RESUMEN
Few diseases globally require treatment from so many different disciplines as diabetes-related foot disease. At least 25 different professionals may be involved: casting technicians, dermatologists, diabetes (educator) nurses, diabetologists, dieticians, endocrinologists, general practitioners, human movement scientists, infectious diseases experts, microbiologists, nuclear medicine physicians, orthopaedic surgeons, orthotists, pedorthists, physical therapists, plastic surgeons, podiatric surgeons, podiatrists, prosthetists, psychologists, radiologists, social workers, tissue viability physicians, vascular surgeons, and wound care nurses. A shared vocabulary and shared treatment goals and recommendations are then essential. The International Working Group on the Diabetic Foot (IWGDF) has produced guidelines and supporting documents to stimulate and support shared and multidisciplinary evidence-based treatment in diabetes-related foot disease. In this special virtual issue of Diabetes/Metabolism Research and Reviews, all 21 documents of the 2023 update of the IWGDF Guidelines are bundled, added with a further 6 reviews from multidisciplinary experts to drive future research and clinical innovations, based on their contributions to the International Symposium on the Diabetic Foot. We hope the readers will enjoy this special virtual issue, and widely implement the knowledge shared here in their daily clinical practice and research endeavours with the goal to improve the care for people with diabetes-related foot disease.
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Diabetes Mellitus , Pie Diabético , Enfermedades del Pie , Médicos , Humanos , Pie Diabético/etiología , Pie Diabético/terapia , Endocrinólogos , Diabetes Mellitus/terapiaRESUMEN
OBJECTIVE: To estimate whether the topical, amino acid-buffered hypochlorite debriding gel ChloraSolv (RLS Global AB, Sweden) could potentially afford the UK's health services a cost-effective intervention for hard-to-heal venous leg ulcers (VLUs). METHOD: A Markov model representing the management of hard-to-heal VLUs with ChloraSolv plus standard care (SC) or SC alone was populated with inputs from an indirect comparison of two propensity score-matched cohorts. The model estimated the relative cost-effectiveness of ChloraSolv in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2021/2022 prices. RESULTS: Addition of ChloraSolv to an SC protocol was found to increase the probability of healing by 36% (from 0.14 to 0.19) after 12 weeks, and by 79% (from 0.24 to 0.43) after 24 weeks. This led to a marginal increase in health-related quality of life. Treatment with ChloraSolv plus SC instead of SC alone reduced the total cost of wound management by 8% (£189 per VLU) at 12 weeks and by 18% (£796 per VLU) at 24 weeks. Use of ChloraSolv was estimated to improve health outcomes at reduced cost. Sensitivity analysis showed that use of ChloraSolv plus SC remained a cost-effective treatment with plausible variations in costs and effectiveness. CONCLUSION: Within the limitations of the study, the addition of ChloraSolv to an SC protocol potentially affords a cost-effective treatment to the UK's health services for managing hard-to-heal VLUs.
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Calidad de Vida , Úlcera Varicosa , Humanos , Análisis Costo-Beneficio , Úlcera Varicosa/tratamiento farmacológico , Cicatrización de Heridas , Costos de la Atención en SaludRESUMEN
AIMS: Diabetes-related foot disease is a major source of patient burden and societal costs. Investing in evidence-based international guidelines on diabetes-related foot disease is important to reduce this burden and costs, provided the guidelines are focused on outcomes important to key stakeholders and are evidence-based and properly implemented. MATERIALS AND METHODS: The International Working Group on the Diabetic Foot (IWGDF) has published and updated international guidelines since 1999. The 2023 updates were made using the Grading of Recommendations Assessment Development and Evaluation evidence-to-decision framework. This concerns formulating relevant clinical questions and important outcomes, conducting systematic reviews of the literature and meta-analyses where appropriate, completing summary of judgement tables, and writing recommendations that are specific, unambiguous and actionable, along with their transparent rationale. RESULTS: We herein describe the development of the 2023 IWGDF Guidelines on the prevention and management of diabetes-related foot disease, which consists of seven chapters, each prepared by a separate working group of international experts. These chapters provide guidelines related to diabetes-related foot disease on prevention; classification of diabetes-related foot ulcer, offloading, peripheral artery disease, infection, wound healing interventions, and active Charcot neuro-osteoarthropathy. Based on these seven guidelines, the IWGDF Editorial Board also produced a set of practical guidelines. Each guideline underwent extensive review by the members of the IWGDF Editorial Board as well as independent international experts in each field. CONCLUSIONS: We believe that the adoption and implementation of the 2023 IWGDF guidelines by healthcare providers, public health agencies, and policymakers will improve the prevention and management of diabetes-related foot disease, and subsequently reduce the worldwide patient and societal burden caused by this disease.
