Two-Step Conservative Surgery for Complicated Forms of Diabetes-Related Foot Osteomyelitis.

Diabetes-related foot osteomyelitis (DFO) is a common yet complex condition, often complicated by concurrent soft tissue infections (STIs). This study evaluates the efficacy of a two-step conservative surgical approach, hypothesizing that it offers comparable outcomes to a one-step procedure. Conducted on a cohort of 93 patients with DFO, the study categorized cases into two types: OM1 (osteomyelitis without STI) and OM2 (osteomyelitis with STI). OM2 was further subdivided into OM2a (early diagnosis) and OM2b (late diagnosis), with OM2 patients undergoing initial soft tissue debridement followed by elective bone surgery. The results indicated no significant differences in infection recurrence or amputation rates between the two surgical approaches, with recurrence observed in 20.7% of cases and amputations in 10.8%. The two-step procedure was associated with higher inflammatory responses and greater need for antibiotics and hospital admissions. However, these factors did not translate into increased recurrence or amputation compared to the one-step procedure. The study supports the two-step approach as a safe and effective method for managing complicated DFO cases, providing a viable alternative to immediate amputation or single-stage surgery. Despite some limitations, including regional specificity and potential underdiagnosis in late-diagnosed cases, the findings offer valuable insights for clinical management and suggest further research to refine treatment protocols. The study's strengths include confirmed histopathological diagnoses and consistent follow-up, reinforcing the validity of the two-step surgical approach for complex DFO treatment.

Outpatient Foot-Sparing Surgery Is Safe in Selected Patients with Diabetic Foot Infections.

OBJECTIVE: To determine if outpatient foot-sparing surgery for patients with diabetic foot infections (DFIs) is associated with a higher rate of treatment failure or longer healing time. METHODS: In this prospective observational study, the authors consecutively recruited a cohort of 200 patients with moderate and severe DFIs from the Diabetic Foot Unit of Hospital San Juan de Dios, Caja Costarricense de Seguro Social, San José de Costa Rica, Costa Rica from October 15, 2020 to December 15, 2021. They compared outpatients with those admitted. Cox univariate analysis was performed, with time to treatment failure and time to healing as dependent variables and outpatient management as the independent variable. RESULTS: Seventy-one patients underwent surgery on an outpatient basis (35.5%), and 129 (64.5%) were admitted. Sixty of 111 patients (54.1%) with moderate infections were treated as outpatients versus 11 of 89 (12.4%) of those with severe infections. Twelve (16.9%) of the outpatients and 26 (20.2%) of those admitted presented failure (P = .57). The Cox univariate analysis with time to failure of treatment associated with outpatient management reported a hazard ratio of 1.26 (95% CI, 0.64-2.50; P = .50), and the analysis regarding healing time reported a hazard ratio of 0.91 (95% CI, 0.66-1.25; P = .56). CONCLUSIONS: Foot-sparing surgery on an outpatient basis was safe in more than half the cases of moderate DFIs, especially in patients with osteomyelitis. This approach is not associated with treatment failure or a longer healing time. Patients with severe infections, penetrating injuries, necrosis, or high inflammatory response and those with peripheral arterial disease who require revascularizations should be admitted to the hospital.

Diagnosis of infection in the foot of patients with diabetes: A systematic review.

