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IRCT20151020024625N7 IRCT 2018-04-23 Semnan University of Medical Sciences Efficacy of cryotherapy along laser therapy and laser therapy alone on diabetic foot ulcers Comparison between cryotherapy along laser therapy effects and specific laser therapy effects alone on diabetic foot ulcers, a randomized clinical trial 2018-04-21 anticipated 30 Complete https://irct.ir/trial/30459 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into three groups by randomization blocks. 2-3 Diabetic foot ulcer. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: Patients in this group will receive only routine therapies. Yes - There is a plan to make this available What will be shared: Results of statistical Analysis When: After completing the project To whom: Only the study researchers and Referee Conditions: For similar studies Where to obtain: Dr. Majid Forootan How to obtain: Calling and Email Comments:
public Majid Forootan
Basidj Boulevard
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2120 dr_forotan@yahoo.com Semnan University of Medical Sciences scientific Majid Forootan
Basidj Boulevard
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2120 dr_forotan@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) 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. 50 years no limit Both 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 E13.51 Other specified diabetes mellitus with diabetic peripheral angiopathy without gangrene Treatment - Devices Treatment - Devices Treatment - Other 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. 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. Control group: Patients in this group will receive only routine therapies. Reduction in diabetic foot ulcer size. Timepoint: 30 days after intervention. Method of measurement: Physical Examonation. Semnan University of Medical Sciences Approved 2018-02-06 Ethical Committee, Semnan University of Medical Sciences Basidj Boulevard Semnan Semnan Iran (Islamic Republic of)