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IRCT2016072629078N1 IRCT 2016-10-08 Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences The effects of Traditional medicine product in Diabetic Foot Ulcer The effect of Aloe vera and Plantago Major gel in Diabetic Foot Ulcers in patients with type 2 diabetes. 2016-10-22 anticipated 40 Complete https://irct.ir/trial/23454 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Diabetic Foot Ulcer. Intervention 1: In the control group, placebo topical (gel containing only basis) also trained twice a day by the patient or the patient up to 28 days to five millimeters in diameter is applied on the wound and finally covered with sterile gauze and tape is latex-free. Intervention 2: In the intervention group Aloe vera 10% gel and Hydroalcholic extract of leave of Plantago Major (Aloe Vera 5% resin and Plantago Major 5% extract ) with trained twice a day by the patient or the patient up to 28 days to five millimeters in diameter is applied on the wound and finally covered with sterile gauze and tape is latex-free.
public Yones Najafian Razavi
East Razi Ave, Opposite the Mehran sports hall, Faculty of Iranian Traditional Medicine and Complementary
Mashhad Iran (Islamic Republic of) +98 51338552188 najafiany921@mums.ir; yones_dr@yahoo.com Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences scientific Zohre Feyzabadi
East Razi Ave, Opposite the Mehran sports hall, Faculty of Iranian Traditional Medicine and Complementary
Mashhad Iran (Islamic Republic of) +98 51 3855 2188 Feyzabadiz@mums.ac.ir Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Type II diabetes for at least 5 years; Age between 30 to 65 years; BMI greater than 18 and less than 35; Diagnosis of neuropathic diabetic foot ulcer Wagner grade 1 or 2 Moderate infection by Internal expert; HbA1C <10; Exclusion criteria: Lack of patient follow-up; Lack of satisfaction in every stage of the study; Failure to respond to treatment; Create complications in the study conducted by treatment; Acute or severe complications of diabetes, exacerbation of underlying disease; Other systemic diseases ; Tobacco, Alcohol, Cytotoxic, Glucocorticoid, Immunosuppressive drugs; Pregnancy and lactation; Sensitivity to Aloe vera and Plantago Major plants; Diabetic foot ulcer grade 3 to 5 Wagner; Suspected osteomyelitis ( lesion size of more than 2 square centimeters ) 30 years 65 years Both E10.5 Insulin-dependent diabetes mellitus with peripheral circulatory complications Placebo Treatment - Drugs In the control group, placebo topical (gel containing only basis) also trained twice a day by the patient or the patient up to 28 days to five millimeters in diameter is applied on the wound and finally covered with sterile gauze and tape is latex-free. In the intervention group Aloe vera 10% gel and Hydroalcholic extract of leave of Plantago Major (Aloe Vera 5% resin and Plantago Major 5% extract ) with trained twice a day by the patient or the patient up to 28 days to five millimeters in diameter is applied on the wound and finally covered with sterile gauze and tape is latex-free. The area of ​​the wound. Timepoint: Baseline, the end of the study. Method of measurement: Ruler and Imaging. Deep wounds. Timepoint: Baseline, the end of the study. Method of measurement: A sterile swab. Wound symptoms. Timepoint: Baseline, the end of the study. Method of measurement: Secretion, Edema, Erythema And Desquamation. HbA1c. Timepoint: Baseline, the end of the study. Method of measurement: Laboratory blood test. Urea. Timepoint: Baseline, the end of the study. Method of measurement: Laboratory blood test. 2Hpp. Timepoint: Baseline, the end of the study. Method of measurement: Laboratory blood test. CBC. Timepoint: Baseline, the end of the study. Method of measurement: Laboratory blood test. FBS. Timepoint: Baseline, the end of the study. Method of measurement: Laboratory blood test. Blood pressure. Timepoint: Baseline, the end of the study. Method of measurement: Manometer. Creatinine. Timepoint: Baseline, the end of the study. Method of measurement: Laboratory blood test. Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences Approved 2016-06-18 Ethics committee of Mashhad University of Medical Sciences Daneshgah Ave, Building Qureshi, Mashhad University of Medical Sciences Administration Mashhad Iran (Islamic Republic of)