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Pie Diabético , Enfermedades del Pie , Enfermedad Arterial Periférica , Humanos , Pie Diabético/etiología , Pie Diabético/prevención & control , Cicatrización de Heridas , Agencias InternacionalesRESUMEN
Foot disease is a devastating complication of diabetes. For almost 3 decades, the mission of the International Working Group on the Diabetic Foot (IWGDF) is to produce evidence-based guidelines to inform health care providers worldwide on strategies for the prevention and management of diabetes-related foot disease. In this publication, we aim to better inform the reader about 'the story behind' the IWGDF Guidelines and thus facilitate improved uptake of the recommendations described in the guidelines. The first IWGDF Guidelines were published in 1999, and these have been successfully updated every 4 years since. With each update, IWGDF has improved the methodological rigour and extended the topics covered. This has been possible thanks to the involvement of > 100 experts from > 60 countries, all voluntarily dedicating their time. We estimate that the 2023 update of the IWGDF Guidelines required a total 10 years of full-time work, which would have cost 2 million euros if the voluntary work had been financially compensated. The IWGDF Guidelines are not only published in English but also translated to support local implementation. Currently available translations serve 2.9 billion people globally in their native language. As an independent and multidisciplinary organisation, IWGDF hopes that the 2023 update will continue to stimulate clinicians from all different disciplines to deliver the best care possible for these patients, will motivate researchers to undertake the high-quality trials needed to deliver the new evidence to advance the field further, and collectively will support people with diabetes-related foot disease to minimize their disease burdens.
RESUMEN
Diabetes-related foot disease results in a major global burden for patients and the healthcare system. The International Working Group on the Diabetic Foot (IWGDF) has been producing evidence-based guidelines on the prevention and management of diabetes-related foot disease since 1999. In 2023, all IWGDF Guidelines have been updated based on systematic reviews of the literature and formulation of recommendations by multidisciplinary experts from all over the world. In addition, a new guideline on acute Charcot neuro-osteoarthropathy was created. In this document, the IWGDF Practical Guidelines, we describe the basic principles of prevention, classification and management of diabetes-related foot disease based on the seven IWGDF Guidelines. We also describe the organisational levels to successfully prevent and treat diabetes-related foot disease according to these principles and provide addenda to assist with foot screening. The information in these practical guidelines is aimed at the global community of healthcare professionals who are involved in the care of persons with diabetes. Many studies around the world support our belief that implementing these prevention and management principles is associated with a decrease in the frequency of diabetes-related lower-extremity amputations. The burden of foot disease and amputations is increasing at a rapid rate, and comparatively more so in middle to lower income countries. These guidelines also assist in defining standards of prevention and care in these countries. In conclusion, we hope that these updated practical guidelines continue to serve as a reference document to aid healthcare providers in reducing the global burden of diabetes-related foot disease.
Asunto(s)
Diabetes Mellitus , Pie Diabético , Enfermedades del Pie , Humanos , Pie Diabético/etiología , Pie Diabético/prevención & control , Agencias Internacionales , Amputación Quirúrgica , Diabetes Mellitus/prevención & controlRESUMEN
Multiple disciplines are involved in the management of diabetes-related foot disease and a common vocabulary is essential for clear communication. Based on the systematic reviews of the literature that form the basis of the International Working Group on the Diabetic Foot (IWGDF) Guidelines, the IWGDF has developed a set of definitions and criteria for diabetes-related foot disease. This document describes the 2023 update of these definitions and criteria. We suggest these definitions be used consistently in both clinical practice and research, to facilitate clear communication with people with diabetes-related foot disease and between professionals around the world.
