]>
IRCT20190210042676N7 IRCT 2020-05-19 SinaCell Knowledge-based production Company Evaluation of efficacy and safety of dermal substitute (Sinaderm) Evaluation of efficacy and safety of Sinaderm dermal substitute plus standard treatment (wet dressing) comparing standard treatment alone for healing chronic lower extremity diabetic ulcers 2020-05-21 anticipated 68 Complete https://irct.ir/trial/47546 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: An online site (https://www.sealedenvelope.com) will be used to generate a randomized list of study groups. According to the random block method and considering the four blocks, 17 blocks will be produced for 68patients. 3 Personal history of diabetic foot ulcer. Intervention 1: Intervention group: human fibroblast-derived dermal substitute(sinaderm) plus wet dressing. sinaderm will be inserted once or twice according to physician opinion and wet dressing will be inserted over it. wet dressing will be changed each 72 hours till complete wound healing. Intervention 2: Control group: wet dressing by Normal saline which will be changed every 24 hours till complete wound healing. 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 further information.
public Aniseh Samadi
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8896 0880 aniseh_samadi@yahoo.com Tehran University of Medical Sciences scientific Alireza Firooz
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 7921 firozali@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Signing the consent form for participation in the study Men or women with type I or II diabetes mellitus and neuropathy disorder 3 (defined by Michigan diabetic neuropathy score) At least 1, but no more than 2, partial thickness neuropathic ulcer (stage I and II as defined by Wagner staging system) located on the lateral foot, plantar arch, forefoot, , heel, or toe The target ulcer have an area, after debridement between 3 and 25 cm2 The target ulcer has been present for at least 4 weeks at the time of the baseline visit 18 years 60 years Both Patients with ulcers resulting from electrical, chemical, or radiation burns or venous insufficiency Patients with ulcers resulting from amputation Uncontrolled infection or necrosis or cellulitis at the site of the target ulcer Chronic renal insufficiency (serum creatinine > 2.5) Uncontrolled hyperglycemia (HbA1c > 10%) Administration of some medications (chemotherapy, immune suppressants, corticosteroids or radiotherapy) within past 30 days Pregnancy or lactating Heavy smokers Z86.31 Personal history of diabetic foot ulcer Treatment - Devices Treatment - Devices Intervention group: human fibroblast-derived dermal substitute(sinaderm) plus wet dressing. sinaderm will be inserted once or twice according to physician opinion and wet dressing will be inserted over it. wet dressing will be changed each 72 hours till complete wound healing. Control group: wet dressing by Normal saline which will be changed every 24 hours till complete wound healing. Area of ​​wound compared to baseline. Timepoint: Before the intervention and once a week for 8 weeks. Method of measurement: Checkered paper. The percentage of patients who responded 50% to treatment. Timepoint: Once a week for 8 weeks. Method of measurement: counting the respounders. Patients' satisfaction. Timepoint: Once a week for 8 weeks. Method of measurement: Questionnaire.Patent will declare his or her satisfaction in case of the compatibility of the dressings , its help to reduce the pain and also improving the wound using five-grade Likert scale (5= extremely satisfied, 4= very satisfied, 3= moderately satisfied, 2= slightly satisfied, 1= dissatisfied). SinaCell Knowledge-based production Company Approved 2020-04-29 Ethics committee of Tehran University of Medical Sciences Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)