MRSA infection, re-infection and clinical outcomes in diabetic foot infections.

The aim was to investigate methicillin-resistant Staphylococcus aureus (MRSA) incidence, conversion and outcomes in diabetic foot infections (DFIs). This is a pooled patient-level analysis of combined data sets from two randomised clinical trials including 219 patients admitted to the hospital with moderate or severe DFIs. Intraoperative bone and tissue cultures identified bacterial pathogens. We identified pathogens at index infections and subsequent re-infections. We identified MRSA conversion (MSSA to MRSA) in re-infections. MRSA incidence in index infections was 10.5%, with no difference between soft tissue infections (STIs) and osteomyelitis (OM). MRSA conversion occurred in 7.7% of the re-infections in patients who initially had MSSA in their cultures. Patients with re-infection were 2.2 times more likely to have MRSA compared to the first infection (10.5% vs. 25.8%, relative risk [RR] = 2.2, p = 0.001). Patients with MRSA had longer antibiotic treatment during the 1-year follow-up, compared to other pathogens (other 49.8 ± 34.7 days, MRSA 65.3 ± 41.5 days, p = 0.04). Furthermore, there were no differences in healing, time to heal, length of stay, re-infection, amputation, re-ulceration, re-admission, surgery after discharge and amputation after discharge compared to other pathogens. The incidence of MRSA at the index was 10.5% with no difference in STI and OM. MRSA incidence was 25.8% in re-infections. The RR of having MRSA was 2.2 times higher in re-infections. Patients with MRSA used more antibiotics during the 1-year follow-up. Furthermore, there were no differences in clinical outcomes compared to other bacterial pathogens.

Parenteral Vancomycin in the Treatment of MRSA-Associated Diabetic Foot Infections: An Unnecessary Risk.

Diabetic foot infections (DFIs) are a common and costly complication of diabetes. Soft tissue and bone infections in DFIs frequently lead to amputation and/or sepsis which can be costly for both the patient and the healthcare system. Staphylococcus aureus is the most commonly identified causative agent in DFIs, and people with diabetes may have an increased risk of infection with methicillin-resistant Staphylococcus aureus (MRSA). In addition to increased susceptibility to severe infection, MRSA in DFIs is associated with high rates of treatment failure, morbidity, and hospitalization costs meaning appropriate treatment is a high priority. While hospitalized patients are usually treated with intravenous (IV) vancomycin, this can be costly in terms of inpatient stays, staffing costs, and adverse events. For example, vancomycin-associated acute kidney injury not only delays hospital discharge and increases costs but is also a particular concern for patients with diabetes who already have an increased risk of kidney problems. Vancomycin-resistant strains of S. aureus have also been identified, which means that alternative treatment options may need to be explored. Treatment alternatives to IV vancomycin, including oral antibiotics, have been shown to provide similar efficacy, with reduced costs, outpatient or home-based administration, and with fewer serious adverse effects. Although infectious disease specialists often use IV vancomycin alone, or in combination, as a first-line therapeutic option, they are increasingly seeing the value of outpatient or at-home oral antibiotics as an alternative. This manuscript reviews the evidence for true costs of vancomycin therapy for MRSA-associated DFIs and examines the alternatives.

The infected diabetes-related foot: Comparison of erythrocyte sedementation rate/albumin and C-reactive protein/albumin ratios with erythrocyte sedimentation rate and C-reactive protein to differentiate bone and soft tissue infections.

