The effect of the boron-based gel on the treatment of diabetic foot ulcers: A prospective,randomized controlled trial |
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| Institution: | 1. Department of Genetics and Bioengineering, Faculty of Engineering, Yeditepe University, Istanbul, Turkey;2. Stem cell and regenerative medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran;3. Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Science, Tabriz, Iran;4. Faculty of Medicine, Department of General Surgery, Yeditepe University, Istanbul, Turkey;5. Department of Genetics and Bioengineering, Faculty of Engineering, Yeditepe University, Istanbul, Turkey;6. Cellular and Molecular Therapeutics Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD 20814, USA;7. Nutrition Research Center, Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran;8. Endocrine Research Center, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran;1. Drug Metabolism and Toxicology Research Laboratories, Department of Biochemistry, College of Medicine, University of Ibadan, Ibadan, Nigeria;2. Department of Anatomy, College of Medicine, University of Ibadan, Ibadan, Nigeria;3. Departamento de Bioquímica e Biologia Molecular, CCNE, Universidade Federal de Santa Maria, 97105-900 Santa Maria, RS, Brazil;1. Department of Thoracic Surgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, PR China;2. Department of Clinical Laboratory, Binzhou Medical University Hospital, Binzhou 256603, PR China;3. National Center for Orthopaedics, Department of Molecular Orthopaedics, Beijing Research Institute of Traumatology and Orthopaedics, Beijing Jishuitan Hospital, Beijing 100035, PR China;4. State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, PR China;5. College of Veterinary Medicine, China Agricultural University, Beijing 100083, PR China;6. State Key Laboratory of Medical Molecular Biology, Department of Biochemistry and Molecular Biology, Institute of Basic Medicine Sciences & School of Basic Medicine, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100005, PR China;1. Applied and Environmental Physiology Unit, Department of Physiology, University of Ibadan, Nigeria;2. Department of Human Physiology, College of Health Sciences, Nnamdi Azikiwe University, Nnewi Campus, Nigeria;1. School of Biopharmacy, China Pharmaceutical University, Nanjing 211198, PR China;2. School of Medicine, and Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210023, PR China;3. State Key Laboratory of Pharmaceutical Biotechnology, School of Life Sciences, Nanjing University, Nanjing 210023, PR China;1. Servicio de Pediatría Hospital, Clínico San Carlos, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain;2. Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain;3. Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, Spain;4. Unidad de investigación. Servicio de Medicina Preventiva, Hospital Clínico San Carlos, Madrid, Spain;5. Hospital Universitario de la Zarzuela, Madrid, Spain;6. Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain |
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| Abstract: | BackgroundChronic ulcers represent impaired healing capacity with high mortality in the elderly or patients with systemic disorders such as diabetes. Boron is an effective agent in wound healing by promoting cell migration and proliferation and reducing inflammation in the wound area. This study aimed to evaluate the therapeutic effect of a sodium pentaborate-based topical formulation compared to control on the treatment of diabetic foot ulcers.MethodsA prospective, double-blind, randomized controlled trial was conducted to apply randomly the topical sodium pentaborate 3% gel or topical conventional remedy (control) by patients diagnosed with diabetic foot ulcers. The 171 eligible participants aged 18–75 years received the allocated medicines twice a day for a month with an allocation ratio of 3:1. Twenty-five days and two months after the end of the trial, participants were reinvestigated for their ulcer condition and any recurrence. Wagner’s classification of diabetic foot ulcers was applied to this purpose (0−5).Results161 participants (57 females, 104 males; mean age: 59.37) completed this study. After the intervention, most participants in the intervention group had a lower ulcer grade than the control group (adjusted mean difference (95% CI): − 0.91 (−1.1 to −0.73); p < 0.001). Moreover, most participants in the intervention group (n = 109 (90.8%)) were treated at a higher rate than the control group (n = 5 (12.2%)) after intervention (adjusted odds ratio (95% CI): 0.008 (0.002–0.029); p < 0.001). There was no case of recurrence in the intervention group while its rate was (n = 2 (40%)) in the control group (p < 0.001).ConclusionThe present study suggests that topical sodium pentaborate gel may help treat and decrease the grade of diabetic foot ulcers and prevent the recurrence of diabetic foot ulcers. |
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| Keywords: | Sodium pentaborate Diabetic foot ulcer Randomized controlled trial |
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