BACKGROUND: Securing an early accurate diagnosis of diabetic foot infections and assessment of their severity are of paramount importance since these infections can cause great morbidity and potential mortality and present formidable challenges in surgical and antimicrobial treatment. METHODS: In June 2022, we searched the literature using PubMed and EMBASE for published studies on the diagnosis of diabetic foot infection (DFI). On the basis of pre-determined criteria, we reviewed prospective controlled, as well as non-controlled, studies in English. We then developed evidence statements based on the included papers. RESULTS: We selected a total of 64 papers that met our inclusion criteria. The certainty of the majority of the evidence statements was low because of the weak methodology of nearly all of the studies. The available data suggest that diagnosing diabetic foot infections on the basis of clinical signs and symptoms and classified according to the International Working Group of the Diabetic Foot/Infectious Diseases Society of America scheme correlates with the patient's likelihood of the need for hospitalisation, lower extremity amputation, and risk of death. Elevated levels of selected serum inflammatory markers such as erythrocyte sedimentation rate (ESR), C-reactive protein and procalcitonin are supportive, but not diagnostic, of soft tissue infection. Culturing tissue samples of soft tissues or bone, when care is taken to avoid contamination, provides more accurate microbiological information than culturing superficial (swab) samples. Although non-culture techniques, especially next-generation sequencing, are likely to identify more bacteria from tissue samples including bone than standard cultures, no studies have established a significant impact on the management of patients with DFIs. In patients with suspected diabetic foot osteomyelitis, the combination of a positive probe-to-bone test and elevated ESR supports this diagnosis. Plain X-ray remains the first-line imaging examination when there is suspicion of diabetic foot osteomyelitis (DFO), but advanced imaging methods including magnetic resonance imaging (MRI) and nuclear imaging when MRI is not feasible help in cases when either the diagnosis or the localisation of infection is uncertain. Intra-operative or non-per-wound percutaneous biopsy is the best method to accurately identify bone pathogens in case of a suspicion of a DFO. Bedside percutaneous biopsies are effective and safe and are an option to obtain bone culture data when conventional (i.e. surgical or radiological) procedures are not feasible. CONCLUSIONS: The results of this systematic review of the diagnosis of diabetic foot infections provide some guidance for clinicians, but there is still a need for more prospective controlled studies of high quality.

Risk Factors Associated with Failure of Toe Amputation in Diabetic Foot Infections.

We aim to identify the factors associated with the failure of amputation of one to three toes (index toe amputation) in patients with diabetes and foot infection. We conducted a retrospective cohort of 175 patients with diabetes who were hospitalized for moderate to severe foot infection and underwent amputation of one to three toes. A Poisson regression model was used to determine the prevalence ratio (PR) as a measure of association. The mean age was 63.3 ± 11.4 years. Fifty-three patients presented failure after undergoing toe amputation (30.3%). Multivariate analysis, adjusted for age and sex, showed the following significant variables: severe infection (PR: 1.78; 95% confidence interval [CI]: 1.14-2.78; P = 0.011), infection by Escherichia coli (PR: 2.21; 95% CI: 1.42-3.43; P < 0.001), infection by Pseudomonas aeruginosa (PR: 2.11; 95% CI: 1.29-3.43; P = 0.003) and prothrombin time (PR: 1.13; 95% CI: 1.05-1.21; P = 0.001), obesity (PR: 0.58; 95% CI: 0.37-0.93; P = 0.024), and haemoglobin value (PR: 0.92; 95% CI: 0.86-0.99; P = 0.023). About one-third of patients who underwent amputation of one to three toes for diabetic foot infection presented a failure and required a more proximal surgery. Severe infections, isolation of Pseudomonas aeruginosa and Escherichia coli, and prolonged prothrombin time were associated with a higher prevalence of failure. However, obesity and an elevated haemoglobin level were associated with a lower prevalence of failure.

Residual osteomyelitis at the resection margin after conservative surgery is not associated with the recurrence of diabetic foot infection and may successfully be treated without postoperative antibiotic therapy.

AIMS: We hypothesize that microbiology- and pathology-confirmed positive bone margins after the resection of diabetes-related foot osteomyelitis are associated with worse outcomes. METHODS: We conducted a prospective study consisting of a cohort of 93 patients with diabetes-related foot osteomyelitis (histopathology confirmed) who underwent bone resection and where an additional bone biopsy was taken at the resection margin. The primary outcome was the recurrence of the infection. RESULTS: Pathology-confirmed positive margins were detected in 62 cases (66.7%), microbiology-confirmed positive margins were detected in 75 cases (80.6%) and recurrence was detected in 19 patients (20.4%). Chi-squared test failed to show the presence of an association between the recurrence of the infection with pathology-confirmed positive margins (p = 0.82), with microbiology-confirmed positive margins, (p = 0.34) and with the use of postoperative antibiotics (p = 0.70). Healing in patients with pathology-confirmed positive margins was achieved in a median of 12 weeks (95% CI 9.2-18) and those with pathology-confirmed negative margins in 14.9 weeks (95% CI 10.2-21.9), Log-rank test, p = 0.74. Thirty-four patients out of 61 available for follow-up (55.7%) with pathology-confirmed positive margins were treated without postoperative antibiotics. In that group, Chi-squared test failed to show the presence of an association between the recurrence of the infection with the use of postoperative antibiotics (p = 0.47). CONCLUSIONS: A positive margin was neither associated with the recurrence of the infection nor with the time to healing. More than half of patients with pathology-confirmed positive margins were treated without postoperative antibiotics and this approach was not associated with the recurrence of the infection.