The objective of this study was to evaluate the effectiveness of C-reactive protein (CRP)/albumin, erythrocyte sedimentation rate (ESR)/albumin ratio, ESR, CRP and albumin to differentiate bone and soft tissue infection in persons with diabetes. We retrospectively evaluated 242 individuals admitted to hospital with diabetes-related foot infections (DFI). We categorised DFI cases as either bone (OM) or soft tissue infection based on bone culture and/or histology. We evaluated the diagnostic accuracy of CRP, ESR, albumin, CRP/albumin and ESR/albumin as biomarkers to diagnose OM in persons with diabetes. The median age was 53 years (74% male). There were 224 diabetes-related patients of which 125 had been diagnosed with osteomyelitis. The ESR/albumin and CRP/albumin ratios cut-points were >17.84 and >1.83, respectively. ESR/albumin and CRP/albumin ratios had similar diagnostic parameters: AUC (0.71, 0.71), sensitivity (70.0%, 57.0%), specificity (62.0%, 75.0%), positive predictive value (67.0%, 71.0%) and negative predictive value (66.0% and 71.0%). In contrast diagnostic efficiency of CRP and ESR were AUC 0.71 and 0.71, sensitivity (45.6%, 71.2%), specificity (85.5%, 60.7%), positive predictive value (70.0%, 65.9%) and negative predictive value (59.5%, 66.4%), respectively. When comparing area under the curves, the results showed that ESR/albumin was not significantly different to ESR alone (Delong test pvs ESR >0.1). Similarly, CRP/albumin was not significantly different to CRP alone (Delong test pvs CRP >0.1). In conclusion, ESR/albumin and CRP/albumin ratios provided comparable results as using ESR and CRP alone.

All Feet on Deck: The Role of Podiatry During the COVID-19 Pandemic: Preventing Hospitalizations in an Overburdened Health-Care System, Reducing Amputation and Death in People with Diabetes.

The coronavirus disease of 2019 pandemic is driving significant change in the health-care system and disrupting the best practices for diabetic limb preservation, leaving large numbers of patients without care. Patients with diabetes and foot ulcers are at increased risk for infections, hospitalization, amputations, and death. Podiatric care is associated with fewer diabetes-related amputations, emergency room visits, hospitalizations, length-of-stay, and costs. However, podiatrists must mobilize and adopt the new paradigm of shifts away from hospital care to community-based care. Implementing the proposed Pandemic Diabetic Foot Triage System, in-home visits, higher acuity office visits, telemedicine, and remote patient monitoring can help podiatrists manage patients while reducing the coronavirus disease of 2019 risk. The goal of podiatrists during the pandemic is to reduce the burden on the health-care system by keeping diabetic foot and wound patients safe, functional, and at home.

The Significance of the Global Vascular Guidelines for Podiatrists: Answers to Key Questions in the Diagnosis and Management of the Threatened Limb.

The publication of the Global Vascular Guidelines in 2019 provide evidence-based, best practice recommendations on the diagnosis and treatment of chronic limb-threatening ischemia (CLTI). Certainly, the multidisciplinary team, and more specifically one with collaborating podiatrists and vascular specialists, has been shown to be highly effective at improving the outcomes of limbs at risk for amputation. This article uses the Guidelines to answer key questions for podiatrists who are caring for the patient with CLTI.

Wound Center Without Walls: The New Model of Providing Care During the COVID-19 Pandemic.

The COVID-19 pandemic poses a major challenge in delivering care to wound patients. Due to multiple comorbidities, wound patients are at an increased risk for the most extreme complications of COVID-19 and providers must focus on reducing their exposure risk. The Federal, State, and local governments, as well as payers, have urged hospitals and providers to reduce utilization of nonessential health services, but they also have given more flexibility to shift the site of necessary care to lower risk environments. Providers must be prepared for disruption from this pandemic mode of health care for the next 18 months, at minimum. The wound provider must accept the new normal during the pandemic by adapting their care to meet the safety needs of the patient and the public. The Wound Center Without Walls is a strategy to untether wound care from a physical location and aggressively triage and provide care to patients with wounds across the spectrum of the health system utilizing technology and community-centered care.

Hospital and Surgical Privileges for Doctors of Podiatric Medicine.

The Board of Directors of the American Board of Podiatric Medicine approved the following position statement regarding hospital and surgical privileges for doctors of podiatric medicine on February 27, 2019. This statement is based on federal law, Centers for Medicare and Medicaid Services Conditions of Participation and Standards of the Joint Commission, and takes into account the current education, training, and experience of podiatrists to recommend best practices for hospital credentialing and privileging.

Focused shockwave therapy in diabetic foot ulcers: secondary endpoints of two multicentre randomised controlled trials.

