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IRCT20190214042712N1 IRCT 2019-09-17 Iran National Science Foundation The use of stem cells loaded on nanofiber tissue scaffolds to repair the diabetic foot ulcer Investigation of the therapeutic potential of fibroblast and adipose-derived mesenchymal stem cells loaded on nanofiber scaffolds for healing the diabetic foot ulcer in diabetic patients and comparison with common procedures. 2015-09-23 anticipated 20 Complete https://irct.ir/trial/37728 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done by a random number table. N/A Diabetic foot ulcer. Intervention 1: Intervention group: Diabetic patients with foot ulcer will receive stem cell therapy in addition to routine treatment. The stem cells will be loaded on nanofiber scaffolds in the central lab to prepare and then use the bandages. The treatment sessions will take one to two months, such that in each week one bandage will be put on the foot of patients topically. The patients are regularly visited twice in a week. Intervention 2: Control group: Diabetics patients with foot ulcer will only receive routine treatments including debridement, Prescribing antibiotics, wound cleaning, and normal dressing. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Rokhsareh Meamar
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 meamar@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Rokhsareh Meamar
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 73461-81746 +98 31 3668 0048 meamar@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 21 to 65 years old Having diabetic foot wounds that have not recovered despite a cure during the past month (2-7 cm) Feeling pain at rest and walking Signature written consent 21 years 65 years Both Patients over 65 years old Pregnancy or breastfeeding The presence of septicemia Other systemic diseases in which the kidney is involved, such as cancer, autoimmune diseases, blood diseases, liver disease and ... Hospitalization due to serious illness in the past two months Severe malnutrition The presence of foot ulcer due to all reasons except for diabetes, for example, syphilis, tuberculosis, or fungal foot Any allergy to the compounds used in the cell culture process E14.5 Diabetes mellitus with peripheral circulatory complications Treatment - Other N/A Intervention group: Diabetic patients with foot ulcer will receive stem cell therapy in addition to routine treatment. The stem cells will be loaded on nanofiber scaffolds in the central lab to prepare and then use the bandages. The treatment sessions will take one to two months, such that in each week one bandage will be put on the foot of patients topically. The patients are regularly visited twice in a week. Control group: Diabetics patients with foot ulcer will only receive routine treatments including debridement, Prescribing antibiotics, wound cleaning, and normal dressing. Wound size based on cm2. Timepoint: Before treatment and at every 1 and 2 weeks after treatment. Method of measurement: By multiplying the length of the wound by depth of the wounds. The distance that the patient can walk without pain. Timepoint: Before treatment and at every 1 and 2 weeks after treatment. Method of measurement: Meter. Biochemical markers including ALT, AST, Bilirubin, FBS, TG, Cholesterol, BUN, Cr. Timepoint: Before and after treatment. Method of measurement: Biochemical tests. Iran National Science Foundation Approved 2019-06-25 Research Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)