Conservative Surgery for Diabetic Foot Osteomyelitis is not Associated With Longer Survival Time Without Recurrence of Foot Ulcer When Compared With Amputation.

Conservative surgery of diabetic foot osteomyelitis (DFO) in which bone infection is removed without amputation could minimize the biomechanical changes associated with foot surgery. We hypothesize that patients who undergo conservative surgery will have a longer survival time without recurrence of foot ulcers and further amputations than those who undergo any type of amputation to treat DFO. We assessed a retrospective cohort of 108 patients who underwent surgery for DFO from January 2011 to December 2012. Patients were followed-up until May 2020. Reulceration and reamputation-free survival times were plotted using the Kaplan-Meier method and were calculated from the date of first surgery to recurrence, new amputation, or end of the study. A stratified log rank was used to study differences among groups. Cumulative survival without recurrences at 1, 5, and 8 years was 95%, 36%, and 29%, respectively, in patients who underwent conservative surgery and 95%, 43%, and 30%, respectively, in those undergoing amputation. Cumulative survival without a new amputation at 1, 5, and 8 years was 100%, 80%, and 80%, respectively, in patients who underwent conservative surgery and 98%, 82%, and 69%, respectively, in those undergoing amputation. No differences were found regarding either recurrence (log rank, P = .98) or new amputations (log rank, P = .64). In conclusion, conservative surgery is as safe as amputation to arrest bone infection in the feet of patients with diabetes. Conservative surgery was not associated with a lower rate of recurrence and new amputations than those patients who underwent amputations.

Long-term Mortality of a Cohort of Patients Undergoing Surgical Treatment for Diabetic Foot Infections. An 8-year Follow-up Study.

We analyzed a retrospective cohort of 150 patients with diabetic foot infections (DFIs) who underwent surgical treatment to determine long-term outcomes. The median follow-up of the series was 7.6 years. Cox's proportional hazards model for survival time was performed and hazard ratios (HRs) were estimated. Survival times were plotted using the Kaplan-Meier method. Fifteen patients (10%) required readmission after discharge from the hospital for a recurrence of the infection. Ninety patients (60%) had re-ulcerations. Forty-nine (54.4% of those re-ulcerated) required new admission and 24 of them (26.6% of those re-ulcerated) finally required a new amputation. Overall cumulative survival rates at 1, 5, and 8 years were 95%, 78%, and 64%, respectively. Predictive variables of long-term mortality were insulin treatment (HR: 2.0, 95% CI: 1.1-3.6, P = .01), female sex (HR: 3.1, 95% CI: 1.7-5.3, P<.01) and estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2 (HR: 2.2, 95% CI: 1.1-4.2, P = .01). In conclusion, patients undergoing surgical treatment for DFIs had a high rate of recurrences and mortality. Women, patients who underwent treatment with insulin, and those with eGFR <60 ml/min/1.73 m2 had a higher risk of long-term mortality.

Does Metabolic Control Have Any Influence on the Clinical Presentation and Short-Term Outcomes of Diabetic Foot Infections?

