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IRCT20130811014330N11 IRCT 2026-04-17 Mashhad University of Medical Sciences Investigation of the safety of allogeneic mesenchymal stem cell transplantation derived from adipose tissue in patients with diabetes A Comparative Evaluation of the safety of acellular dermal matrix transplantation combined with adipose-derived mesenchymal stem cells versus standalone adipose-derived mesenchymal stem cell injection in the traetment of diabetic foot ulcers refractory to standard thrapies 2026-04-21 anticipated 9 Complete https://irct.ir/trial/88682 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 diabetic foot ulcer. Intervention 1: Control group: The patients in the control group are treated with routine dressing. 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 1: The locally administration of 1.5 x 10^6 adipose-derived stem cells (ADSCs) (allogen, viracell) in days of 0, 7, 14, 21 (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 the cell 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. Intervention 3: Intervention group 2: The combination therapy of locally administration of 1.5 x 10^6 adipose-derived stem cells (ADSCs) (allogen, viracell) and acellular dermal matrix in days of 0, 7, 14, 21 (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 the cell 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 first with acellular dermal matrix and then 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 will be published while maintaining confidentiality principles. When: One year after the end of sampling To whom: researchers working in academic and scientific institutions Conditions: For further and supplementary research Where to obtain: Dr Hamid Reza Rahimi How to obtain: Approved by the Research Committee of Mashhad University of Medical Sciences Comments:
public Hamid Reza Rahimi
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran, Mashhad
Mashhad Iran (Islamic Republic of) 13944-91388 +98 51 3800 2301 rahimihr@mums.ac.ir Mashhad University of Medical Sciences scientific Hamid Reza Rahimi
Faculty of Medicine, Azadi Square, Pardis Campus,Vakil Abad Boulevard, Mashhad-Iran,
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 1800 2288 rahimihr891@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 receiving biological drugs Not having concurrent diseases such as cancers, vasculitis, kidney and liver failure, and heart failure that may cause problems in wound healing Vascular problems should not be observed in the wound (ankle-Brachial Index (ABI) should not be less than 0.7) no limit no limit Both patients with history of osteomyelitis Presence of exposed bone within the wound area patient with infected diabetic foot ulcer Concurrent participation in other clinical trials Hemoglobin less than 10mg/dL Other Treatment - Drugs Treatment - Drugs Control group: The patients in the control group are treated with routine dressing. 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 1: The locally administration of 1.5 x 10^6 adipose-derived stem cells (ADSCs) (allogen, viracell) in days of 0, 7, 14, 21 (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 the cell 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. Intervention group 2: The combination therapy of locally administration of 1.5 x 10^6 adipose-derived stem cells (ADSCs) (allogen, viracell) and acellular dermal matrix in days of 0, 7, 14, 21 (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 the cell 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 first with acellular dermal matrix and then with a wet silicone bandage. Wet silicone dressing is changed every three days. The size of the wound. Timepoint: before traetment and days of 7, 14, 21, 28 and 3 months after traetment. Method of measurement: Digital camera. Expression of inflammatory gene IL-6. Timepoint: before the intervention and 3 months after the completion of intervention. Method of measurement: Gene expression level by Real time PCR by TaqMan probe. Expression of inflammatory gene IL-1. Timepoint: before the intervention and 3 months after the completion of intervention. Method of measurement: Gene expression level by Real time PCR by TaqMan probe. Mashhad University of Medical Sciences Approved 2025-12-06 Ethics Committee of Mashhad University of Medical Sciences Qureshi Building of MUMS, University Street, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)