Homogenized and Lyophilized Amniotic Membrane Dressings for the Treatment of Diabetic Foot Ulcers in Ambulatory Patients.

BACKGROUND: Diabetic foot ulcers (DFUs) constitute a complication that occurs in 19% to 34% of patients with diabetes mellitus (DM). The aim of this study is to describe median days to healing, average velocity of wound closure, and percentage of wound surface closed at 3, 6, and 12 weeks through the use of homogenized and lyophilized amniotic membrane (hAMpe) dressings for the treatment of DFUs in ambulatory patients. METHODS: An observational, descriptive, longitudinal study was performed. Patients presenting with granulation-based DFU, after proper debridement, were included from August 19, 2021, until July 14, 2023. hAMpe dressings placed every 3 days were used for the treatment of these ulcers. RESULTS: Sixteen patients were included with a mean age of 52.38 (8.07) years. The analyzed lesions were postsurgical ulcers in 15 of the 16 included patients. Median ulcer size was 19.5 cm2 (6.12-36). The median ABI was 1.10 (1-1.14). The median days to healing was 96 (71-170). The median percentage closure of the wound at 3 weeks was 41% (28.9%-55.3%), at 6 weeks it was 68.2% (48.6%-74.2%), and at 12 weeks it was 100% (81%-100%). The average velocity closure was 1.04% per day (95% CI 0.71%-1.31%). It was higher during the closure of the first 50% of the ulcer, 2.12% per day (95% CI 0.16%-4.09%), and decreased from 50% to 25% of the ulcer size to 0.67% per day (95% CI 0.23%-1.10%) and from 25% to closure to 0.47% per day (95% CI 0.14%-0.80%), P < .001. CONCLUSION: These results are difficult to compare to other studies given the higher surface area of the ulcers included in our sample. The development of hAMpe dressings enables patients to apply them without requiring assistance from health care teams and was not associated with any recognized complications. LEVEL OF EVIDENCE: Level IV, case series.

Plantar Thermography in High-Risk Patients With Diabetes Mellitus Compared to Nondiabetic Individuals.

Diabetic foot (DF) is one of the most devastating complications of diabetes mellitus (DM). Infrared thermography has been studied for its potential in early diagnosis and preventive measures against DF ulcers, although its role in the management and prevention of DF complications remains uncertain. The objective of this study was to determine the average temperatures of different points of the plantar foot using infrared thermography in patients with DM and history of DF (DFa group, at the highest risk of developing foot ulcers) and compare them to people without DM (NoDM group). One hundred and twenty-three feet were included, 63 of them belonged to DFa Group and the other 60 to NoDM Group. The average temperature in the NoDM Group was 27.4 (26.3-28.5) versus 28.6 (26.8-30.3) in the DFa Group (p = .002). There were differences between both groups in temperatures at the metatarsal heads and heels, but not in the arch. Average foot temperatures did not relate to sex, ankle-brachial index, and age, and had a mild correlation with daily temperature (Spearman 0.51, p < .001). Data provided in our study could be useful in establishing a parameter of normal temperatures for high-risk patients. This could serve as a foundational framework for future research and provide reference values, not only for preventative purposes, as commonly addressed in most studies, but also to assess the applicability of thermography in clinical scenarios particularly when one foot cannot serve as a reference, suspected osteomyelitis of the remaining bone, or instances of increased temperature in specific areas which may necessitate adjustments to the insoles in secondary prevention.

