Mönckeberg's medial calcific sclerosis in diabetic and non-diabetic foot infections.

The aim of this study was to evaluate the prevalence and extent of lower extremity Mönckeberg's Medial Calcific Sclerosis (MMCS) in patients with and without diabetes in patients admitted to the hospital for foot infections. This study retrospectively reviewed 446 patients admitted to the hospital with a moderate or severe foot infection. We defined diabetes based on ADA criteria and reviewed electronic medical records for demographics, medical history and physical examination data. Anterior-posterior and lateral foot radiographs were examined to identify the presence and extent of vascular calcification. We categorised MMCS based on anatomical location: ankle joint to the navicular-cuneiform joint, Lis Franc joint to metatarsophalangeal joints and distal to the metatarsophalangeal joints. The prevalence of MMCS was 40.6%. The anatomic extent of MMCS was 19.3% in the toes, 34.3% in the metatarsals and 40.6% in the hindfoot/ankle. Calcification was not common solely in the dorsalis pedis artery (DP) (3.8%) or solely in the posterior tibial artery (PT) (7.0%). Usually, both DP and PT arteries were affected by MMCS (29.8%). The prevalence of MMCS was higher in people with diabetes (in hindfoot and ankle [50.1% vs. 9.9%, p ≤ 0.01]; metatarsals [42.6% vs. 5.9%, p ≤ 0.01]; and toes [23.8% vs. 4.0%, p ≤ 0.01]). People with diabetes were 8.9 (CI: 4.5-17.8) times more likely to have MMCS than those without diabetes. This is a group that often has poor perfusion and needs vascular assessment. The high prevalence of MMCS raises questions about the reliability of the conventional segmental arterial Doppler studies to diagnose PAD.

Digital Biomarkers of Gait and Balance in Diabetic Foot, Measurable by Wearable Inertial Measurement Units: A Mini Review.

People with diabetic foot frequently exhibit gait and balance dysfunction. Recent advances in wearable inertial measurement units (IMUs) enable to assess some of the gait and balance dysfunction associated with diabetic foot (i.e., digital biomarkers of gait and balance). However, there is no review to inform digital biomarkers of gait and balance dysfunction related to diabetic foot, measurable by wearable IMUs (e.g., what gait and balance parameters can wearable IMUs collect? Are the measurements repeatable?). Accordingly, we conducted a web-based, mini review using PubMed. Our search was limited to human subjects and English-written papers published in peer-reviewed journals. We identified 20 papers in this mini review. We found preliminary evidence of digital biomarkers of gait and balance dysfunction in people with diabetic foot, such as slow gait speed, large gait variability, unstable gait initiation, and large body sway. However, due to heterogeneities in included papers in terms of study design, movement tasks, and small sample size, more studies are recommended to confirm this preliminary evidence. Additionally, based on our mini review, we recommend establishing appropriate strategies to successfully incorporate wearable-based assessment into clinical practice for diabetic foot care.

A Critical Look at a Diabetic Foot Randomized Controlled Trial: Can You Ever Have Too Many Patients?

The objective of this article series is to teach approaches for critical appraisal to consumers of medical literature. The aim is to build a deeper understanding of standard procedure in clinical research so clinicians can determine whether medical evidence can be applied to their practices. We will choose published articles with methodological flaws to serve as discussion points. In the first article of this series, we will proceed section by section through an article to teach readers what is usually reported, and illustrate what was done correctly and what was not. Subsequently, later articles in this series of critical appraisals will discuss more focused topics. There were several interesting flaws in our first examined paper. This study provides the unusual flaw of reporting a sample size justification and then exceeding enrollment. In addition, the authors enrolled a relatively large number of subjects (n = 16) that evidently completed the study but were subsequently excluded from analysis because they did not fit the inclusion and exclusion criteria.

Lyopreserved amniotic membrane is cellularly and clinically similar to cryopreserved construct for treating foot ulcers.

