Abstract
The aim of this prospective cross-sectional study was to reveal clinical characteristics of Japanese diabetic patients with chronic limb-threatening ischemia (CLTI) presenting ischemic unhealed ulcer/gangrene (Fontaine stage IV) in the real-world settings. The present study included 132 Japanese diabetic patients who underwent endovascular therapy for CLTI presenting Fontaine stage IV. The prevalence of diabetes-related complications, as well as prior history of ankle-brachial index (ABI) measurement before CLTI onset, was evaluated adopting multiple imputation (50 times). Duration of diabetes was referred to as time from diagnosis. The patients were aged 70 ± 10 years, with duration of diabetes 23 ± 12 years. The diabetes-related complications were so common that only 17% (95% confidence interval: 11–24%) and 25% (17–33%) of the population were free from advanced micro- and macroangiopathies, respectively. The clustering of advanced macroangiopathies was not significantly associated with duration of diabetes (P = 0.62). On the other hand, that of advanced microangiopathies was significantly positively associated with duration of diabetes (P = 0.004). However, even in patients with duration of diabetes < 10 years, as many as 63% (38–87%) of patients had at least one advanced microangiopathy. Only 31% (22–39%) of the patients had prior history of ABI measurement before CLTI onset. The history was inversely associated with age (P = 0.005). In conclusion, the advanced diabetes-related complications were highly prevalent, even in those whose diabetes was diagnosed less than a decade before. In addition, only a few patients had ever undergone ABI measurement before CLTI onset.
Similar content being viewed by others
References
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33(Suppl 1):S1–75.
Iida O, Takahara M, Soga Y, Kodama A, Terashi H, Azuma N. Three-year outcomes of surgical versus endovascular revascularization for critical limb ischemia: the SPINACH study (surgical reconstruction versus peripheral intervention in patients with critical limb ischemia). Circ Cardiovasc Interv. 2017;10(12):e005531.
Haneda M, Noda M, Origasa H, Noto H, Yabe D, Fujita Y, et al. japanese clinical practice guideline for diabetes 2016. Diabetol Int. 2018;9:1–45.
Takahara M, Iida O, Fujita Y, Haneda M. Clinical characteristics of Japanese diabetic patients with critical limb ischemia presenting Fontaine stage IV. Diabetol Int. 2018. https://doi.org/10.1007/s13340-018-0387-6.
Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart association Task Force on clinical practice guidelines. J Am Coll Cardiol. 2017;69:e71–126.
Shimamoto K, Ando K, Fujita T, Hasebe N, Higaki J, Horiuchi M, et al. The Japanese Society of hypertension guidelines for the management of hypertension (JSH 2014). Hypertens Res. 2014;37:253–390.
Teramoto T, Sasaki J, Ishibashi S, Birou S, Daida H, Dohi S, et al. Executive summary of the Japan Atherosclerosis Society (JAS) guidelines for the diagnosis and prevention of atherosclerotic cardiovascular diseases in Japan -2012 version. J Atheroscler Thromb. 2013;20:517–23.
Haneda M, Utsunomiya K, Koya D, Babazono T, Moriya T, Makino H, et al. A new classification of Diabetic Nephropathy 2014: a report from Joint Committee on Diabetic Nephropathy. J Diabetes Investig. 2015;6:242–6.
Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, et al. Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care. 2008;31:1679–85.
Sone H, Katagiri A, Ishibashi S, Abe R, Saito Y, Murase T, et al. Effects of lifestyle modifications on patients with type 2 diabetes: the Japan Diabetes Complications Study (JDCS) study design, baseline analysis and three year-interim report. Horm Metab Res. 2002;34:509–15.
Yokoyama H, Oishi M, Takamura H, Yamasaki K, Shirabe SI, Uchida D, et al. Large-scale survey of rates of achieving targets for blood glucose, blood pressure, and lipids and prevalence of complications in type 2 diabetes (JDDM 40). BMJ Open Diabetes Res Care. 2016;4:e000294.
