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IRCT20190526043711N1 IRCT 2019-09-02 Mashhad University of Medical Sciences The effect of combination therapy of vitamin E and C supplements plus Platelet-Rich Plasma-Fibrin Glue on biochemical factors, oxidative stress markers and wound healing rate in diabetic patients The effect of combination therapy of vitamin E and C supplements plus Platelet-Rich Plasma-Fibrin Glue on biochemical factors, oxidative stress markers and wound healing rate in diabetic patients 2019-08-23 anticipated 24 Complete https://irct.ir/trial/39839 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The data analyst will not be aware of the allocation of individuals in the groups analyzed and reviewed. 2-3 Diabetic foot ulcer. Intervention 1: Control group: Patients with diabetic ulcer treated with PRP-Fibrin-Glue for 8 weeks. Intervention 2: Intervention group: Patients with diabetic ulcer treated with PRP-Fibrin-Glue plus vitamin supplements (E (200 IU / 2day) and C (250 mg / 2day) ) for 8 weeks. Yes - There is a plan to make this available What will be shared: All data related to the project after unidentifiable of people will be shared. When: Access to data are allowed 6 months after the publication of results. To whom: Our data will be available for university staffs and academic institutions. Conditions: All types of analysis for data are allowed by authorized researchers. Where to obtain: yarahmadiA961@mums.ac.ir How to obtain: Accept permission from the project implementer for the applicant Comments:
public Daryoush Hamidi Alamdari
Iman Reza Hospital, Daneshgah Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3882 8574 hamidiad@mums.ac.ir Mashhad University of Medical Sciences scientific Daryoush Hamidi Alamdari
Iman Reza Hospital, Daneshgah Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3882 8574 hamidiad@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with grade 2- 4 diabetic wounds based on Wagner's classification Having wounds on the legs and extremities No smoking, alcohol or drug addiction Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents. Not having an illness that may cause problems in wound healing, such as cancers, vasculitis Age between 40 and 75 years HbA1c over 7 within last 3 months At least 4 weeks have elapsed since the wounds occurred 40 years 75 years Both The presence of ulcer with active infection and the need for intravenous antibiotics Gangrene which needs amputation Lack of patient referral to the center for tracking and changing dressings in more than two occasions Previous consumption of vitamin E and C supplements Patients with renal and hepatic failure and heart failure Patients with advanced diabetic retinopathy Pregnancy or breastfeeding HbA1c more than 11 Occurrence of special medical conditions E10-E14 With peripheral circulatory complications Treatment - Other Treatment - Drugs Control group: Patients with diabetic ulcer treated with PRP-Fibrin-Glue for 8 weeks. Intervention group: Patients with diabetic ulcer treated with PRP-Fibrin-Glue plus vitamin supplements (E (200 IU / 2day) and C (250 mg / 2day) ) for 8 weeks. Healing rate of the ulcer. Timepoint: At the beginning of the study, and then every week for 2 months. Method of measurement: Examination by a vascular surgery physician and documentation. The size of the ulcer. Timepoint: At the beginning of the study, and then every week for 2 months. Method of measurement: Measuring by ruler and documentation. Serum hs-CRP. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Fasting blood sugar. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum insulin. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum Triglyceride. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum Cholesterol. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum HDL. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum LDL. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum Urea. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum Creatinine. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum total bilirubin. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. HbA1c. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum Uric acid. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum Malondialdehyde. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum reduced Glutathione. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Total Antioxidant Capacity. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum levels of vitamins E. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Serum levels of vitamins C. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: In a quantitative laboratory method. Mashhad University of Medical Sciences Approved 2019-05-25 Ethics committee of Mashhad University of Medical Sciences Iman Reza Hospital, Daneshgah Ave Mashhad Razavi Khorasan Iran (Islamic Republic of)