We compared cellular viability between cryopreserved and lyopreserved amniotic membranes and clinical outcomes of the lyopreserved construct in a prospective cohort study of 40 patients with neuropathic foot ulcers. Patients received weekly application of lyopreserved membrane for 12 weeks with standard weekly debridement and offloading. We evaluated the proportion of foot ulcers that closed, time to closure, closure trajectories, and infection during therapy. We used chi-square tests for dichotomous variables and independent t-tests for continuous variables with an alpha of α = .10. Cellular viability was equivalent between cryo- and lyopreserved amniotic tissues. Clinically, 48% of subjects' wounds closed in an average of 40.0 days. Those that did not close were older (63 vs 59 years, P = .011) and larger ulcers at baseline (7.8 vs 1.6 cm2 , P = .012). Significantly more patients who achieved closure reached a 50% wound area reduction in 4 weeks compared with non-closed wounds (73.7% vs 47.6%, P = .093). There was no difference in the slope of the wound closure trajectories between closed and non-closed wounds (0.124 and 0.159, P = .85), indicating the rate of closure was similar. The rate of closure was 0.60 mm/day (SD = 0.47) for wounds that closed and 0.50 mm/day (SD = 0.58) for wounds that did not close (P = .89).

The effect of continuous diffusion of oxygen treatment on cytokines, perfusion, bacterial load, and healing in patients with diabetic foot ulcers.

To evaluate continuous diffusion of oxygen therapy (CDO) on cytokines, perfusion, and bacterial load in diabetic foot ulcers we evaluated 23 patients for 3 weeks. Tissues biopsies were obtained at each visit to evaluate cytokines and quantitative bacterial cultures. Perfusion was measured with hyperspectral imaging and transcutaneous oxygen. We used paired T tests to compare continuous variables and independent T tests to compare healers and nonhealers. There was an increase from baseline to week 1 in TGF-ß (P = .008), TNF-α (P = .014), VEGF (P = .008), PDGF (P = .087), and IGF-1 (P = .058); baseline to week 2 in TGF-ß (P = .010), VEGF (P = .051), and IL-6 (P = .031); and baseline to week 3 with TGF-ß (P = .055) and IL-6 (P = .054). There was a significant increase in transcutaneous oxygen after 1 week of treatment on both medial and lateral foot (P = .086 and .025). Fifty-three percent of the patients had at least a 50% wound area reduction (healers). At baseline, there were no differences in cytokines between healers and nonhealers. However, there was an increase in CXCL8 after 1 week of treatment (P = .080) and IL-6 after 3 weeks of treatment in nonhealers (P = .099). There were no differences in quantitative cultures in healers and nonhealers.

Reviewing recommendations from the IWGDF 2023 guidelines on the diagnosis and treatment of active Charcot neuro-osteoarthropathy: highlighting the role of temperature monitoring with illustrative case reports.

The International Working Group on the Diabetic Foot (IWGDF) has consistently published evidence-based guideline recommendations on the prevention and management of diabetes-related foot complications. In 2023, the group published their first guidelines on the diagnosis and treatment of Charcot neuro-osteoarthropathy (CNO) in persons with diabetes. The guidelines highlight 26 recommendations based on 4 categories: diagnosis, identification of remission, treatment, and prevention of re-activation. As reviewed in the guidelines, there are 2 recommendations suggesting the use of temperature assessment and monitoring as a tool for management of patients with CNO. Utilizing the systematic review and the GRADE system of evaluation, the authors deemed the level of evidence around temperature monitoring and Charcot to be low with a conditional recommendation for use. The purpose of this manuscript is to summarize the IWGDF guidelines while highlighting the role of foot temperature monitoring. Several case examples are given to illustrate the use of temperature monitoring in patients with CNO. Until there are guidelines determining active vs quiescent CNO, skin temperature monitoring can be a fast, easy-to-use, and effective tool for the clinician.

Foot abscesses with no accompanying wound: clinical presentation and pathogens.

INTRODUCTION: Acute bacterial infections of the skin and soft tissue are common and often pose serious complications, most commonly caused by Streptococcus species and Staphylococcus aureus. OBJECTIVE: The authors report clinical presentation and pathogens in patients with a foot abscess and no wound. METHODS: The authors retrospectively evaluated the demographics, clinical presentation, and microbiology from 20 patient records. RESULTS: Twenty patients were identified. Fifteen were male (75%), and 10 patients (50%) had DM. Patients presented to the hospital 7.8 ± 4.8 days after onset of symptoms and underwent surgery 2.0 ± 0.9 days from admission. Patients underwent 2.4 ± 1.0 surgeries while admitted. Patients with DM presented with significantly higher erythrocyte sedimentation rate than patients without DM (66.6 ± 46.1 vs 43.3 ± 26.2; P = .02). There were no polymicrobial infections based on deep intraoperative tissue cultures. Seven patients had methicillin-sensitive S aureus (35%), 4 had Streptococcus agalactiae (20%), 3 had methicillin-resistant S aureus (15%), 1 had Streptococcus pyogenes (5%), 1 had Escherichia coli (5%), 1 had Streptococcus dysgalactiae (5%), 1 had an unidentified Streptococcus species (5%), and 2 had no growth (10%). CONCLUSION: Patients with foot abscess and no wounds had single-pathogen infections, predominantly Staphylococcus and Streptococcus.

