Diabetic patients who underwent long-term dialysis may increase the prevalence of foot ulceration. In addition, diabetic foot ulcer (DFUs) patients with end-stage renal disease (ESRD) do not heal well, and the amputation rate is 6.5 - 10 times higher compared to the non-nephropathic diabetic population. Thus, a suitable therapeutic agent was needed. ON101 is a topical cream that promotes diabetic wound healing through a unique macrophage-regulating ability. In this case series, we included 5 diabetes patients (mean age 54.6 ± 8.7 years, 4 mal) with ESRD (mean eGFR 7.4 ± 3.35 mL/min/1.73m2) and had experienced dialysis for at least 4.5 years. These patients also have UT (University of Texas) grade 2A DFUs that have existed for at least 1.5 months (mean ulcer duration 8.3 ± 8.97 months). These subjects were applied ON101 twice daily for up to 20 weeks, and wound size was recorded during treatment. Among these subjects, three ulcers (patient No. 1, 2, and 3) completely healed within 10 weeks upon ON101 application, and one ulcer was 99% reduced at 20th weeks (patient No. 4). Only one ulcer didn’t show an obvious response that may due to poor compliance in wound care and glucose control. In summary, the overall healing rate was 60%, suggesting ON101 performed equivalence healing efficacy in dialysis patients compared with those who did not have dialysis.
References
[1]
Cho, N.H., Shaw, J.E., Karuranga, S., et al. (2018) IDF Diabetes Atlas: Global Estimates of Diabetes Prevalence for 2017 and Projections for 2045. Diabetes Research and Clinical Practice, 138, 271-281. https://doi.org/10.1016/j.diabres.2018.02.023
[2]
Cole, J.B. and Florez, J.C. (2020) Genetics of Diabetes Mellitus and Diabetes Complications. Nature Reviews Nephrology, 16, 377-390. https://doi.org/10.1038/s41581-020-0278-5
[3]
Nacak, H., Bolignano, D., Van Diepen, M., et al. (2016) Timing of Start of Dialysis in Diabetes Mellitus Patients: A Systematic Literature Review. Nephrology Dialysis Transplantation, 31, 306-316. https://doi.org/10.1093/ndt/gfv431
[4]
Alalawi, F. and Bashier, A. (2021) Management of Diabetes Mellitus in Dialysis Patients: Obstacles and Challenges. Diabetology & Metabolic Syndrome, 15, 1025-1036. https://doi.org/10.1016/j.dsx.2021.05.007
[5]
Armstrong, D.G., Boulton, A.J.M. and Bus, S.A. (2017) Diabetic Foot Ulcers and Their Recurrence. The New England Journal of Medicine, 376, 2367-2375. https://doi.org/10.1056/NEJMra1615439
[6]
Schaper, N.C., van Netten, J.J., Apelqvist, J., et al. (2020) Practical Guidelines on the Prevention and Management of Diabetic Foot Disease (IWGDF 2019 Update). Diabetes/Metabolism Research and Reviews, 36, e3266. https://doi.org/10.1002/dmrr.3266
[7]
Ndip, A., Rutter, M.K., Vileikyte, L., et al. (2010) Dialysis Treatment Is an Independent Risk Factor for Foot Ulceration in Patients with Diabetes and Stage 4 or 5 Chronic Kidney Disease. Diabetes Care, 33, 1811-1816. https://doi.org/10.2337/dc10-0255
[8]
Game, F.L., Chipchase, S.Y., Hubbard, R., et al. (2006) Temporal Association between the Incidence of Foot Ulceration and the Start of Dialysis in Diabetes Mellitus. Nephrology Dialysis Transplantation, 21, 3207-3210. https://doi.org/10.1093/ndt/gfl427
[9]
Maroz, N. (2016) Impact of Renal Failure on Wounds Healing. Journal of the American College of Clinical Wound Specialists, 8, 12-13. https://doi.org/10.1016/j.jccw.2018.01.004
[10]
Lavery, L.A., Lavery, D.C., Hunt, N.A., et al. (2015) Amputations and Foot-Related Hospitalisations Disproportionately Affect Dialysis Patients. International Wound Journal, 12, 523-526. https://doi.org/10.1111/iwj.12146
[11]
Honda, Y., Hirano, K., Yamawaki, M., et al. (2017) Wound Healing of Critical Limb Ischemia with Tissue Loss in Patients on Hemodialysis. Vascular, 25, 272-282. https://doi.org/10.1177/1708538116673015
[12]
Dugbartey, G.J. and Alornyo, K.K. (2022) Association between Diabetic Kidney Disease and Diabetic Foot Ulceration. In: Raghav, A., Ed., Diabetic Foot—Recent Advances, IntechOpen, London. https://doi.org/10.5772/intechopen.107825
[13]
He, Y., Qian, H., Xu, L., et al. (2017) Association between Estimated Glomerular Filtration Rate and Outcomes in Patients with Diabetic Foot Ulcers: A 3-Year Follow-Up Study. European Journal of Endocrinology, 177, 41-50. https://doi.org/10.1530/EJE-17-0070
Huang, Y.Y., Lin, C.W., Cheng, N.C., et al. (2021) Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients with Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Network Open, 4, e2122607. https://doi.org/10.1001/jamanetworkopen.2021.22607
[16]
Krediet, R.T. and Parikova, A. (2022) Relative Contributions of Pseudohypoxia and Inflammation to Peritoneal Alterations with Long-Term Peritoneal Dialysis Patients. Clinical Journal of the American Society of Nephrology, 17, 1259-1266. https://doi.org/10.2215/CJN.15371121
[17]
Nassar, G.M. (2013) Preventing and Treating Inflammation: Role of Dialysis Access Management. Seminars in Dialysis, 26, 28-30. https://doi.org/10.1111/sdi.12023
[18]
Velloso, M.S., Otoni, A., de Paula Sabino, A., et al. (2014) Peritoneal Dialysis and Inflammation. Clinica Chimica Acta, 430, 109-114. https://doi.org/10.1016/j.cca.2013.12.003
[19]
Maroz, N. and Simman, R. (2013) Wound Healing in Patients with Impaired Kidney Function. Journal of the American College of Clinical Wound Specialists, 5, 2-7. https://doi.org/10.1016/j.jccw.2014.05.002
[20]
Klinger, M. and Madziarska, K. (2019) Mortality Predictor Pattern in Hemodialysis and Peritoneal Dialysis in Diabetic Patients. Advances in Clinical and Experimental Medicine, 28, 133-135. https://doi.org/10.17219/acem/76751
