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IRCT20210422051040N1 IRCT 2023-03-30 Shahid Beheshti University of Medical Sciences Investigating the effectiveness of using platelet gel obtained from allogeneic umbilical cord blood in the treatment of foot ulcers in patients with diabetes Investigating the effectiveness of using platelet gel obtained from allogeneic umbilical cord blood in the treatment of foot ulcers in patients with diabetes: a phase 2 randomized clinical trial 2023-03-11 anticipated 20 Complete https://irct.ir/trial/67407 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Diabetes and healing. Intervention group: PLATELET GEL.Separation of platelet-rich plasma and centrifugation according to the protocol (15 minutes at 2450 g for platelet concentration). In the next step, to prepare the platelet gel, the enriched plasma is mixed with thrombin and calcium gluconate inside the blood bag of the sterile child and it can be used after half an hour. . The gels will be used locally in the wound without debridement of the intervention site. This operation will be done every other day for three days.. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main result or the like, can be shared. When: The access period starts 6 months after the results are published To whom: For researchers working in academic and scientific institutions Conditions: It can be used with the written permission of the owner of the idea Where to obtain: by Email How to obtain: Written permission from the person in charge and the owner of the work Comments:
public RASHIN MOHSENI
enghlab squre
تهران Iran (Islamic Republic of) 1417653761 ۸۱۶۳۱ · rashin_mohseni@yahoo.com Tehran University of Medical Sciences scientific hojjat allah abbaszadeh
velenjak
Tehran Iran (Islamic Republic of) 19395-4719 +98 21 23872 dr.abbaszadeh79@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The presence of diabetic foot ulcer criteria Ulcers in the leg tissue The wound area is more than 2 cm2 and less than 5 cm2 The patient does not have HIV, HBV, HCV, HTLV1 viral infections The patient does not have an acute bacterial infection Patient age from 40 to 70 years. Adherence to medication regimen by diabetic patients HbA1C in the normal range (HbA1C<6.5) 40 years 70 years Both Abuse of drugs and alcohol smoking Severe vascular diseases, lupus, rheumatoid arthritis, kidney failure Acute bacterial infection and sepsis Cancer and use of cytotoxic drugs E08 Diabetes mellitus due to underlying condition Treatment - Devices Intervention group: PLATELET GEL.Separation of platelet-rich plasma and centrifugation according to the protocol (15 minutes at 2450 g for platelet concentration). In the next step, to prepare the platelet gel, the enriched plasma is mixed with thrombin and calcium gluconate inside the blood bag of the sterile child and it can be used after half an hour. . The gels will be used locally in the wound without debridement of the intervention site. This operation will be done every other day for three days. Diabetic wound healing rate. Timepoint: Measure the recovery rate after 2 weeks, 1 month and 3 months. Method of measurement: Measuring the surface and depth of the wound. Shahid Beheshti University of Medical Sciences Approved 2023-03-06 Ethics Committee at Shahid Beheshti Medical University in Tehran, Iran Shahid Beheshti Medical University in Tehran tehran Tehran Iran (Islamic Republic of)