Mönckeberg's Medial Calcific Sclerosis Makes Traditional Arterial Doppler's Unreliable in High-Risk Patients with Diabetes.

OBJECTIVE: To assess Mönckeberg's medial calcific sclerosis (MMCS) severity in patients with a diabetic foot infection. METHODS: This was an analysis of 2 randomized clinical trials in which we evaluated the treatment of 233 patients admitted to the hospital for moderate and severe foot infections. Arterial calcification was defined as visible radiopaque arteries on foot and ankle radiographs, recorded as the most distal visible artery involved (toes, metatarsals, and ankle/hindfoot). RESULTS: Most subjects (57.1%, n = 133) had MMCS, with extension to toes in 79 (59.4%), to metatarsals in 32 (24.1%), and to ankle/hindfoot in 22 patients (16.5%). In 7 patients (5.2%) MMCS was solely seen in dorsalis pedis (DP) artery, in 13 patients (9.8%) in posterior tibialis (PT) artery, and in 113 patients (85.0%) MMCS was seen in both arteries. Only 29.2% (n = 68) of DP arteries and 34.8% (n = 81) of PT arteries were not compressible by Doppler. DP and PT arteries were not compressible more often in MMCS (DP 34.3% vs 20.4%, P = .02 and PT 43.1% vs 21.4%, P < .01), toe-brachial indices of ≥0.7 were significantly more common in people without MMCS (46.0% vs 67.4%, P < .01). In contrast, there were no differences in skin perfusion pressure measurements (>50 mmHg; 67.7% vs 68.0%, P = .96), waveforms (biphasic/triphasic 83.5% vs 77.0%, P = .22), and pulse volume recording (9.6 ± 3.3 vs 13.7 ± 36.0) between patients with and without MMCS. CONCLUSION: MMCS is common in patients with diabetic foot infections. MMCS is associated with noncompressible arterial Doppler studies and likely interferes with the accuracy of arterial Doppler studies.

Limited Clinical Utility of Routine Mycobacterial Cultures for the Management of Diabetic Foot Infections.

Mycobacterial infections of the foot and ankle are uncommon. In a cohort of 2340 patients with diabetic foot infection (DFI) in a region with increased prevalence of mycobacterial disease, we identified no clinically significant positive cultures over a 3-year period. Routine mycobacterial culture of DFIs is of limited clinical utility.

Meta-Analysis: Outcomes of Surgical and Medical Management of Diabetic Foot Osteomyelitis.

Background: The aim of this study was to evaluate clinical outcomes in the published literature on medical and surgical management of diabetic foot osteomyelitis (DFO). Methods: A PubMed and Google Scholar search of articles relating to DFO was performed over the dates of January 1931 to January 2020. Articles that involved Charcot arthropathy, case reports, small case series, review articles, commentaries, nonhuman studies, and non-English articles were excluded. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool was used to rate the bias of each study. A meta-analysis was performed using random-effects and inverse variance methods. The search yielded 1192 articles. After review and the removal of articles that did not meet inclusion criteria, 28 articles remained. Eighteen articles were related to the medical management of DFO and 13 articles were related to surgical management. Three articles looked at a combination of medical and surgical management and were included in both groups. Heterogeneity was evaluated using Cochran Q, I 2, τ2, and τ. Results: The average success rate was 68.2% (range, 17.0%-97.3%) for medical treatment and 85.7% (range, 65.0%-98.8%) for surgical and medical treatment. There were significant inconsistencies in accounting for peripheral arterial disease and peripheral neuropathy. There was significant heterogeneity in outcomes between studies. However, there was a high rate of successful treatment and a wide range between patients with medical treatment and combined surgical and medical treatment. Conclusions: Additional properly designed prospective studies with gold-standard references for diagnosing osteomyelitis are needed to help determine whether medical management of DFO can be successful without surgical intervention.

