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IRCT20130811014330N9 IRCT 2023-09-25 Mashhad University of Medical Sciences Human stromal vascular fraction(SVF) and platelet-rich plasma(PRP) in treatment of therapy-resistant diabetic foot ulcers The use of human stromal vascular fraction(SVF) and platelet-rich plasma(PRP) in treatment of therapy-resistant diabetic foot ulcers: a randomized control trial phase III 2023-08-23 anticipated 20 Complete https://irct.ir/trial/72199 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: block Build random sequences: Randomization website (Randomaize.com) Allocation Concealment: SNOSE (sequentially numbered, opaque, sealed envelopes) According to the two intervention and control groups, the number of each block will be five. Then, write a list of blocks and assign numbers to them, which will be four blocks according to the sample size of 20 people. After that, random numbers between one and four are selected according to the randomization website (Randomaize.com). Finally, the allocated treatment list is written based on random numbers on the envelopes. 3 Diabetic foot ulcer. Intervention 1: Control group: As the control group, the common treatment for the patient is considered. The common treatment for these patients is a combined treatment including surgery, infection control, etc., which is prescribed to the patient at the discretion of the treatment staff and depending on the type and severity of the wound. Intervention 2: Intervention group: In this group, the diabetic wound is treated with PRP twice a week for one month. In this way, in each session, 50 ml of blood is taken from the patient in a tube containing citrate phosphate dextrose or sodium citrate anticoagulant. PRP is prepared from the patient's plasma according to the protocol. The necrotic part of the wound is surgically removed by the attending physician and after washing the wound three times with hydrogen peroxide and normal saline, the wound is photographed. Then, depending on the area of the wound, up to 5 ml (per session) of PRP solution prepared by the surgeon is injected. It should be noted that the injection is done at several points of the edges of the wound so that the environment of the edge of the wound is properly covered. After that, the wound is bandaged with a wet silicone bandage. Intervention 3: Intervention group: About 100 ml of the patient's fat tissue is collected by the negative-pressure liposuction technique in an autologous manner from the patient himself through surgery. Then, the fat tissue taken in sterile conditions under the laminar hood is transformed into smaller pieces with a surgical blade, and the amount of blood remaining in it will be removed after washing twice with normal saline. The total volume of SVF solution is 60 cc, and it contains 30 x 106 live cells for one injection in the study. The injection method is that 20 cc of SVF solution containing 10 x 106 live cells will be injected into the subcutaneous tissues around the wound (with low injection volumes, 0.5 cc). Another 20 cc of SVF solution containing 10 x 106 live cells will be injected into the wound bed (with low injection volumes, 0.5 cc). 10 cc of SVF solution containing 5 x 106 viable cells will be injected at the level of the ankle, parallel to the anterior tibial artery, and pedis dorsalis (with low injection volumes, 0.5 cc). 10 cc of SVF containing 5 x 106 viable cells will be injected at the level of the ankle, parallel to the posterior tibial artery (with low injection volumes, 0.5 cc). The injection will be done after removing the necrotic part of the wound by surgery and after washing the wound three times with hydrogen peroxide and normal saline, the wound will be photographed and then the injection will be done according to the described method. Intervention 4: Intervention group: PRP+SVF treatment is used in this group. For this reason, SVF is separated like the second group. The volume of 30 cc of SVF contains 15 x 106 live cells for one injection. The injection method is that 10 cc of SVF containing 5 x 106 live cells will be injected into the subcutaneous tissues around the wound (with low injection volumes, 0.5 cc). 10 cc of SVF containing 5 x 106 viable cells will be injected into the wound bed (with low injection volumes, 0.5 cc). 5 cc of SVF containing 2.5 x 106 viable cells will be injected at the level of the ankle, parallel to the anterior tibial artery, and pedis dorsalis (with low injection volumes, 0.5 cc). 5 cc of SVF containing 2.5 x 106 viable cells will be injected at the level of the ankle, parallel to the posterior tibial artery (with low injection volumes, 0.5 cc). In this group, for the treatment with PRP, about 50 ml of autologous blood is taken from the patient and PRP is prepared like the RPR preparation protocol in the first group. In this group, the injection will be once a week for a month. Depending on the area of the wound, up to 5 ml (per session) of PRP solution prepared by the surgeon is injected. It should be noted that the injection is done at several points of the edges of the wound so that the environment of the edge of the wound is properly covered. After that, the wound is bandaged with a wet silicone bandage. Wet silicone dressing is changed every three days. Yes - There is a plan to make this available What will be shared: Clinical documentation is published with confidentialy When: One year after the end of sampling To whom: َAvailable for people working in academic institutions Conditions: For further research Where to obtain: Dr. Hamid Reza Rahimi How to obtain: Approved by the Research Committee of Mashhad Medical University Comments:
public Hamid Reza Rahimi
Faculty of Medicine, Azadi Square, Pardis Campus
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 1800 2288 rahimi@mums.ac.ir Mashhad University of Medical Sciences scientific Hamid Reza Rahimi
Faculty of Medicine, Azadi Square, Pardis Campus
