@qums.ac.ir
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
EMPTY
When the data will become available and for how long
EMPTY
To whom data/document is available
EMPTY
Under which criteria data/document could be used
EMPTY
From where data/document is obtainable
EMPTY
What processes are involved for a request to access data/document