]>
IRCT20210212050334N2 IRCT 2021-10-20 Rasht University of Medical Sciences Evaluation of safety and efficacy of stromal vascular fraction on foot diabetic wound-clinical trial phase I and II Evaluation of safety and efficacy of stromal vascular fraction on foot diabetic wound-clinical trial phase I and II 2021-12-22 anticipated 62 Complete https://irct.ir/trial/59115 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, the block randomization method will be used. In this study, by equalizing the size of the blocks, blocks of size 6 (three participants in the intervention group and three participants in the control group) will be used. Related software, R software package, will be used. We use the opaque sealed envelopes method for concealment. Random sequences will be written on the cards. Then the cards will be placed inside the envelope. In order to maintain the created random sequence, numbers will be written on the outer surface of the envelopes. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the project, one of the envelopes will be opened in order and the assigned group of that participant is revealed according to the order of entry of eligible participants, Blinding description: In this research, the single-blind method will be used. Due to the removal of fat by the physician from the patient, blinding of physician and evaluators will not be possible. Only the person who will assign the groups (investigator) will be blind. 1-2 Diabetic foot ulcers. Intervention 1: Intervention group: The prepared SVF will be injected in the desired areas with a depth of 1 to 2 mm in a width of 1%, equal to 10 by 17 cm at intervals of 1 in 1 cm with a volume of 0.1 cc, using the mesogan device. Intervention 2: Control group: The control group will not receive the placebo and no intervention will be performed for them. This group will receive all routine treatments. Yes - There is a plan to make this available What will be shared: Age,sex, side effect When: After publishing the results in the article To whom: Universities Conditions: only for study Where to obtain: Dr.Amaneh Mohammadi Roushandeh Email: mohammadi_roushandeh@gums.ac.ir How to obtain: The request must be written to the Vice Chancellor for Research of Guilan University of Medical Sciences. The request is sent to the principal investigator and the researcher will send the documents to the deputy. The applicant can receive the documents from the deputy. Comments:
public Amaneh mohammadi roushandeh
3th floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 mohammadi_roushandeh@gums.ac.ir Rasht University of Medical Sciences scientific Amaneh Mohammadi Roushandeh
3th floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 mohammadi_roushandeh@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Having chronic outpatient diabetic foot ulcer Age range from 30 to 60 years Having a single wound on the foot and limb terminals (fingers, sole, heel, toes) within four works without repair Body Mass index 18-25 ABI / TBI ratio greater than 0.9. 30 years 60 years Both Smoking, Alcohol consumption Drug addiction Taking drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents. A concomitant disease that may interfere with wound healing, such as cancer, vasculitis, kidney, liver, or heart failure. Osteomyelitis E11.621 Type 2 diabetes mellitus with foot ulcer Treatment - Other Treatment - Drugs Intervention group: The prepared SVF will be injected in the desired areas with a depth of 1 to 2 mm in a width of 1%, equal to 10 by 17 cm at intervals of 1 in 1 cm with a volume of 0.1 cc, using the mesogan device. Control group: The control group will not receive the placebo and no intervention will be performed for them. This group will receive all routine treatments. Mortality rate. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Patient record. Adverse systemic complications. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Barometer and diagnostic tests. Fever. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Thermometer. Infection. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Examination of the wound by the treating physician. Wound healing. Timepoint: 1,7, 28 and 60 days after SVF injection. Method of measurement: Examination, wound diameter decreases. Wound edema. Timepoint: 1,7, 28 and 60 days after SVF injection. Method of measurement: Medical examinations and checklist. Neuropathy. Timepoint: 1,7, 28 and 60 days after SVF injection. Method of measurement: Physician diagnosis and check list. Rasht University of Medical Sciences Approved 2021-09-14 Ethics Committee of Guilan University of Medical Sciences 3th floor, Burn and Regenerative Medicine ResearchCenter, Velayat Hospital, Namjo street, Rasht, Guilan Rasht Guilan Iran (Islamic Republic of)