Diabetic foot ulcer. With peripheral circulatory complications
Conditions
Interventions
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 plu
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 lab | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDaryoush Hamidi Alamdari
Mashhad University of Medical Sciences
Outcome results
None listed