Validación de clasificaciones de pie diabético en Argentina / Validation of diabetic foot classifications in Argentina

Introducción: las clasificaciones de pie diabético (PD) son una herramienta que tienen el objetivo de mejorar la comunicación entre los profesionales, la referencia y contrarreferencia; proporcionar un pronóstico; ayudar en la valoración de las lesiones, y contribuir con fines estadísticos. Objetivos: describir las características de los pacientes que se presentaron al consultorio o a la guardia con un PD durante un período de 3 meses, determinar el riesgo según cinco clasificaciones (Texas, IDSA, San Elián, WIfI y SINBAD) y evaluar su evolución a 6 meses en relación con el grado de gravedad determinada por cada clasificación. Materiales y métodos: se analizaron 312 pacientes de 15 instituciones en Argentina. Para el análisis se utilizó la calculadora de clasificaciones de pie diabético/score de riesgo del Comité de Pie Diabético de la Sociedad Argentina de Diabetes. Resultados: el 43% de los pacientes (n=133) requirió internación al momento de la primera consulta y el 61% (n=189) había consultado previamente. El porcentaje de amputación mayor total fue de 8,33% (IC 95%; 5,5-11,9) (n=26) y el de amputación menor de 29,17% (IC 95%; 24,2-34,6) (n=91). A los 6 meses, el porcentaje de muerte fue de 4,49% (IC 95%; 2,5-7,4) (n=14), el 24,3% (IC 95%;19,6-29,5) presentaba la herida aún abierta (n=76), el 58,0% (IC 95%; 52,3-66,5) (n=181) cicatrizó y el 7,37% se perdió del seguimiento (n=23). Las clasificaciones de San Elián y WIfI se relacionaron con amputación mayor, cicatrización y muerte. En relación a la clasificación de Texas, el 49% de los pacientes presentó herida penetrante a hueso o articulación (Texas 3), con o sin infección. El 65,3% de las amputaciones mayores y el 78,6% de las muertes se produjeron en pacientes con isquemia. El punto de corte de San Elián para amputación mayor fue 20. Conclusiones: conocer los datos locales permite organizar los recursos para mejorar la atención de los pacientes.

Introduction: the classifications of diabetic foot (DF) are a tool that aims to improve communication between professionals, referral and counter-referral, provide a prognosis, help in the assessment of lesions, and contribute to statistical purposes. Objectives: to describe the characteristics of patients who presented to the clinic or emergency department with DF over a period of 3 months, determine the risk according to 5 classifications (Texas, IDSA, SEWSS, WIfI, and SINBAD), and evaluate their evolution at 6 months in relation to the severity degree determined by each classification. Materials and methods: 312 patients from 15 institutions in Argentina were analyzed. The Diabetic Foot Classification Calculator/Risk Score from the Diabetic Foot Committee of the Argentina Argentina Diabetes Society was used for the analysis. Results: 43% of patients (n=133) required hospitalization at the time of the first consultation and 61% (n=189) had previously consulted. The total major amputation percentage was 8.33% (95%CI; 5.5-11.9) (n=26), and the minor amputation percentage was 29.17% (95% CI; 24.2-34.6) (n=91). At 6 months, the death rate was 4.49% (95% CI; 2.5-7.4) (n=14), 24.3% (95% CI; 19.629.5) had an open wound (n=76), 58.0% (95% CI; 52.3-66.5) (n=181) had healed, and 7.37% were lost to follow-up (n=23). The SEWSS and WIfI classifications were related to major amputation, healing, and death. Regarding the Texas classification, 49% of patients had a penetrating wound to bone or joint (Texas 3), with or without infection. 65.3% of major amputations and 78.6% of deaths occurred in patients with ischemia. The SEWSS cut-off point for major amputation was 20. Conclusions: knowing local data allows organizing resources to improve patient care.

Diabetic Foot Osteomyelitis: Is it all the Same?