Hayashino Y, Izumi K, Okamura S, Nishimura R, Origasa H, Tajima N. Duration of diabetes and types of diabetes therapy in Japanese patients with type 2 diabetes: the Japan Diabetes Complication and its Prevention prospective study 3 (JDCP study 3). J Diabetes Investig. 2017;8:243–9.
Ueki K, Sasako T, Kato M, Okazaki Y, Okahata S, Katsuyama H, et al. Design of and rationale for the Japan Diabetes Optimal Integrated Treatment study for 3 major risk factors of cardiovascular diseases (J-DOIT3): a multicenter, open-label, randomized, parallel-group trial. BMJ Open Diabetes Res Care. 2016;4:e000123.
Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, et al. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018;39:763–816.
Uccioli L, Gandini R, Giurato L, Fabiano S, Pampana E, Spallone V, et al. Long-term outcomes of diabetic patients with critical limb ischemia followed in a tertiary referral diabetic foot clinic. Diabetes Care. 2010;33:977–82.
Lejay A, Georg Y, Tartaglia E, Gaertner S, Geny B, Thaveau F, et al. Long-term outcomes of direct and indirect below-the-knee open revascularization based on the angiosome concept in diabetic patients with critical limb ischemia. Ann Vasc Surg. 2014;28:983–9.
Freisinger E, Malyar NM, Reinecke H, Lawall H. Impact of diabetes on outcome in critical limb ischemia with tissue loss: a large-scaled routine data analysis. Cardiovasc Diabetol. 2017;16:41.
Noronen K, Saarinen E, Alback A, Venermo M. Analysis of the elective treatment process for critical limb ischaemia with tissue loss: diabetic patients require rapid revascularisation. Eur J Vasc Endovasc Surg. 2017;53:206–13.
Meloni M, Izzo V, Giurato L, Del Giudice C, Da Ros V, Cervelli V, et al. Recurrence of critical limb ischemia after endovascular intervention in patients with diabetic foot ulcers. Adv Wound Care (New Rochelle). 2018;7:171–6.
Faglia E, Dalla Paola L, Clerici G, Clerissi J, Graziani L, Fusaro M, et al. Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003. Eur J Vasc Endovasc Surg. 2005;29:620–7.
Fujishima M, Kiyohara Y, Kato I, Ohmura T, Iwamoto H, Nakayama K, et al. Diabetes and cardiovascular disease in a prospective population survey in Japan: the Hisayama Study. Diabetes. 1996;45(Suppl 3):S14–6.
Nakagami T. Hyperglycaemia and mortality from all causes and from cardiovascular disease in five populations of Asian origin. Diabetologia. 2004;47:385–94.
Kuzuya T, Akanuma Y, Akazawa Y, Uehata T. Prevalence of chronic complications in Japanese diabetic patients. Diabetes Res Clin Pract. 1994;24(Suppl):S159–64.
Kuwashiro T, Sugimori H, Ago T, Kuroda J, Kamouchi M, Kitazono T. The impact of predisposing factors on long-term outcome after stroke in diabetic patients: the Fukuoka Stroke Registry. Eur J Neurol. 2013;20:921–7.
Kawasaki S, Misawa H, Tamura Y, Kondo Y, Satoh S, Hasegawa O, et al. Relationship between coronary artery disease and retinopathy in patients with type 2 diabetes mellitus. Intern Med. 2013;52:2483–7.
Tsuboi S, Miyauchi K, Kasai T, Ogita M, Dohi T, Miyazaki T, et al. Impact of red blood cell distribution width on long-term mortality in diabetic patients after percutaneous coronary intervention. Circ J. 2013;77:456–61.
Acknowledgements
This study was supported by a Grant-in-Aid (Nos. 201709007A and 201608012A) for Scientific Research from the Ministry of Health, Labour and Welfare of Japan.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflicts of interests associated with this manuscript.
Human rights statement
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later revision.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
About this article
Cite this article
Takahara, M., Okuno, S., Nakamura, I. et al. Prospective study on clinical characteristics of Japanese diabetic patients with chronic limb-threatening ischemia presenting Fontaine stage IV. Diabetol Int 11, 33–40 (2020). https://doi.org/10.1007/s13340-019-00399-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s13340-019-00399-5