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Diabetes Mellitus , Pie Diabético , Enfermedades del Pie , Humanos , Pie Diabético/diagnóstico , Pie Diabético/etiologíaRESUMEN
Objective: To compare the number of ulcer-free days during 24 months in persons with diabetes and a healed foot ulcer below the ankle provided with adjusted therapeutic shoes who were given standard information and participated in participant-driven group education compared with standard information alone. Methods: A randomized controlled trial was designed to evaluate the number of ulcer-free days after participant-driven group education in addition to standard information compared with standard information alone. The number needed to treat (N = 174) was not met, as only 138 persons with diabetes and previously healed foot ulcer were recruited (age median 63 years [34-79], 101 men/37 women). Results: A total of 138 persons were recruited, of whom 107 (77.5%) completed the study, 7 (5%) dropped out, and 12 (9%) deceased. No statistically significant difference was found between the intervention group compared with the control group after 6, 18, or 24 months. After 12 months, more patients in the intervention group had developed ulcers. Seventy-seven participants (56%) developed new foot ulcers, irrespective of side and site. Development of one ulcer appeared in 36 participants, two ulcers in 19, and 22 participants developed three ulcers. Forty-eight participants remained ulcer-free (35%) during the 24-month follow-up. Median ulcer-free days until first ulceration were 368 (4-720); until second ulceration, 404 (206-631); and until third ulceration, 660 (505-701). The participants wore prescribed therapeutic shoes during 88% of the follow-up visits. Conclusions: One-third of the participants remained ulcer-free for 24 months. Patient-driven education in groups did not give better results than standard information in this underpowered study. This study illustrates the challenges to perform comparative preventive studies in this group of patients with extensive comorbidity. Further studies are needed to evaluate interventions on ulceration in persons with a healed foot ulcer.
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Diabetes Mellitus , Pie Diabético , Úlcera del Pie , Masculino , Humanos , Femenino , Persona de Mediana Edad , Pie Diabético/terapia , Cicatrización de Heridas , Úlcera del Pie/terapia , PieRESUMEN
AIM: The aim of this study was to explore the temporal development of beliefs about health, illness and health care in migrant women with gestational diabetes (GD) born in Asia residing in Sweden, and the influence on health-related behaviour in terms of self-care and seeking care. BACKGROUND: Migrant Asian women are a high-risk group for developing GD. Adapting to the culture in the new society and the healthcare system, being diagnosed with GD and becoming a mother is demanding. The question is whether Asian migrants' patterns of beliefs and behaviour change over time, as no previous study has been revealed on this topic. METHOD: Qualitative prospective exploratory study. Semi-structured interviews were held on three occasions: during pregnancy and three and fourteen months after delivery, with women born in Asia, diagnosed with GD. Data were analysed with qualitative content analysis. FINDINGS: There was a temporal change of beliefs influencing health-related behaviour, showing a rising curve in risk awareness. An increasing number of persons described developing a healthy diet/lifestyle based on initial advice and shifted focus from the child to worries about the woman's health and risk of developing type 2 diabetes and being unable to care for the child/family. Also, the number of women perceiving GD as a transient condition decreased and more believed it would last forever. Beliefs about health care were unchanged, the healthcare model was perceived working well but information about GD and follow-ups was requested even after delivery, and competent staff was expected. Health professionals' beliefs about the seriousness of GD influence patients' beliefs and need to be considered. Migrant women need support with adequate information, based on their individual beliefs, to continue develop a sustainable healthy lifestyle even after giving birth, to promote health and prevent type 2 diabetes.