Objective: We hypothesized that patients with poor glycemic control undergoing treatment for diabetic foot infections (DFIs) would have a poorer prognosis than those with better metabolic control assessed by glycated hemoglobin (HbA1c). Approach: We analyzed a retrospective cohort of 245 patients with moderate and severe DFIs. HbA1c values were dichotomized (<7% or ≥7% and ≤75th percentile (P75) and >P75) to analyze patient outcomes regarding metabolic control. The present study adhered to the STROBE guidelines for cohort studies. Results: One hundred sixty-nine patients (69%) were men. Their mean age was 60.7 years (10.8). HbA1c ≥7% was detected in 203 patients (82.9%). P75 HbA1c was 10.9%. After performing univariate analysis, we found an association of HbA1c <7% with major amputations and mortality. However, after applying the logistic regression model, we did not find HbA1c <7% to be a predictive factor of major amputation. The risk factors for mortality following application of Cox's proportional hazards model were osteomyelitis (HR: 0.2, 95% CI: 0.07-0.62, p < 0.01), eGFR <60 mL/min/1.73 m2 (HR: 2.7, 95% CI: 1.0-7.5, p = 0.04), and HbA1c <7% (HR: 4.9, 95% CI: 1.8-13.2, p < 0.01). Innovation: The group with optimal glycemic control (HbA1c <7%) had a shorter survival time than those with worse metabolic control. Conclusions: We did not find a longer duration of hospitalization, a higher rate of amputations, or longer healing times in the groups with worse metabolic control. HbA1c <7% was a risk factor for mid-term mortality.

Surgical Diabetic Foot Infections: Is Osteomyelitis Associated With a Worse Prognosis?

It has been reported that patients with diabetes and foot ulcers complicated with osteomyelitis (OM) have a worse prognosis than those complicated with soft tissue infections (STI). Our study aimed to determine whether OM is associated with a worse prognosis in cases of moderate and severe diabetic foot infections requiring surgery. A retrospective series consisted of 150 patients who underwent surgery for diabetic foot infections. We studied the differences between OM versus STI. Furthermore, diabetic foot infections were reclassified into four groups: moderate STI (M-STI), moderate OM (M-OM), severe STI (S-STI), and severe OM (S-OM). The variables associated with prognosis were limb loss, length of hospital stay, duration of antibiotic treatment, recurrence of the infection, and time to healing (both the initial ulcer and the postoperative wound). No differences in limb salvage, hospital stay, duration of antibiotic treatment, recurrence of the infection, and time to healing were found when comparing OM with STI. Patients with M-O had a higher rate of recurrences after initial treatment and a longer time to healing when comparing with M-STI. We didn't find any differences between severe infections with or without OM. In conclusion, we have found in our surgical series of diabetic foot infections that OM is not associated with worse prognosis when comparing with STI regarding limb loss rate, length of hospital stays, duration of antibiotic treatment, recurrence of the infection, and time to healing. The results of the present series should further be confirmed by other authors.

Surgery without postoperative antibiotic treatment in diabetic foot osteomyelitis is not associated with recurrence or limb loss.

Not using antibiotics after surgical treatment of diabetic foot osteomyelitis was not associated with failure of the surgery, recurrences, or limb loss. Antibiotics were given in doubtful complicated cases such as severe infections, cases with necrosis, foul-smelling lesions and patients requiring revascularization.

Prospective Validation of the Value of Adding Osteomyelitis to Moderate and Severe Categories of Diabetic Foot Infections.

We aimed to validate the value of adding osteomyelitis (OM) to moderate and severe categories of diabetic foot infections (DFIs) classification. We conducted a prospective study of a cohort of 200 patients with moderate and severe infections. Variables associated with prognosis were need for any amputation, major amputation, need for hospitalization, length of hospitalization, length of antibiotic therapy, reinfection rate and infection-related mortality. Infections were moderate in 111 cases (55.5%) and severe in 89 (44.5%). OM was diagnosed in 114 cases (57%), 73 presented as moderate (36.5%) and 41 as severe (20.5%). Overall, 129 patients (64.5%) were admitted for a median of 15 days (IQR 13) and 71 (35.5%) were treated as outpatients (day-surgery). Ninety-four patients (47%) were exclusively treated with intravenous antibiotics, 35 (17.5%) with intravenous and then shifting to oral, 16 (8%) exclusively with oral antibiotics, and 55 (27.5%) without antibiotics. Definitive surgery that led to the arrest of the infection was as follows: 117 patients (58.5%) underwent surgical debridement without amputation, and 69 (34.5%) underwent minor and 14 (7%) major amputation. Patients with OM presented as severe had a higher rate of amputations, major amputations, hospitalizations and need for antibiotic therapy when compared with OM presented as moderate. OM is strongly recommended to be added to the moderate and severe categories of the Infectious Diseases Society of America/International Working Group on Diabetic Foot severity system, as recommended by the International Working Group on Diabetic Foot 2019 guidelines.