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 1800 2288 rahimihr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Having a diabetic ulcer grade 1 to 4 according to Wagner's classification Having a single wound in the legs and extremities (fingers, soles, heels, on the toes) that has been at least 4 weeks old No smoking, alcohol and drug addiction Not taking drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents Not having concurrent diseases such as cancers, vasculitis, kidney and liver failure, and heart failure that may cause problems in wound healing Informed consent of patients no limit no limit Both Patients with acute bone inflammation or osteomyelitis A wound with visible bone in the target area of treatment Infected diabetic foot ulcers Charcot deformity History of treatment with chemotherapy drugs or radiation therapy in 3 months before the start of treatment Hemoglobin less than 10mg/dL History of treatment with growth factors during two weeks before starting treatment Patients with less than 100,000 platelets Vascular problems should not be observed in the wound (not ABI˂0.7) Z86.31 Personal history of diabetic foot ulcer Other Treatment - Other Treatment - Other Treatment - Other Control group: As the control group, the common treatment for the patient is considered. The common treatment for these patients is a combined treatment including surgery, infection control, etc., which is prescribed to the patient at the discretion of the treatment staff and depending on the type and severity of the wound. Intervention group: In this group, the diabetic wound is treated with PRP twice a week for one month. In this way, in each session, 50 ml of blood is taken from the patient in a tube containing citrate phosphate dextrose or sodium citrate anticoagulant. PRP is prepared from the patient's plasma according to the protocol. The necrotic part of the wound is surgically removed by the attending physician and after washing the wound three times with hydrogen peroxide and normal saline, the wound is photographed. Then, depending on the area of the wound, up to 5 ml (per session) of PRP solution prepared by the surgeon is injected. It should be noted that the injection is done at several points of the edges of the wound so that the environment of the edge of the wound is properly covered. After that, the wound is bandaged with a wet silicone bandage. Intervention group: About 100 ml of the patient's fat tissue is collected by the negative-pressure liposuction technique in an autologous manner from the patient himself through surgery. Then, the fat tissue taken in sterile conditions under the laminar hood is transformed into smaller pieces with a surgical blade, and the amount of blood remaining in it will be removed after washing twice with normal saline. The total volume of SVF solution is 60 cc, and it contains 30 x 106 live cells for one injection in the study. The injection method is that 20 cc of SVF solution containing 10 x 106 live cells will be injected into the subcutaneous tissues around the wound (with low injection volumes, 0.5 cc). Another 20 cc of SVF solution containing 10 x 106 live cells will be injected into the wound bed (with low injection volumes, 0.5 cc). 10 cc of SVF solution containing 5 x 106 viable cells will be injected at the level of the ankle, parallel to the anterior tibial artery, and pedis dorsalis (with low injection volumes, 0.5 cc). 10 cc of SVF containing 5 x 106 viable cells will be injected at the level of the ankle, parallel to the posterior tibial artery (with low injection volumes, 0.5 cc). The injection will be done after removing the necrotic part of the wound by surgery and after washing the wound three times with hydrogen peroxide and normal saline, the wound will be photographed and then the injection will be done according to the described method. Intervention group: PRP+SVF treatment is used in this group. For this reason, SVF is separated like the second group. The volume of 30 cc of SVF contains 15 x 106 live cells for one injection. The injection method is that 10 cc of SVF containing 5 x 106 live cells will be injected into the subcutaneous tissues around the wound (with low injection volumes, 0.5 cc). 10 cc of SVF containing 5 x 106 viable cells will be injected into the wound bed (with low injection volumes, 0.5 cc). 5 cc of SVF containing 2.5 x 106 viable cells will be injected at the level of the ankle, parallel to the anterior tibial artery, and pedis dorsalis (with low injection volumes, 0.5 cc). 5 cc of SVF containing 2.5 x 106 viable cells will be injected at the level of the ankle, parallel to the posterior tibial artery (with low injection volumes, 0.5 cc). In this group, for the treatment with PRP, about 50 ml of autologous blood is taken from the patient and PRP is prepared like the RPR preparation protocol in the first group. In this group, the injection will be once a week for a month. Depending on the area of the wound, up to 5 ml (per session) of PRP solution prepared by the surgeon is injected. It should be noted that the injection is done at several points of the edges of the wound so that the environment of the edge of the wound is properly covered. After that, the wound is bandaged with a wet silicone bandage. Wet silicone dressing is changed every three days. The size of the wound. Timepoint: before dressing and after dressing in the first, second, third, and fourth week after treatment and then in the second, fourth, and sixth months after intervention. Method of measurement: Digital photographic camera, sterile metal ruler. Wound depth. Timepoint: before dressing and after dressing in the first, second, third, and fourth week after treatment and then in the second, fourth, and sixth months after intervention. Method of measurement: Sterile metal measuring cup. Stress oxidative markers. Timepoint: 6 Months after intervention. Method of measurement: Gene expression level by Real time PCR. Angiogenesis and inflammation markers. Timepoint: 6 Months after intervention. Method of measurement: Gene expression level by Real time PCR. MiRNA levels in serum of peripheral blood. Timepoint: 6 Months after intervention. Method of measurement: Gene expression level by Real time PCR. Mashhad University of Medical Sciences Approved 2023-07-01 Ethics committee of Mashhad University of Medical Sciences Quraishi bilding of MUMS, Daneshgah St., Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)