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Studying the effect of foot position on tissue oxygenation in diabetic foot ulcers

Protocol summary

Study aim
Determining the effect of foot position on tissue oxygenation (TCPO2) in diabetic foot ulcers
Design
A randomized controlled clinical trial, conducted on 60 patients with diabetic foot ulcers, will be conducted using Python using the Permutation and Random library.
Settings and conduct
This study was conducted in the surgical department of 4 Velayat Hospital affiliated with Mashhad University of Medical Sciences and demographic information, transcutaneous oxygen tension values, limb pressure, and ankle and calf circumferences were measured. Then, in the intervention group, the patient's leg will be elevated 15 degrees from the bed surface by measuring with a goniometer and placed on a pillow for 24 hours. In the control group, the leg with the ulcer will be placed on the bed surface in a supine position for 24 hours. In both groups, the calf and ankle circumferences were measured twice before and during the intervention, and transcutaneous oxygen tension values ​​were measured and recorded by the nurse caring for the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with diabetic foot ulcers (arterial ulcers) with grades 2C, 2D, 3C and 3D based on the Texas criteria and without any therapeutic intervention and care in the inpatient ward - No history of disease such as epilepsy, cognitive disorders, orthopedic, cardiovascular problems, infection, amputation - No contraindications to foot positioning Exclusion criteria: Failure to comply with the treatment protocol including foot positioning for more than two hours
Intervention groups
Intervention group (foot elevation): The ulcerated foot in patients in this group will be placed at a height of 15 degrees above the heart level for 24 hours. Control group (foot supine): The ulcerated foot will be placed on the bed surface for 24 hours.
Main outcome variables
Transcutaneous oxygen pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241223064142N1
Registration date: 2025-01-03, 1403/10/14
Registration timing: prospective

Last update: 2025-01-03, 1403/10/14
Update count: 0
Registration date
2025-01-03, 1403/10/14
Registrant information
Name
Fatemeh Khani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3760 5532
Email address
fatemehkhani4401@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-04-22, 1404/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of foot position on tissue oxygenation in diabetic foot ulcers
Public title
The effect of foot position on tissue oxygenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic foot ulcers with grades 2C, 2D, 3C, and 3D based on the Texas criteria Has an arterial ulcer (neuroischemic) without any therapeutic intervention or care in the inpatient ward No medical contraindication to participate in the study No restrictions on foot positioning Absence of diseases such as epilepsy and cognitive disorders, orthopedic, cardiovascular problems, infection, amputation
Exclusion criteria:
Changing the patient's position to a position that is not in line with the study objectives. If the patient is not in the study position for more than two hours.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment will be done with Python version 3 using the permutations and random libraries. These two libraries will be used to generate random sequences using the block generation method (here, blocks of 4 and 2 are used, which will be randomly generated and will randomly generate the sequence).
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
Faculty of Nursing and Midwifery -Mashhad University of Medical Sciences
Street address
Mashhad, Azadi Square, Mashhad University of Medical Sciences, Faculty of Medicine, First Floor
City
mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2024-12-28, 1403/10/08
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.077

Health conditions studied

1

Description of health condition studied
Ulcer of lower limb, not elsewhere classified
ICD-10 code
L97
ICD-10 code description
Non-pressure chronic ulcer of lower limb, not elsewhere classified

Primary outcomes

1

Description
Transcutaneous oxygen pressure
Timepoint
Transcutaneous oxygen pressure measurement before the start of the intervention and 24 hours after the start of the intervention
Method of measurement
In the present study, transcutaneous oxygen pressure measurement was used via a touch screen monitor and a single-channel probe manufactured by Medicap, Germany.

2

Description
Calf circumference
Timepoint
Calf circumference measurement before the start of the intervention and twice during the 24-hour intervention
Method of measurement
Measuring calf circumference with a standard tape measure

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The ulcerated leg in patients in this group will be placed on a pillow at an elevation of 15 degrees above the heart level for 24 hours.
Category
Treatment - Other

2

Description
Control group: The ulcerated leg in patients in this group will be placed on the bed surface for 24 hours.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Gholamhossein Kazemzadeh
Street address
Intersection of Namaz Boulevard and Shahid Kaveh Boulevard, Velayat Hospital, Mashhad City
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩۰۰۰١
Phone
+98 51 3804 2000
Email
khazemzadegh@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Street, next to Hoveyzeh Cinema, University of Medical Sciences, Third Floor, Vice Chancellor for Research and Technology of the University,Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Khani
Position
Master's degree student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Intersection of Namaz Boulevard and Shahid Kaveh Boulevard, Velayat Hospital, Mashhad City
City
mashhad
Province
Razavi Khorasan
Postal code
917789001
Phone
+98 51 3804 2000
Email
khaniF4012@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Arian Yeganeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Intersection of Namaz Boulevard and Shahid Kaveh Boulevard, Velayat Hospital, Mashhad City
City
mashhad
Province
Razavi Khorasan
Postal code
917789001
Phone
+98 51 3804 2000
Email
Ariyanm@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Khani
Position
Master's degree student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Intersection of Namaz Boulevard and Shahid Kaveh Boulevard, Velayat Hospital, Mashhad City
City
mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 51 3804 2000
Email
khaniF4012@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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