OBJECTIVE: The objective of this paper is to present the secondary safety and efficacy outcomes from two studies of focused extracorporeal shockwave therapy (ESWT) used adjunctively with standard care in the treatment of neuropathic diabetic foot ulcers (DFU) (1A or 2A on the University of Texas grading scheme), compared with sham treatment and standard care. METHOD: We carried out two multicentre, multinational, randomised, sham-controlled, double-blinded, phase III clinical studies using standard care with adjunctive focused ESWT compared with sham treatment and standard care in patients with a DFU. DFUs that did not reduce in volume by at least 50% over two weeks' standard treatment were included. DFUs were randomised and managed with standard care and focused ESWT (pulsed acoustic cellular expression; dermaPACE System, SANUWAVE Health, Inc.) active therapy, or with standard care and sham treatment, four times over a two-week treatment phase in study 1 and up to eight times over 12 weeks in study 2. Standard care continued in both studies throughout the 12-week treatment phase. Secondary outcomes were indicators of wound closure and progression, pain, infection, amputation and recurrence, and device reliability. Efficacy-related secondary endpoints were measured at 12, 20 and 24 weeks. The studies were analysed separately and following statistical comparison to justify the method, as a pooled data set. RESULTS: Wound area reduction (48.6% versus 10.7%, p=0.015, intention to treat (ITT) population with last observation carried forward (LOCF)) and perimeter reduction (46.4% versus 25.0%, p=0.022, ITT population with LOCF) were significantly greater in the active therapy group compared with the sham-treated group, respectively. The difference in time to wound closure in the pooled ITT population was significantly in favour of the active therapy group (84 days versus 112 days for 25% of subjects to reach wound closure in the active and sham-treated groups, respectively; p=0.0346). The proportion of subjects who achieved wound area reduction (WAR) from baseline at week 12 of ≥90% was significantly higher in the active therapy group. The incidence and nature of infection were consistent with previously published studies, and pain was not increased in the active therapy group. Amputation was insignificantly higher in the sham-treated group and recurrence did not differ. The ESWT device was found to be reliable. CONCLUSION: The outcomes for the primary and secondary endpoints from these studies show that ESWT administered adjunctively with standard care is an effective advanced therapy for neuropathic DFUs (grade 1A and 2A) that do not respond to two weeks' standard care alone by reducing wound volume by at least 50%.

Diabetic foot ulcer treatment with focused shockwave therapy: two multicentre, prospective, controlled, double-blinded, randomised phase III clinical trials.

OBJECTIVE: To investigate the efficacy of focused extracorporeal shockwave therapy (ESWT) as an adjunctive treatment for neuropathic diabetic foot ulcers (DFU) (1A or 2A on the University of Texas grading scheme), compared with sham treatment. METHOD: We performed two multicentre, randomised, sham-controlled, double-blinded, phase III clinical trials using focused ESWT compared with sham examining DFUs that did not reduce in volume by ≥50% over 2 weeks' standard treatment immediately prior to randomisation. Patients were enrolled into the trials and randomised for either standard care and focused ESWT (pulsed acoustic cellular expression. dermaPACE System, SANUWAVE Health Inc.) active therapy, or standard care and sham therapy. Both active and sham therapy were administered four times in 2 weeks in study 1 and a maximum of eight times over 12 weeks in study 2. Standard care continued in both studies throughout the 12-week treatment phase. The proportion of DFUs that closed completely by 12, 20 and 24 weeks was measured. RESULTS: The two studies evaluated 336 patients; 172 patients treated with active therapy and 164 managed with a sham device. The demographic characteristics of patients in the two arms of both studies were balanced and statistical comparison of the two studies justified pooling datasets for analysis. Statistically significantly more DFU healed at 20 (35.5% versus 24.4%; p=0.027) and 24 weeks (37.8% versus 26.2%; p=0.023) in the active treatment arm compared with the sham-controlled arm. At 12 weeks the active therapy arm trended to significance (22.7% versus 18.3%). CONCLUSION: The outcome of these two trials suggests that ESWT is an effective therapeutic modality in combination with standard care for neuropathic DFU that do not respond to standard care alone.

The Use of a Sea Salt-based Spray for Diabetic Foot Ulcers: A Novel Concept.