Controversial Issues Regarding Positive Bone Margins in Surgery for Diabetic Foot Osteomyelitis: A Pilot Study.

Obtaining clean margins in patients who undergo surgical treatment for diabetic foot osteomyelitis (DFO) is recommended. We hypothesize that the rate of recurrence of the infection is not associated with positive margins, even when using a short-term duration of postoperative antibiotic treatment. We conducted a retrospective pilot study of patients who underwent surgery for DFO confirmed by histopathological analysis of the resected bone from August 1, 2020, to December 1, 2020. Bone samples were taken from the proximal margins to be studied by microbiology and histopathology. Twenty-five (89.3%) patients underwent conservative surgery, and 3 (10.7%) patients underwent a minor amputation. After surgery, the antibiotics were stopped in 19 (67.9%) patients and continued in 9 (32.1%) patients for a median period of 4 days. The microbiology of the bone margins was positive in 20 (71.4%) cases, but the histopathology of the bone margins was positive in just 7 (25%) cases. Recurrence of the infection was detected in 3 (10.7%) patients. Seventeen (68%) patients with microbiological-positive margins did not have a recurrence of infection, while 3 (100%) patients had a recurrence of infection (P = .53). Six (24%) patients among those with histopathological-positive margins did not have a recurrence of infection, and1 (33.3%) patient had a recurrence of infection (P = 1). The recurrence of infection was low and always detected in soft tissues, including the cases with a histopathological-positive bone margin. Postoperative antibiotics were administered for a short period of time and not based on the analysis of bone margins.

Clinical, microbiological and inflammatory markers of severe diabetic foot infections.

AIMS: In addition to systemic inflammatory response syndrome (SIRS), various clinical signs, microbiological findings and inflammatory markers could be associated with severe diabetic foot infections (DFI). METHODS: This study included a retrospective cohort of 245 patients with DFI treated at San Juan de Dios Hospital in San José de Costa Rica. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), CRP/albumin ratio, peripheral blood leucocyte ratios and the Laboratory Risk Indicator for Necrotizing Fasciitis (LRINEC) scoring system were evaluated. Univariate analysis was carried out between moderate and severe infections. ROC curves were plotted. Cut-off value of inflammatory markers for diagnosing severe infections was established and then dichotomized to be included in a logistic regression model. A score was designed based on its results. RESULTS: Skin necrosis (p < 0.01, OR = 8.5, 95% CI = 3.5-20.9), ESR > 94 mm/h (p < 0.01, OR = 2.5, 95% CI = 1.2-5.1), albumin < 2.8 g/dl (p = 0.04, OR = 2.0, 95% CI = 1.0-4.1) and neutrophil-to-lymphocyte ratio (NLR) > 4.52 (p < 0.01, OR = 3.3, 95% CI = 1.6-6.5) were found to be predictive of severe infections. Score >5 had a good diagnosis performance for classifying severe infections. Moderate infections with a score >5 had a worse prognosis than moderate ones. CONCLUSIONS: We found an association of necrosis, serum albumin, ESR and NLR values with severe DFI. The presence of these predictive factors of severity in cases of moderate infections was significantly associated with a higher rate of amputations and recurrences, longer duration of antibiotic treatment and longer hospital stays. DFI could be classified as mild, moderate, severe without SIRS and severe.

Interventions in the management of infection in the foot in diabetes: a systematic review.