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Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Migrantes , Niño , Femenino , Promoción de la Salud , Humanos , Embarazo , Estudios Prospectivos , Investigación Cualitativa , SueciaRESUMEN
PurposeRepetitive iodinated contrast media exposure may be harmful for the kidneys. The aim of the present study was to evaluate if patients with diabetes mellitus (DM) undergoing CT angiography (CTA) and local continuous thrombolysis for acute lower limb ischemia (ALI) had an increased risk of developing contrast-associated acute kidney injury (CA-AKI) compared to patients without DM. Methods: This is a retrospective study of patients undergoing CTA and local continuous thrombolysis due to ALI between 2001 and 2018. CA-AKI was defined as a 25% increase in serum creatinine within 72 hours after latest contrast administration. Results: There was no difference (P = .30) in the frequency of CA-AKI between patients with (27.9%; n = 43) and without DM (20.6%; n = 170). Among patients with CA-AKI, patients with DM had a lower (P < .001) estimated glomerular filtration rate (eGFR) at discharge (55 ml/min/1.73 m2) than at admission (70 ml/min/1.73 m2), while no such difference was found in the group without DM (P = .20). The gram-iodine dose/eGFR ratio was higher (P < .001) in patients with CA-AKI (median 1.49, [IQR 1.34-1.81]) than in those who did not develop CA-AKI (median 1.05 [IQR 1.00-1.13]). There was a trend that gram-iodine dose/eGFR ratio (OR 1.42/standard deviation increment, 95% CI 1.00-2.02; P = .050) was associated with an increased risk of CA-AKI, after adjusting for DM, age, and gender. Conclusions: The frequency of CA-AKI was high after CTA and local continuous thrombolysis for ALI without shown increased frequency for the DM group. Among patients with CA-AKI, however, patients with DM had worse renal function at discharge than those without DM. The gram-iodine dose/eGFR ratio in these patients needs to be lower to improve renal outcomes, particularly in patients with DM.
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Lesión Renal Aguda , Diabetes Mellitus , Lesión Renal Aguda/inducido químicamente , Lesión Renal Aguda/diagnóstico por imagen , Angiografía por Tomografía Computarizada , Medios de Contraste/efectos adversos , Tasa de Filtración Glomerular , Humanos , Isquemia/diagnóstico por imagen , Estudios Retrospectivos , Factores de Riesgo , Terapia Trombolítica/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: Patients with diabetes mellitus (DM) have a more extensive distal arterial occlusive disease compared to non-diabetic patients. Diagnostic imaging is a necessity to identify the location and extent of the arterial occlusion in acute limb ischemia (ALI). Computed tomography angiography (CTA) is the most commonly used modality and the diagnostic performance with CTA of calf arteries may be questioned. PURPOSE: To evaluate diagnostic performance of CTA of calf arteries in ALI and to compare patients with and without DM. MATERIAL AND METHODS: All thrombolytic treatments performed during 2001-2018 in patients with ALI were included. Initial digital subtraction angiography (DSA) and CTA of all patients were classified according to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) below-the-knee arteries and compared to CTA. Two raters assessed the CTA images independently. Inter-rater reliability was expressed as intraclass correlation (ICC) with 95% confidence intervals (CI). RESULTS: Patients with (n = 23) and without (n = 85) DM had lower (P = 0.006) glomerular filtration rate. ICC between CTA and DSA was 0.33 (95% CI -0.22 to 0.56) and 0.71 (95% CI 0.38-0.68) in patients with and without DM, respectively. Sensitivity with CTA for TASC D lesions in patients with and without DM was 0.14 (95% CI -0.12 to 0.40) and 0.64 (95% CI 0.48-0.80), respectively. CONCLUSION: The sensitivity of CTA for assessment of infra-popliteal TASC D lesions in patients with ALI was not acceptable in patients with DM in contrast to those without DM. Another imaging option at present times should be considered for patients with DM.
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Arteriopatías Oclusivas , Diabetes Mellitus , Enfermedad Arterial Periférica , Angiografía de Substracción Digital , Angiografía por Tomografía Computarizada , Humanos , Isquemia/diagnóstico por imagen , Enfermedad Arterial Periférica/diagnóstico por imagen , Arteria Poplítea , Reproducibilidad de los Resultados , Sensibilidad y EspecificidadRESUMEN
Many patients with venous leg ulcers do not reach complete healing with compression treatment alone, which is current standard care. This clinical trial HEAL LL-37 was a phase IIb double-blind, randomized, placebo-controlled study, with the aim to evaluate the efficacy and safety of a new drug LL-37 for topical administration, in combination with compression therapy, in 148 patients suffering from hard-to-heal venous leg ulcers. The study had three arms, consisting of two groups treated with LL-37 at concentrations of 0.5 or 1.6 mg/mL, and a placebo cohort. Patients had a mean age of 67.6 years, a median ulcer duration of 20.3 months, and a mean wound size at the time of randomization of 11.6 cm2 . Efficacy analysis performed on the full study population did not identify any significant improvement in healing in patients treated with LL-37 as compared with the placebo. In contrast, a post hoc analysis revealed statistically significant improvement with LL-37 treatment in several interrelated healing parameters in the subgroup of patients with large target wounds (a wound area of at least 10 cm2 at randomization), which is a known negative prognostic factor for healing. The study drug was well tolerated and safe in both dose strengths. In summary, this clinical trial did not detect any significant differences in healing of venous lower leg ulcers in the entire study cohort comparing patients treated with LL-37 versus placebo. A subgroup analysis provided an interesting observation that LL-37 could offer a treatment benefit in patients with large ulcers, exigently warranting a further study adequately powered to statistically assess the treatment outcome in this patient group.