Several patients present to wound healing specialists seeking a natural or alternative medical approach to their wounds. The purpose of this prospective, case-cohort study of 10 patients was to evaluate the use of Oceanzyme Wound Care Spray (Ocean Aid, Inc, Boynton Beach, FL) in improving healing in diabetic foot ulcers during a 12-week period. This product contains water purified by reverse osmosis, coral reef sea salt, lysozyme, and sodium benzoate. The primary endpoint was wound closure, and secondary endpoints were infection rate and wound area reduction. Overall, 2 patients healed, 2 withdrew, and the remaining 6 had an average of 73% reduction in wound area. While more study is needed, the use of this sea salt-based spray may provide a viable alternative for patients seeking a natural therapy for their wound care.

Credentialing guidelines for doctors of podiatric medicine supervising hyperbaric oxygen therapy a position paper.

Hyperbaric oxygen therapy (HBOT) is a useful tool for many conditions within the scope of practice of a Doctor of Podiatric Medicine (DPM). More wound-care clinics are adding HBOT as a service line. The increasing prevalence of DPMs operating inside of these wound-care clinics has raised questions about the licensure and privileging of DPMs to supervise HBOT. This document reviews the safety of outpatient HBOT and provides guidelines for hospitals to credential DPMs to supervise treatments.

The management of diabetic foot ulcers through optimal off-loading: building consensus guidelines and practical recommendations to improve outcomes.

BACKGROUND: We sought to develop a consensus statement for the use of off-loading in the management of diabetic foot ulcers (DFUs). METHODS: A literature search of PubMed for evidence regarding off-loading of DFUs was initially conducted, followed by a meeting of authors on March 15, 2013, in Philadelphia, Pennsylvania, to draft consensus statements and recommendations using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach to assess quality of evidence and develop strength of recommendations for each consensus statement. RESULTS: Evidence is clear that adequate off-loading increases the likelihood of DFU healing and that increased clinician use of effective off-loading is necessary. Recommendations are included to guide clinicians on the optimal use of off-loading based on an initial comprehensive patient/wound assessment and the necessity to improve patient adherence with off-loading devices. CONCLUSIONS: The likelihood of DFU healing is increased with off-loading adherence, and, current evidence favors the use of nonremovable casts or fixed ankle walking braces as optimum off-loading modalities. There currently exists a gap between what the evidence supports regarding the efficacy of DFU off-loading and what is performed in clinical practice despite expert consensus on the standard of care.

The Charcot foot.

The diabetic Charcot foot is rare, but a life-changing event affecting quality of life, and it risks amputation of the limb. There is no high quality evidence base governing treatment, causing clinicians to rely on low-quality, underpowered studies and expert opinion. However, CN is a treatable condition and, with lifestyle modifications and proper footwear, it does not shorten the life span of those afflicted.

External fixation techniques for plastic and reconstructive surgery of the diabetic foot.

Wound healing in high-risk patients with diabetes is often lengthy and fraught with complications. Techniques in plastic and reconstructive surgery of the diabetic foot continue to develop as a result of advances in external fixation. This article highlights the surgical aspect of the diabetic foot with an emphasis on the indications, advantages, technical pearls, and complications with use of external fixation as an adjunct to plastic and reconstructive surgery of the diabetic foot.

The Charcot foot in diabetes.

The diabetic Charcot foot syndrome is a serious and potentially limb-threatening lower-extremity complication of diabetes. First described in 1883, this enigmatic condition continues to challenge even the most experienced practitioners. Now considered an inflammatory syndrome, the diabetic Charcot foot is characterized by varying degrees of bone and joint disorganization secondary to underlying neuropathy, trauma, and perturbations of bone metabolism. An international task force of experts was convened by the American Diabetes Association and the American Podiatric Medical Association in January 2011 to summarize available evidence on the pathophysiology, natural history, presentations, and treatment recommendations for this entity.

The Charcot foot in diabetes.

The diabetic Charcot foot syndrome is a serious and potentially limb-threatening lower-extremity complication of diabetes. First described in 1883, this enigmatic condition continues to challenge even the most experienced practitioners. Now considered an inflammatory syndrome, the diabetic Charcot foot is characterized by varying degrees of bone and joint disorganization secondary to underlying neuropathy, trauma, and perturbations of bone metabolism. An international task force of experts was convened by the American Diabetes Association and the American Podiatric Medical Association in January 2011 to summarize available evidence on the pathophysiology, natural history, presentations, and treatment recommendations for this entity.