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IRCT138812133487N1 IRCT 2010-04-03 Isfahan University of Medical Sciences To evaluate new cellular therapy for non-healing diabetic foot ulcer To evaluate the efficacy and safety of applied autologous circulating fibrocytes in the treatment of non-healing diabetic foot ulcer; a pilot study 2010-05-01 anticipated 20 Complete https://irct.ir/trial/3599 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 1 Non-healing diabetic foot ulcer. Intervention 1: cell graft plus dressing (cell suspension) applied once over the wound, but the dressing will be changed weekly to the time of wound healing or up to the 8 week. Intervention 2: Control group receive dressing without cellular graft, and the dressing will be changed every 7 days up to the 8 week or the complete wound healing. Int Wound J. 2013 Apr 2. doi: 10.1111/iwj.12043. [Epub ahead of print]<br /> <br /> Safety, efficacy and pitfalls of fibrocyte application in the treatment of diabetic foot ulcer.<br /> <br /> Behjati M, Hashemi M, Shoarayenejati A, Karbalaie K, Nasr-Esfahani MH.<br /> <br /> <br /> Source<br /> <br /> Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.<br /> <br /> <br /> Abstract<br /> <br /> <br /> Fibrocytes are unique bone marrow-derived cells with great potential in wound healing. Hence, the aim of this study was to determine the safety and efficacy of the applied circulating fibrocytes in the treatment of non healing diabetic foot ulcers. Peripheral blood mononuclear cells were isolated by centrifugation through Ficoll-Paque method. After 3 days, the non adherent cells were removed by a single, gentle aspiration. Adherent cells were cultured in the same medium for 10 days. The cells were characterised using mouse anti-human-CD45-fluorescein isothiocyanate (FITC) and mouse anti-human-collagen I, and also characterised by immunofluorescence microscopy using the above mentioned antibodies. Sterility measures were applied for clinical evaluation. Based on the literature review, cell transplantation generally requires at least 3 × 106 cells regarding efficacy measures. As fibrocytes are non proliferating cells, 350 ml patient's blood is required to prepare patient-specific serum before cell isolation and culture, and 85 ml patient's blood is needed for cell isolation and differentiation on cell transplantation applications. In our survey, no diabetic patient was inclined to be donor of such blood volume, mainly because of their pre-assumption that they are anaemic. It is concluded that fibrocytes do not seem to be<br />
public Mohaddeseh Behjati
Isfahan University of Medical Sciencecs, Dept. of Genetics
Isfahan Iran (Islamic Republic of) +98 31 1792 2415 behjati@med.mui.ac.ir Isfahan University of Medical Sciences scientific Mohaddeseh Behjati
Isfahan University of Medical Sciences, Dept. of Genetics
Isfahan Iran (Islamic Republic of) +98 31 1792 2415 behjati@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: both males and females, age 40-70 years old, with wounds area ranging from 2 to 6 cm2, (exposed bones may also be included if other criteria are filled), healing refractory despite comprehensive treatment for at least 6 weeks and Grade II, III and IV of Wagner's classification system (wound will be debrided), Wounds in the Gangrene stage are included if they are wet, but suppurative wounds may be enrolled after complete treatment of the infection. Mostly wounds with the cavity formation will be preferred to enrolled, as in the cases after debridement with a remained cavity unfilled with healed tissues, compliant, alert enough to understand the process of the research project which are high risk for amputation and are not indicated for vascular surgery or are unable to endure surgery are considered to be included. Exclusion criteria: Non-healing wounds with clinically or laboratory (ESR, CBC, CRP) diagnosed osteomyelitis, cellulitis or any kind of infection before infection control, Dry gangrene which makes no problem for the patient, patients with overt malignancy, chronic kidney disease over stage III, uncontrolled hyperglycemia (HbA1C> 9%) and other underlying disease other than DM (based on their files and caring physician information), other causes of non-inclusion are pregnancy, lactation, Poor hygiene, Consumption of special drugs with the effect on wound healing. patients with mental or psychological disorders and cases who are unable to understand or perceive the process of getting informed consent completely. 40 years 70 years Both E11.5 Non-insulin-dependent diabetes mellitus With peripheral circulatory complications. Diabetic ulcer Other Other cell graft plus dressing (cell suspension) applied once over the wound, but the dressing will be changed weekly to the time of wound healing or up to the 8 week Control group receive dressing without cellular graft, and the dressing will be changed every 7 days up to the 8 week or the complete wound healing. Wound area. Timepoint: every 7 days up to 8th week then bi-weekly up to 6 months. Method of measurement: Paper ruler, digital camera, lab data and clinical observation. Patient satisfaction scores. Timepoint: at 2-6-9-12 months. Method of measurement: patient satisfaction scores based on the VAS scoring system. Occurrence of unexplained fever, weight loss. Timepoint: every 7 days up to 8th week then bi-weekly up to 6 months. Method of measurement: clinical observation. Wound healing process. Timepoint: every 7 days up to 8th week then bi-weekly up to 6 months. Method of measurement: Paper ruler, digital camera, lab data and clinical observation. Local complications. Timepoint: every 7 days up to 8th week then bi-weekly up to 6 months. Method of measurement: clinical observation. Clinical or laboratory abnormalities. Timepoint: 3, 6, 12 and 19th months. Method of measurement: lab data and clinical observation. Wound healing time. Timepoint: every 7 days up to 8th week then bi-weekly up to 6 months. Method of measurement: Paper ruler, digital camera, lab data and clinical observation. Need to amputation. Timepoint: 3, 6, 12 and 19th months. Method of measurement: Clinical observation, lab data. Abnormal renal or hepatic function tests. Timepoint: 3, 6, 12 and 19th months. Method of measurement: lab data. Mortality. Timepoint: from the begining of the study up to the 19th months. Method of measurement: Death occurrence. Royan Research Center Isfahan University of Medical Sciences Royan Research Center Approved Ethics committee of Isfahan University of Medical Sciences Ethics Committee, Vice-chancellory for research, Isfahan University of Medical Sciences Isfahan Iran (Islamic Republic of)