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IRCT20230724058903N1 IRCT 2023-10-15 Tehran University of Medical Sciences Study on the effects of dry needling on healing outcomes of foot ulcers from diabetes: A randomized clinical trial Study on the effects of dry needling on healing outcomes of foot ulcers from diabetes: A randomized clinical trial 2023-10-02 anticipated 30 Complete https://irct.ir/trial/71637 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Diabetic foot ulcer. Intervention 1: Intervention group 1: Standard treatment and Dry needling. Intervention 2: Intervention group 2: Standard treatment and Sham needling. Intervention 3: Control group: Standatd treatment (manage blood sugar, infection control, proper debridement, wound dressing). Yes - There is a plan to make this available What will be shared: 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 access period will start 6 months after the results are published. To whom: It will be available for researchers working in academic and scientific institutions. Conditions: It will be available for researchers working in academic and scientific institutions. Where to obtain: Email: naghdi@sina.tums.ac.ir How to obtain: 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. Comments:
public Soofia Naghdi Dorabati
Faculty of Rehabilitation, Pich Shamiran, Enghelab Street, Tehran
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 naghdi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Soofia Naghdi Dorabati
Faculty of Rehabilitation, Pich Shamiran, Enghelab Street, Tehran
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 naghdi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 40 years no limit Both 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 Treatment - Devices Treatment - Devices Treatment - Devices Intervention group 1: Standard treatment and Dry needling Intervention group 2: Standard treatment and Sham needling Control group: Standatd treatment (manage blood sugar, infection control, proper debridement, wound dressing) 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. 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. 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. 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. 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. Vibration sensation score. Timepoint: Before the study, one month and three months after the beginning of the study. Method of measurement: The Neurothesiometer. 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. Tehran University of Medical Sciences Approved 2023-10-08 Ethics Committee of Endocrine and Metabolism Research Institute - Tehran University of Medical Scien No. 54 , Tandis street, Nelson Mondela street, Tehran Tehran Tehran Iran (Islamic Republic of)