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Úlcera de la Pierna , Úlcera Varicosa , Anciano , Método Doble Ciego , Humanos , Úlcera de la Pierna/tratamiento farmacológico , Estudios Prospectivos , Resultado del Tratamiento , Úlcera Varicosa/tratamiento farmacológico , Cicatrización de HeridasRESUMEN
BACKGROUND: Forefoot gangrene in patients with diabetes is a severe form of foot ulcers with risk of progress and major amputation. No large cohort studies have examined clinical characteristics and outcome of forefoot gangrene in patients with diabetes. The aim was to examine clinical characteristics and outcome of forefoot gangrene in patients with diabetes admitted to a diabetic foot centre. METHODS: Patients with diabetes and foot ulcer consecutively presenting were included if they had forefoot gangrene (Wagner grade 4) at initial visit or developed forefoot gangrene during follow-up at diabetic foot centre. Patients were prospectively followed up until final outcome, either healing or death. The median follow-up period until healing was 41 (3-234) weeks. RESULTS: Four hundred and seventy-six patients were included. The median age was 73 (35-95) years and 63% were males. Of the patients, 82% had cardiovascular disease and 16% had diabetic nephropathy. Vascular intervention was performed in 64%. Fifty-one patients (17% of surviving patients) healed after auto-amputation, 150 after minor amputation (48% of surviving patients), 103 had major amputation (33% of surviving patients) and 162 patients deceased unhealed. Ten patients were lost at follow-up. The median time to healing for all surviving patients was 41 (3-234) weeks; for auto-amputated, 48 (10-228) weeks; for minor amputated, 48 (6-234) weeks; and for major amputation, 32 (3-116) weeks. CONCLUSION: Healing without major amputation is possible in a large proportion of patients with diabetes and forefoot gangrene, despite these patients being elderly and with extensive co-morbidity.
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OBJECTIVE: Wounds such as lower extremity ulcers are serious, costly and frequently hard to heal. Guidelines conclude that new dressings and treatments generally fail to show superiority compared with standard of care. Several mechanisms are probably responsible for impaired healing of hard-to-heal wounds, including inflammation and infection. Amino acid-buffered hypochlorite has presumed antiseptic and antibacterial properties and has been shown to be useful in the treatment of diabetic foot ulcers (DFUs). We evaluated the debriding effect of amino acid-buffered hypochlorite (ChloraSolv) on full skin hard-to-heal lower extremity ulcers covered with devitalised tissue (≥50%), with six applications over 5 weeks and follow-up at 12 weeks. METHOD: This was an open-label, single-arm, multicentre, pre-market pilot investigation. We recruited subjects with a lower extremity ulcer, covered with devitalised tissue (≥50%), who were candidates for cleansing and debridement/desloughing. There was a weekly application of the investigational device for five weeks. Follow-up for wound status evaluation was performed at 12 weeks from baseline. RESULTS: We evaluated 57 subjects (33 males, 24 females, median age 73 years, range 51-90 years) (intention-to-treat). Of these, 61.4% had a leg ulcer and 38.6% a foot ulcer. The median wound size at baseline was 7.7cm2 (range 2.1-52cm2) with devitalised tissue coverage of 76.5%. After 5 weeks, a decrease of 72.7% in devitalised tissue was seen, and 71.4% of the subjects showed a decrease in devitalised tissue of ≥50% (evaluated independently using PictZar). At 12 weeks' follow-up the decrease in devitalised tissue was 84.4%. Wound-related pain was reported by ten subjects, resulting in 17 adverse events (AEs). Among these, 12 AEs from eight subjects were recorded as possibly or probably related to the investigational device and one AE was reported to have a causal relationship with the investigational device. CONCLUSION: This clinical study suggests that amino acid-buffered hypochlorite can be effective and well tolerated in the treatment of hard-to-heal lower extremity ulcers to dissolve and remove devitalised tissue.