The optimal approaches to managing diabetic foot infections remain a challenge for clinicians. Despite an exponential rise in publications investigating different treatment strategies, the various agents studied generally produce comparable results, and high-quality data are scarce. In this systematic review, we searched the medical literature using the PubMed and Embase databases for published studies on the treatment of diabetic foot infections as of June 2018. This systematic review is an update of previous reviews, the first of which was undertaken in 2010 and the most recent in 2014, by the infection committee of the International Working Group of the Diabetic Foot. We defined the context of literature by formulating clinical questions of interest, then developing structured clinical questions (PICOs) to address these. We only included data from controlled studies of an intervention to prevent or cure a diabetic foot infection. Two independent reviewers selected articles for inclusion and then assessed their relevant outcomes and the methodological quality. Our literature search identified a total of 15 327 articles, of which we selected 48 for full-text review; we added five more studies discovered by means other than the systematic literature search. Among these selected articles were 11 high-quality studies published in the last 4 years and two Cochrane systematic reviews. Overall, the outcomes in patients treated with the different antibiotic regimens for both skin and soft tissue infection and osteomyelitis of the diabetic foot were broadly equivalent across studies, except that treatment with tigecycline was inferior to ertapenem (±vancomycin). Similar outcomes were also reported in studies comparing primarily surgical and predominantly antibiotic treatment strategies in selected patients with diabetic foot osteomyelitis. There is insufficient high-quality evidence to assess the effect of various adjunctive therapies, such as negative pressure wound therapy, topical ointments or hyperbaric oxygen, on infection related outcomes of the diabetic foot. In general, the quality of more recent trial designs are better in past years, but there is still a great need for further well-designed trials to produce higher quality evidence to underpin our recommendations.

Perioperative and long-term all-cause mortality in patients with diabetes who underwent a lower extremity amputation.

INTRODUCTION: Long-term mortality of patients with diabetes who undergo lower extremity amputation (LEA) has not been reported in Spain. METHODS: The retrospective cohort included all subjects who underwent LEAs from January 1, 2005 to December 31, 2015 in San Jorge Hospital, Huesca, Spain. Live status of every patient up to September 2017 and the date of death were retrieved using the national death index. RESULTS: The series included 203 patients: 116 patients (57.1%) underwent a minor amputation and 87 patients (42.9%) underwent a major amputation. Twenty-five patients (12.3%) died in the perioperative period. Significant risk factors of perioperative mortality were undergoing an above-the-knee amputation, postoperative cardiac complications, age >74 years and acute renal failure. Survival rates at 1, 3, and 5 years were 90.6, 72.8, and 55.5% in patients who underwent a minor amputation compared with 70.8, 41.3, and 34.4% in patients who underwent a major amputation, respectively. Log-rank test between the two groups was χ2 = 12.7 (p < 0.01). CONCLUSIONS: Long-term survival was worse in patients who underwent a major amputation with a 5-year mortality of 65.6%. This mortality is worse than what has been reported for some types of common malignancies.

Modern management of diabetic foot osteomyelitis. The when, how and why of conservative approaches.

INTRODUCTION: Diabetic foot osteomyelitis (DFO) has long been considered a complex infection that is both difficult to diagnose and treat, and is associated with a high rate of relapse and limb loss. Areas covered: DFO can usually be diagnosed by a combination of clinical evaluation, serum inflammatory markers and plain X-ray. When the results of these procedures are negative or contradictory, advanced imaging tests or bone biopsy may be necessary. Staphylococcus aureus remains the most frequent microorganism isolated from bone specimens, but infection is often polymicrobial. Antibiotic therapy, preferably with oral agents guided by results of bone culture, for a duration of no more than six weeks, appears to be as safe and effective as surgery in cases of uncomplicated forefoot DFO. Surgery (which should be limb-sparing when possible) is always required for DFO accompanied by necrotizing fasciitis, deep abscess, gangrene or in cases not responding (either clinically or radiographically) to apparently appropriate antibiotic treatment. Expert commentary: Research in the past decade has improved diagnosis and treatment of DFO, and most cases can now be managed with a 'conservative' approach, defined as treatment either exclusively with antibiotics or with surgery removing as little bone and soft tissue as necessary.