Diabetic foot osteomyelitis (OM) requires a longer duration of therapy, a greater need for surgery and implies a higher rate of recidivism, a higher amputation risk, and lower treatment success. But do all bone infections behave the same way, require the same treatment, or imply the same prognosis? Actually, in clinical practice we can verify there are different clinical presentations of OM. The first one is that associated with the infected diabetic foot attack. It requires urgent surgery and debridement since "time is tissue." Clinical features and radiographs are enough for the diagnosis, and treatment should not be delayed. The second one is related to a sausage toe. It affects phalanges and it can be treated with a 6- or 8-week antibiotic course with a high rate of success. Clinical features and radiographs are sufficient for the diagnosis in this case. The third presentation is OM superimposed to Charcot's neuroarthropathy, which mainly comprises midfoot or hindfoot. It starts with a plantar ulcer in a foot that has developed a deformity. The treatment is based on an accurate diagnosis that often includes magnetic resonance, and requires a complex surgery to preserve the midfoot and to avoid recurrent ulcers or foot instability. The final presentation is that of an OM without large soft tissue compromise secondary to a chronic ulcer or a previous unsuccessful surgery secondary to minor amputation or debridement. There is often a small ulcer with a positive probe to bone test over a bony prominence. Diagnosis is made by clinical features, radiographs, and laboratory tests. Treatment includes antibiotic therapy guided by surgical or transcutaneous biopsy, but this presentation often requires surgery. Different presentations of OM mentioned above need to be recognized because the diagnosis, type of culture, antibiotic treatment, surgical treatment, and prognosis are different upon the presentation.

Recomendaciones de práctica clínica: diagnóstico de osteomielitis en pie diabético / Clinical practice recommendations for the diagnosis of osteomyelitis in the diabetic foot

La osteomielitis (OM) es una complicación de las úlceras en pie diabético que habitualmente es subdiagnosticada y tratada en forma tardía e inadecuada. La demora en el tratamiento de estos pacientes aumenta el riesgo de amputación. En esta revisión, se analiza la bibliografía actual acerca del diagnóstico de OM y se realizan recomendaciones en base a la misma, y a las características de los pacientes, los insumos y las posibilidades en nuestro medio.

Diabetic foot osteomyelitis (OM) is a diabetic foot ulcer complication. Usually, it is misdiagnosed and the treatment is delayed and inadequate. Delaying the treatment of these patients rises the risk of amputation. In this revision, current bibliography about this topic is updated and clinical practice recommendations are done, based on the publications and adapted to the characteristics of our country

Recomendaciones de práctica clínica: diagnóstico de osteomielitis en pie diabético / Clinical practice recommendations for the diagnosis of osteomyelitis in the diabetic foot

Resumen La osteomielitis (OM) es una complicación de las úlceras en pie diabético que habitualmente es subdiagnosticada y tratada en forma tardía e inadecuada. La demora en el tratamiento de estos pacientes aumenta el riesgo de amputación. En esta revisión, se analiza la bibliografía actual acerca del diagnóstico de OM y se realizan recomendaciones en base a la misma, y a las características de los pacientes, los insumos y las posibilidades en nuestro medio.

Abstract Diabetic foot osteomyelitis (OM) is a diabetic foot ulcer complication. Usually, it is misdiagnosed and the treatment is delayed and inadequate. Delaying the treatment of these patients rises the risk of amputation. In this revision, current bibliography about this topic is updated and clinical practice recommendations are done, based on the publications and adapted to the characteristics of our country.

Diabetic Foot Infections: Bacterial Isolates From the Centers and Hospitals of Latin American Countries.

Diabetic foot infections (DFIs) are one of the most important reasons for lower limb amputations. An adequate approach to the management of DFI implies control of infection using strategies of tissue debridement and empirical antibiotic treatment based on local microbiology. The aim of this study was to determine the bacterial isolates profile and antibiotic susceptibility patterns in samples from DFI from Latin American centers, on the premise that microbiology of this region differs from that of other continents and influences antimicrobial election. Three hundred and eighty-two samples from soft tissue and bone were studied from 17 centers of 4 countries. Three hundred and seven (80.4%; 95% confidence interval = 75.9-84.2) were positive. Gram negatives (GN) were isolated in 43.8% of all samples, not only in severe but also in mild infections, 51% in bone samples, more frequently in presence of ischemia (47% vs 38%; P = .07) and in wounds with longer duration of the lesion (30-20 days; P < .01). Staphylococcus aureus was the most frequent single germ (19.9%). Gram positives were isolated more frequently in patients without ischemia (53% vs 40%; P = .01). Enterococcus faecalis was the most frequent germ in bone samples (16.8%). Ciprofloxacin and trimethoprim-sulfamethoxazole were the oral antimicrobials most effective against GN. Trimethoprim-sulfamethoxazole and rifampicin were the oral antimicrobials most effective against Staphylococcus. Because of GN high antibiotic resistance patterns, patients treated in an ambulatory setting have to be controlled early after starting empiric treatment to assess response to therapy and hospitalize for parenteral antibiotics if oral treatment fails.