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Aminoácidos/uso terapéutico , Pie Diabético/terapia , Ácido Hipocloroso/uso terapéutico , Úlcera de la Pierna/terapia , Cicatrización de Heridas/efectos de los fármacos , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Resultado del TratamientoRESUMEN
AIM: No previous studies have been found focusing on the long-term development of beliefs about health, illness and healthcare in migrant women with gestational diabetes mellitus (GDM). The aim of this study was to explore this and the influence on health-related behaviour (i.e. self-care and care seeking) in migrant women from the Middle East living in Sweden seven years after delivery. BACKGROUND: GDM is increasing, particularly in migrant women. The risk of adverse outcomes of GDM for health can be improved by interventions reducing blood glucose and lifestyle modifications which medicalise the woman's pregnancy due to intensive follow-up and demanding self-care. The reactions might have an enduring impact on the women's long-term psychological and physical health and adoption of preventive health behaviours. METHOD: Qualitative exploratory study. Semi-structured follow-up interviews 7 years after delivery with women previously interviewed in gestational weeks 34-38 and 3 and 14 months after delivery. Data analysed with qualitative content analysis. FINDINGS: Health meant freedom from illness, feeling well and living long to be able to care for the children. The present situation was described either positively, changing to a healthier lifestyle, or negatively, with worries about being affected by type 2 diabetes. Beliefs changed among the majority of women, leading to a healthier lifestyle, and they looked positively back at the time when diagnosed and their reactions to it. With few exceptions, they were confident of being aware of future health risks and felt responsible for their own and their children's health/lifestyle. None except those diagnosed with type 2 diabetes had been in contact with healthcare since the last follow-up a year after delivery. Yet, they still would like and need a healthcare model delivering more information, particularly on developing a healthy lifestyle for children, and with regular check-ups also after the first year after delivery.
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Diabetes Gestacional , Migrantes , Diabetes Mellitus Tipo 2/terapia , Femenino , Estudios de Seguimiento , Humanos , Medio Oriente , Embarazo , SueciaRESUMEN
BACKGROUND: Limited scientific evidence for prevention and treatment of diabetic foot ulcers in elderly with comorbidities. AIM: To explore patient-related factors and outcomes in patients ≥75 years with diabetes and a foot ulcer. METHOD: Sub-analysis of consecutively presenting patients ≥75 years (N = 1008) from a previous study on 2,480 patients with diabetic foot ulcer treated in a multidisciplinary system until healing. Patient characteristics: age - 81(75-96); diabetes type 2-98.7%; male/female - 49/51%; living with a spouse - 47%; nursing home 16%; or with home nursing 64%. RESULT: Primary healing was achieved in 54%, minor amputation 8%, major amputation 9%, auto-amputation 2%, and 26% of the patients died unhealed. Among the oldest (88-96 years), 31% healed without any amputation. Extensive comorbidities were frequent: neuropathy 93%, visual impairment 73%, cardiovascular disease 60%, cerebrovascular disease 34%, and severe peripheral disease in 29% of the patients. Out of patients (80%) living in institutions or dependent on home nursing, 56% healed without amputation, compared to 44% of patients living in their own home without any support from social services or home nursing. CONCLUSION: Healing without major amputation was achieved in 84% of surviving patients ≥75 years, despite extensive comorbidity and dependency.
