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Comparison between cryotherapy along laser therapy effects and specific laser therapy effects alone on diabetic foot ulcers, a randomized clinical trial

Protocol summary

Study aim
for Comparison of cryotherapy along laser therapy effects and specific laser therapy effects alone on diabetic foot ulcers
Design
In this study, 30 patients with diabetic foot ulcers, grade 2 and 3 will be randomly divided into three groups by randomization blocks (10 patients in each group).
Settings and conduct
The study will be conducted in the diabetes clinic and physiotherapy department of the Semnan Kowsar Hospital (Iran).
Participants/Inclusion and exclusion criteria
Participating are diabetic patients with diabetic foot ulcers. Inclusion criteria: Past history of diabetes more than 5 years, age more than 50 years, having at least one noninfectious, non-ischemic and non-hemorrhagic diabetic foot ulcer. Exclusion criteria: Creatinine level higher than 2, ischemia, infection (fever, leukocytosis, elevated ESR level), receiving of corticosteroid or immunosuppressive drug, ulceration due to any causes other than diabetes mellitus, large vessels involvement, chemotherapy, underlying disease, sensitivity to cryotherapy .
Intervention groups
Group A (Cryotherapy and Laser Therapy): Patients in this group, receive cold therapy with ice pack for 30 minutes per session, and laser therapy (low power with an intensity of 3 J/cm2, 6 sessions per week for 4 weeks in addition to routine. Second group (laser therapy): Patients in this group, receive laser therapy (low power with an intensity of 3 J/cm2, 6 sessions per week for 4 weeks in addition to routine treatments. Third Group (control): Patients in this group will receive only routine therapies.
Main outcome variables
Reduction in diabetic foot ulcer size

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151020024625N7
Registration date: 2018-04-23, 1397/02/03
Registration timing: registered_while_recruiting

Last update: 2018-04-23, 1397/02/03
Update count: 0
Registration date
2018-04-23, 1397/02/03
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between cryotherapy along laser therapy effects and specific laser therapy effects alone on diabetic foot ulcers, a randomized clinical trial
Public title
Efficacy of cryotherapy along laser therapy and laser therapy alone on diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Past history of diabetes more than 5 years age more than 50 years having at least one noninfectious, non-ischemic and non-hemorrhagic diabetic foot ulcer.
Exclusion criteria:
Creatinine level higher than 2 Ischemia Infection (fever, leukocytosis, elevated ESR level) Receiving of corticosteroid or immunosuppressive drug, Ulceration due to any causes other than diabetes mellitus Large vessels involvement Chemotherapy Underlying disease Sensitivity to cryotherapy
Age
From 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into three groups by randomization blocks
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
Ethical Committee, Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2018-02-06, 1396/11/17
Ethics committee reference number
IR.SEMUMS.REC.1396.232

Health conditions studied

1

Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E13.51
ICD-10 code description
Other specified diabetes mellitus with diabetic peripheral angiopathy without gangrene

Primary outcomes

1

Description
Reduction in diabetic foot ulcer size
Timepoint
30 days after intervention
Method of measurement
Physical Examonation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: Patients in this group, receive cold therapy with ice pack for 30 minutes per session, and laser therapy (low power with an intensity of 3 J/cm2, 6 sessions per week for 4 weeks in addition to routine.
Category
Treatment - Devices

2

Description
Second intervention group (laser therapy): Patients in this group, receive laser therapy (low power with an intensity of 3 J/cm2, 6 sessions per week for 4 weeks in addition to routine treatments.
Category
Treatment - Devices

3

Description
Control group: Patients in this group will receive only routine therapies.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Majid Forootan
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
dr_forotan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asgari
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Email
sem.ums.res@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Majid Forootan
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
dr_forotan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Forootan
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
dr_forotan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research Expert
Latest degree
Bachelor
Other areas of specialty/work
Biostatistics
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2251
Email
mehrdadzahmatkesh@semums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Results of statistical Analysis
When the data will become available and for how long
After completing the project
To whom data/document is available
Only the study researchers and Referee
Under which criteria data/document could be used
For similar studies
From where data/document is obtainable
Dr. Majid Forootan
What processes are involved for a request to access data/document
Calling and Email
Comments
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