A Comparison Between Diabetic Foot Classifications WIfI, Saint Elian, and Texas: Description of Wounds and Clinical Outcomes.

Several wound classification systems are used to assess diabetic foot wounds. The recommendations for their use depend on the authors and foot associations. In this study, we compared Saint Elian score system, WIfI classification and Texas in 101 patients with foot wounds, and we followed them for a median of 149 days, finding differences both in the assigned risk and in the association with major amputation and wound healing. Saint Elian and WIfI scores match when Saint Elian is low or high risk but not when it is moderate. WIfI stages correlate with major amputation and wound healing. Saint Elian III correlates with major amputation. Prevalence of major amputations was 41% for WIfI 4 and 83% for Saint Elian III. WIfI 1 and 2 and Saint Elian I had a rate of wound healing of 80% to 85%. Stages 1 and 2 of WIfI score behave similar with regard to wound healing, 82% and 80% (P = .71), and major amputation, 0% and 10% (P = .68). Stages I and II of Saint Elian have the same rates of major amputation, 0% and 8% (P = .66), but not of wound healing, 85% and 51% (P < .05). The optimal cut point for detecting major amputation in Saint Elian is 18, with a sensitivity of 90.9 and specificity of 84.9, but there is no recommended cut point for wound healing. These classifications are validated for their use in diabetic foot wounds and to assess amputation risk, helping physicians make decisions and talk to the patients about prognosis.

Differential Diagnosis of Charcot Neuroarthropathy in Subacute and Chronic Phases: Unusual Diseases.

Charcot Neuroarthropaty (CN) is a complication of diabetes with devastating consequences as it produces severe deformities in the foot developing in recurrent ulcers that rise the probability of amputation. There are several diseases mentioned in the literature that have to be considered for the differential diagnosis of CN, often related to the acute phase (gout, ankle sprain, inflammatory arthritis, cellulitis, venous thrombosis) but there is paucity of information related to the differential diagnosis in later stages (coalescence, remodeling) when there is deformity of the foot. Clinicians and diabetologists are not familiarized with orthopedic pathology and do not have in mind certain diseases that could mimic CN in the subacute or chronic phases and this can develop in a wrong diagnosis. It is important to make a correct diagnosis in patients with suspected CN not only in the acute phase but also in the chronic phase to establish an accurate treatment. This article is a review of the differential diagnosis of CN in subacute and chronic phases showing similarities and differences that can help clinicians and diabetologists to make an accurate diagnosis and treatment. We describe unusual diseases like tendon and muscles disorders, Frieberg's disease, complex pain regional syndrome, transient regional osteoporosis and osteomyelitis superimposed to CN and the main features of each one that could help in making a differential diagnosis.

Estudio de factores de riesgo para el desarrollo de pie diabético: Campaña 1N / A study of risk factors in the development of diabetic foot: 1N Campaign