Remote Temperature Monitoring in Patients With Visual Impairment Due to Diabetes Mellitus: A Proposed Improvement to Current Standard of Care for Prevention of Diabetic Foot Ulcers.

BACKGROUND: Two debilitating sequelae of diabetes are foot ulcerations and vision impairing conditions including retinopathy, open-angle glaucoma, and cataracts. Current standard of care recommends daily visual screening of feet. Despite willingness, many patients are impeded by visual impairment. We investigate whether once-daily remote temperature monitoring can improve self-screening for patients at risk for diabetic foot complications. METHODS: We followed four male veterans with diabetes mellitus, peripheral neuropathy, impaired visual acuity, and at least one other diabetes-related visual impairment in a high-risk podiatry clinic. Patients received a telemedicine remote temperature monitoring mat and instructed on proper daily use. Each patient developed a "hotspot," defined as a 1.75°C localized temperature difference between matched pedal locations, which resulted in telephone triage outreach. RESULTS: In three cases, outreach resulted in a sooner appointment where patients were found to have a relevant outcome at the hotspot. Patients in cases 1-3 had University of Texas (UT) 1A ulcerations. The patient in case 4 had inflammation from trauma. All patients had refractive errors plus another vision impairing condition that potentially delayed identification of lesions. Patients in cases 1 and 2 have cataracts, patients in cases 2 and 3 have retinopathy, and patient in case 4 has glaucoma. CONCLUSIONS: As an adjunct to daily preventative diabetic self-care, once-daily remote temperature monitoring technology can augment self-screening to prompt necessary outreach and treatment and potentially prevent costly and debilitating diabetic foot complications. This case series serves as a pilot study for real-world application of thermometry, where further large-scale research is needed.

Remote Temperature Monitoring in Diabetic Foot Ulcer Detection.

INTRODUCTION: Diabetic foot ulcers (DFUs) are associated with increased morbidity, mortality, and resource utilization. Remote temperature monitoring (RTM) is an evidence-based and recommended component of standard preventative foot care for high-risk populations that can detect the inflammation preceding and accompanying DFUs. OBJECTIVE: This case series illustrates the use of a RTM foot mat for the early detection and prevention of DFUs in patients with a history of DFUs. MATERIALS AND METHODS: Three patients with a history of diabetes, neuropathy, and DFUs were provided a RTM foot mat and instructed in its daily use. Persistent localized temperature differences exceeding 1.75˚C between the left and right feet prompted the clinical staff to call the patient to collect subjective history for further triage. RESULTS: Each patient presented with persistent temperature differences exceeding 1.75˚C. In one case, the patient was instructed to offload, and during a subsequent clinical exam, a callus was debrided and accommodative insoles were issued, resulting in resolution of the temperature differences. In the other 2 cases, the RTM foot mat prompted communication with and examination of the patient when there was damaged tissue deep to callus, resulting in early detection and treatment of uninfected DFUs. CONCLUSIONS: The findings of this case series are consistent with literature supporting the use of RTM for high-risk patients.

Fully Synthetic Bioengineered Nanomedical Scaffold in Chronic Neuropathic Foot Ulcers.

INTRODUCTION: Chronic ulcerations on weightbearing surfaces of the lower extremities are uniquely challenging and can lead to complications such as infection or amputation. OBJECTIVE: This 3-patient case series of 4 chronic wounds of various etiologies outlines the use of a fully synthetic bioengineered nanomedical scaffold that exhibits durability and allows for cell migration and angiogenesis while resisting enzymatic degradation. MATERIALS AND METHODS: The nanomedical scaffold was rehydrated in sterile saline at room temperature for 3 to 5 minutes until translucent and pliable, then it was fenestrated with a scalpel. Following sharp debridement, it was affixed to the ulcer. A nonadherent dressing was applied, followed by applying a moist sterile dressing in a bolster fashion. RESULTS: All 4 ulcers reached the primary endpoints of granulation, as well as decreased wound size, using the nanomedical scaffold. CONCLUSIONS: The nanomedical scaffold successfully reduced the ulcer depths, stimulated granulation tissue while preventing necrosis, and helped the wounds remain infection free. The outcome of this case series suggests a fully synthetic bioengineered nanomedical scaffold can be used as an alternative to human or animal extracellular matrix in chronic, hard-to-heal neuropathic ulcers.