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IRCT20111228008551N3 IRCT 2019-11-26 Tehran University of Medical Sciences The effect of Wound Healer on diabetic foot Evaluation of the effect of the herbal medicine Wound Healer on the healing of diabetic foot ulcers: A randomized double-blind clinical trial 2019-11-05 anticipated 80 Complete https://irct.ir/trial/41247 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients with diabetic foot ulcer are divided into two groups of "control and medication" based on the block randomization table after examination and if they meet the inclusion criteria. The doctor and nurse will not play a role in determining the treatment group, Randomization description: The sample randomization method will be based on the Block Randomization table. Patients with diabetic foot ulcer are divided into two groups of "control and medication" based on the block randomization table after examination and if they meet the inclusion criteria. The doctor and nurse will not play a role in determining the treatment group, Blinding description: Regarding of how the patients are randomly selected and the principal that investigator is separated from the treatment team, physicians and nurse practitioners will not play a role in selecting patients for treatment groups, and patients will be unaware of their treatment grouping. 3 Diabetic patient with infected foot ulcer. Intervention 1: Intervention group: Diabetic patients with infectious wounds who receive topical "Wound Healer" daily in addition to antibiotic treatment for 4 weeks daily. Intervention 2: Control group:Diabetic patients with infectious wounds, who receive their usual antibiotic treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dr. Mohammad Reza Amini
Shariati Hospital, North Kargar
Tehran Iran (Islamic Republic of) 1411413137 0089 21 88220037 mramini@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Mohammad Ansari
Medicine Faculty, Keshvarz Bld.
Tehran Iran (Islamic Republic of) 1411413137 +98 21 4444 6226 ansarimo@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Neuropathic, neuro-ischemic diabetic foot ulcer Signing informed consent to participate in the study No foot skin disease Diabetic foot patients with ulcer grades 1, 2, and 3 based on Wagner diagnostic criteria Age less than 70 years no limit 70 years Both Pregnancy and lactation Autoimmune diseases and cancer ŮŽAnkle-Brachial Index less than 0.7 People with HbA1c greater than 8% E11.6 Type 2 diabetes mellitus with other specified complications Treatment - Drugs Treatment - Drugs Intervention group: Diabetic patients with infectious wounds who receive topical "Wound Healer" daily in addition to antibiotic treatment for 4 weeks daily. Control group:Diabetic patients with infectious wounds, who receive their usual antibiotic treatment. 50% reduction in wound size. Timepoint: weekly. Method of measurement: The size of the wound is measured with a graded ruler and digitally photographed, and finally the image will be analyzed by ImageJ software. Drug Company Approved 2019-07-17 Endocrine & Metabolism Research Institute - Tehran University of Medical Science Diabetes Clinic, Shahrivar St, North kargar Ave. Tehran Tehran Iran (Islamic Republic of)