Determining the effect of dry needling on the healing of diabetic ulcer using ulcer area and blood flow indicators.
Design
Patients will be included in the research through the available sampling method and will be divided into three groups using the permuted block randomization method using online randomization (www.sealedenvelope.com)
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 30 patients
Settings and conduct
Subjects with diabetic foot ulcers will be selected from among those who refer to the diabetes clinic center affiliated with diabetes research institutes of Tehran University of Medical Sciences.The patients will be included in the research through the available sampling method and will be divided into three groups. Participants and experts who measure the variables.They are not aware of whether they are in the placebo or intervention group.
Participants/Inclusion and exclusion criteria
Patients over 40 years of age with at least one diabetic neuroischemic ulcer resistant to treatment are included in the study.
And if people have an infection in the ulcer area and do not consent to participate in the study, they will not be included
Intervention groups
Diabetic patients will be included in the research through the available sampling method and will be divided into three groups with the same sample size in the standard treatment group (blood sugar control, Infection control, proper debridement, new wound dressing) or one of the intervention groups (standard treatment with dry needling or standard treatment with placebo needling) are divided.
Main outcome variables
Ulcer area؛ ulcer depth؛ pain intensity؛ neuropathy intensity؛ viberation perception؛ quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230724058903N1
Registration date:2023-10-15, 1402/07/23
Registration timing:registered_while_recruiting
Last update:2023-10-15, 1402/07/23
Update count:0
Registration date
2023-10-15, 1402/07/23
Registrant information
Name
Fatemeh Hasannia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2620 9839
Email address
fhasannia@tums.razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-07-31, 1403/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the effects of dry needling on healing outcomes of foot ulcers from diabetes: A randomized clinical trial
Public title
Study on the effects of dry needling on healing outcomes of foot ulcers from diabetes: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
40 years old and above
Having at least one diabetic ulcer of the neuroischemic type that is resistant to treatment (after 1 month of standard treatment, it has not yet disappeared) in the area of the feet and fingers.
Grade 2 wound on the Wagner scale
• 16 cm2 ≥ ulcer size ≥1 cm2
Hba1c< %12
Exclusion criteria:
Foot ulcer with osteomyelitis or bone infection
Ulcers that have healed up to 50% within 4 weeks
Subjects with immune system deficiency, severe infection in the wound area
Having a history of radiotherapy in the last 120 days
A history of leg venous thrombosis in the last 6 months
History of lymphedema, thrombocytopenia and cellulitis
A history of needle phobia
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is on the web (www.sealedenvelope.com) and is of block type. This feature helps the researcher to ensure that the number of samples allocated to each of the study groups is equal in cases where intermediate analyzes are needed during the sampling process. A three-group clinical trial of 3 blocks including 10 participants in the intervention group (common treatment with dry needling), 10 participants in the placebo group (common treatment with placebo needling) and 10 participants in the common treatment group (control blood sugar, infection control, proper debridement, new wound dressing).
Blinding (investigator's opinion)
Double blinded
Blinding description
Qualified patients for the study, physiotherapists and wound experts who take the specific tests from the patients at the beginning of the treatment, in the middle and at the end of the treatment do not know whether the patients are placed in the placebo or dry needling group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Endocrine and Metabolism Research Institute - Tehran University of Medical Scien
Street address
No. 54 , Tandis street, Nelson Mondela street, Tehran
City
Tehran
Province
Tehran
Postal code
1915643584
Approval date
2023-10-08, 1402/07/16
Ethics committee reference number
IR.TUMS.EMRI.REC.1402.074
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Ulcer area in Image j software
Timepoint
Before the study, one month and three months after the beginning of the study
Method of measurement
Image j software
2
Description
Measuring the depth of the ulcer using a calibrated probe
Timepoint
Before the study, one month and three months after the beginning of the study
Method of measurement
calibrated probe
3
Description
Measuring blood flow using ABI and TBI tests
Timepoint
Before the study, one month and three months after the beginning of the study
Method of measurement
ABI and TBI tests
Secondary outcomes
1
Description
Pain intensity score
Timepoint
Before the study, after first session, one month and three months after the beginning of the study
Method of measurement
Numerical rating scale
2
Description
Neuropathy severity score
Timepoint
Before the study, one month and three months after the beginning of the study
Method of measurement
Michigan and diabetic neuropathy questionnaires
3
Description
Vibration sensation score
Timepoint
Before the study, one month and three months after the beginning of the study
Method of measurement
The Neurothesiometer
4
Description
Quality of life score
Timepoint
Before the study, one month and three months after the beginning of the study
Method of measurement
Wound- QOL questionnaire
Intervention groups
1
Description
Intervention group 1: Standard treatment and Dry needling
Category
Treatment - Devices
2
Description
Intervention group 2: Standard treatment and Sham needling
Diabetes clinic center affiliated with diabetes research institutes of Tehran University of Medical
Full name of responsible person
Soofia Naghdi Dorabati
Street address
No. 54 , Tandis street, Nelson Mondela street, Tehran
City
Tehran
Province
Tehran
Postal code
1915643584
Phone
+98 21 2620 9839
Email
Fhasannia91@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soofia Naghdi Dorabati
Street address
No. 54 , Tandis street, Nelson Mondela street, Tehran
City
Tehran
Province
Tehran
Postal code
1915643550
Phone
+98 21 2620 9839
Email
fhasannia91@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Soofia Naghdi Dorabati
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Pich Shamiran, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
naghdi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soofia Naghdi Dorabati
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Pich Shamiran, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
naghdi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soofia Naghdi Dorabati
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Pich Shamiran, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
naghdi@sina.tums.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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
The complete study protocol will be presented in the form of an article.
Comprehensive statistical analysis will be done and presented after the completion of data collection.
The informed consent form will be provided to the patients.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
It will be available for researchers working in academic and scientific institutions.
From where data/document is obtainable
Email: naghdi@sina.tums.ac.ir
What processes are involved for a request to access data/document
After the request of researchers working in academic and scientific institutions in the form of e-mail, information will be provided to them as soon as possible.