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Amputación Quirúrgica/estadística & datos numéricos , Diabetes Mellitus Tipo 2/complicaciones , Pie Diabético/terapia , Cicatrización de Heridas , Factores de Edad , Anciano , Anciano de 80 o más Años , Comorbilidad , Pie Diabético/patología , Femenino , Humanos , Masculino , Probabilidad , Características de la Residencia/estadística & datos numéricos , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
In patients with diabetes, foot ulceration and peripheral artery disease (PAD), it is often difficult to determine whether, when and how to revascularise the affected lower extremity. The presence of PAD is a major risk factor for non-healing and yet clinical outcomes of revascularisation are not necessarily related to technical success. The International Working Group of the Diabetic Foot updated systematic review on the effectiveness of revascularisation of the ulcerated foot in patients with diabetes and PAD is comprised of 64 studies describing >13 000 patients. Amongst 60 case series and 4 non-randomised controlled studies, we summarised clinically relevant outcomes and found them to be broadly similar between patients treated with open vs endovascular therapy. Following endovascular revascularisation, the 1 year and 2 year limb salvage rates were 80% (IQR 78-82%) and 78% (IQR 75-83%), whereas open therapy was associated with rates of 85% (IQR 80-90%) at 1 year and 87% (IQR 85-88%) at 2 years, however these results were based on a varying combination of studies and cannot therefore be interpreted as cumulative. Overall, wound healing was achieved in a median of 60% of patients (IQR 50-69%) at 1 year in those treated by endovascular or surgical therapy, and the major amputation rate of endovascular vs open therapy was 2% vs 5% at 30 days, 10% vs 9% at 1 year and 13% vs 9% at 2 years. For both strategies, overall mortality was found to be high, with 2% (1-6%) perioperative (or 30 day) mortality, rising sharply to 13% (9-23%) at 1 year, 29% (19-48%) at 2 years and 47% (39-71%) at 5 years. Both the angiosome concept (revascularisation directly to the area of tissue loss via its main feeding artery) or indirect revascularisation through collaterals, appear to be equally effective strategies for restoring perfusion. Overall, the available data do not allow us to recommend one method of revascularisation over the other and more studies are required to determine the best revascularisation approach in diabetic foot ulceration.
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Diabetes Mellitus/fisiopatología , Pie Diabético/terapia , Procedimientos Endovasculares/métodos , Pie/irrigación sanguínea , Pie/cirugía , Enfermedad Arterial Periférica/complicaciones , Pie Diabético/etiología , HumanosRESUMEN
Clinical outcomes of patients with diabetes, foot ulceration, and peripheral artery disease (PAD) are difficult to predict. The prediction of important clinical outcomes, such as wound healing and major amputation, would be a valuable tool to help guide management and target interventions for limb salvage. Despite the existence of a number of classification tools, no consensus exists as to the most useful bedside tests with which to predict outcome. We here present an updated systematic review from the International Working Group of the Diabetic Foot, comprising 15 studies published between 1980 and 2018 describing almost 6800 patients with diabetes and foot ulceration. Clinical examination findings as well as six non-invasive bedside tests were evaluated for their ability to predict wound healing and amputation. The most useful tests to inform on the probability of healing were skin perfusion pressure ≥ 40 mmHg, toe pressure ≥ 30 mmHg, or TcPO2 ≥ 25 mmHg. With these thresholds, all of these tests increased the probability of healing by greater than 25% in at least one study. To predict major amputation, the most useful tests were ankle pressure < 50 mmHg, ABI < 0.5, toe pressure < 30 mmHg, and TcPO2 < 25 mmHg, which increased the probability of major amputation by greater than 25%. These indicative values may be used as a guide when deciding which patients are at highest risk for poor outcomes and should therefore be evaluated for revascularization at an early stage. However, this should always be considered within the wider context of important co-existing factors such as infection, wound characteristics, and other comorbidities.
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Amputación Quirúrgica/métodos , Biomarcadores/análisis , Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 2/complicaciones , Pie Diabético/diagnóstico , Procedimientos Endovasculares/métodos , Cicatrización de Heridas , Pie Diabético/etiología , Pie Diabético/terapia , Humanos , Pronóstico , Terapias en InvestigaciónRESUMEN
Diabetic foot disease results in a major global burden for patients and the health care system. The International Working Group on the Diabetic Foot (IWGDF) has been producing evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. In 2019, all IWGDF Guidelines have been updated based on systematic reviews of the literature and formulation of recommendations by multidisciplinary experts from all over the world. In this document, the IWGDF Practical Guidelines, we describe the basic principles of prevention, classification, and treatment of diabetic foot disease, based on the six IWGDF Guideline chapters. We also describe the organizational levels to successfully prevent and treat diabetic foot disease according to these principles and provide addenda to assist with foot screening. The information in these practical guidelines is aimed at the global community of health care professionals who are involved in the care of persons with diabetes. Many studies around the world support our belief that implementing these prevention and management principles is associated with a decrease in the frequency of diabetes-related lower extremity amputations. We hope that these updated practical guidelines continue to serve as reference document to aid health care providers in reducing the global burden of diabetic foot disease.