Introducción: el examen del pie es fundamental en pacientes con diabetes mellitus (DM). La correcta evaluación del pie en el paciente que concurre a control diabetológico es clave para establecer factores de riesgo para el desarrollo de úlceras, detectar lesiones, tomar medidas preventivas, realizar una derivación temprana y educar en cuidados del pie. Objetivos: en este estudio se examinaron los pies de personas con DM durante la Campaña de Concientización y Prevención del Pie Diabético el 1º de noviembre de 2019 con el fin de evaluar la presencia de síntomas y signos relacionados con neuropatía, enfermedad vascular periférica, y prevalencia de los mismos, y conocer el riesgo. Materiales y métodos: se analizaron 165 pacientes en cuatro centros: Sanatorio Güemes (Servicio de Diabetes y Endocrinología), PREDIGMA (Centro de Medicina Preventiva, Posadas, Misiones), Hospital Central de San Isidro, Nexo Centro Médico (Ciudad de Junín) y Hospital Municipal de General Viamonte (Provincia de Buenos Aires). Resultados: se encontró que el 43,6% presentaba algún síntoma en miembros inferiores y hasta el 57% alteración en las pruebas de tamizaje de neuropatía diabética o enfermedad arterial periférica, con mayor prevalencia a mayor tiempo de evolución de la DM. Los signos más frecuentemente hallados en el examen físico fueron: piel seca (71,5%), distrofia ungueal (60,6%) o alteración de la almohadilla plantar (52,1%). Las comorbilidades más frecuentes fueron: hipertensión (74,5%) y dislipemia (73,3%). La mediana de hemoglobina glicosilada fue de 7,40% (6,70-8,10), mayor en personas con antecedentes de retinopatía (7,8%; p<0,01) y en pacientes que refirieron tener calambres (7,85 a 7,30; p=0,03) o ardor (8,0 vs 7,3; p<0,01). El porcentaje de pacientes con pie de alto riesgo por antecedentes, inspección o tamizaje de neuropatía o enfermedad vascular representó desde el 40% en aquellos con DM de menos de cinco años de evolución hasta el 86% en quienes tenían más de 20 años. Conclusiones: el elevado porcentaje de pacientes con pie de riesgo identificado en este estudio sugiere que, además del correcto examen físico, se requiere la toma de conductas por parte del médico tratante, como la indicación de plantillas o calzado adecuado, así como una fluida derivación al técnico en ortesis, traumatólogo o fisiatra.

Introduction: foot examination is essential in patients with diabetes mellitus (DM). The correct evaluation of the foot in the patient who attends diabetes control is key to establish risk factors for the development of ulcers, detect injuries, take preventive measures, make an early referral and educate in foot care. Objectives: in this study, the feet of people with DM were examined during the Diabetic Foot Awareness and Prevention Campaign on November 1, 2019 in order to assess the presence of symptoms and signs related to neuropathy, peripheral vascular disease, prevalence of the same and know the risk. Materials and methods: 165 patients were analyzed in four centers: Sanatorio Güemes (Diabetes and Endocrinology Service), PREDIGMA (Preventive Medicine Center, Posadas, Misiones), Central Hospital of San Isidro, Nexo Medical Center (Junín City) and Hospital Municipal of General Viamonte (Province of Buenos Aires). Results: it was found that 43.6% had some symptoms in the lower limbs and up to 57% had an alteration in the screening tests for diabetic neuropathy or peripheral arterial disease, with a higher prevalence the longer the evolution of DM. The most frequent signs found in the physical examination were: dry skin (71.5%), nail dystrophy (60.6%) or alteration of the foot pad (52.1%). The lost frequent comorbidities were: hypertension (74.5%) and dyslipidemia (73.3%). The median glycated hemoglobin was 7.40% (6.70-8.10), higher in people with a history of retinopathy (7.8%; p <0.01) and in patients who reported having cramps (7, 85 to 7.30; p = 0.03) or burning (8.0 vs 7.3; p <0.01). The percentage of patients with high-risk foot due to antecedents, inspection or screening for neuropathy or vascular disease represented from 40% in those with DM of less than five years of evolution to 86% in those who were older than 20 years. Conclusions: this high percentage of patients with foot at risk identified in this study suggests that, in addition to the correct physical examination, the attending physician requires the taking of behaviors, such as the indication of appropriate footwear or insoles, as well as a fluid referral to the orthotic technician, orthopedic surgeon, or physiatrist.