Home monitoring of foot skin temperatures to prevent ulceration

OBJECTIVE - To evaluate the effectiveness of at-home infrared temperature monitoring as a preventative tool in individuals at high risk for diabetes-related lower-extremity ulceration and amputation. RESEARCH DESIGN AND METHODS - Eighty-five patients who fit diabetic foot risk category 2 or 3 (neuropathy and foot deformity or previous history of ulceration or partial foot amputation) were randomized into a standard therapy group (n = 41) or an enhanced therapy group (n = 44). Standard therapy consisted of therapeutic footwear, diabetic foot education, and regular foot evaluation by a podiatrist. Enhanced therapy included the addition of a handheld infrared skin thermometer to measure temperatures on the sole of the foot in the morning and evening. Elevated temperatures (>4°F compared with the opposite foot) were considered to be "at risk" of ulceration due to inflammation at the site of measurement. When foot temperatures were elevated, subjects were instructed to reduce their activity and contact the study nurse. Study subjects were followed for 6 months. RESULTS - The enhanced therapy group had significantly fewer diabetic foot complications (enhanced therapy group 2% vs. standard therapy group 20%, P = 0.01, odds ratio 10.3, 95% CI 1.2-85.3). There were seven ulcers and two Charcot fractures among standard therapy patients and one ulcer in the enhanced therapy group. CONCLUSIONS - These results suggest that at-home patient self-monitoring with daily foot temperatures may be an effective adjunctive tool to prevent foot complications in individuals at high risk for lower-extremity ulceration and amputation

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-β (P =.008), TNF-α (P =.014), VEGF (P =.008), PDGF (P =.087), and IGF-1 (P =.058); baseline to week 2 in TGF-β (P =.010), VEGF (P =.051), and IL-6 (P =.031); and baseline to week 3 with TGF-β (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

Does the use of DACC-coated dressings improve clinical outcomes for hard to heal wounds: a systematic review

Reports of overuse and antimicrobial resistance have fuelled some clinicians to adopt alternative wound dressings termed to be non-medicated or non-antimicrobials, which still claim antimicrobial or antibacterial activity. In this PROSPERO-registered systematic review, we evaluated the in vivo clinical evidence for the effectiveness of DACC-coated dressings in chronic, hard to heal wound-related outcomes. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Framework was adopted as the template in constructing this systematic review. The PICO format (Population [or patients], Intervention, Comparison [control], Outcome/s) was used to identify key clinical questions in determining patient outcomes under two domains (infection control and wound healing). A systematic search was performed in PubMed, OVID, Cochrane Library, clinical trial registries and data sources from independent committees. Abstracts of all studies were screened independently by two reviewers, with six further reviewers independently assessing records proceeding to full review. The authors rated the quality of evidence for each of the outcomes critical to decision making. After excluding duplicates, 748 records were screened from the databases, and 13 records were sought for full review. After full review, we excluded a further three records, leaving ten records for data extraction. Three records were narrative reviews, three systematic reviews, two prospective non-comparative before/after studies, one prospective head-to-head comparator cohort study and one retrospective head-to-head comparator cohort study. No RCTs or case versus control studies were identified. The overall quality of clinical evidence for the use of DACC-coated dressing to improve wound infection and wound healing outcomes was assessed as very low. There is an urgent unmet need to perform appropriately designed RCTs or case–control studies. The extracted data provide no clarity and have limited to no evidence to support that using a DACC-coated dressing improves wound infection or wound healing outcomes. Further, there is no evidence to suggest this therapy is either superior to standard of wound care or equivocal to topical antimicrobial agents in the management of infected hard to heal wounds.info:eu-repo/semantics/publishedVersio

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, I2, 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

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)

Predictive value of foot pressure assessment as part of a population-based diabetes disease management program

WSTĘP. Celem pracy była ocena przydatności dynamicznego pomiaru ciśnienia podeszwowego w identyfikacji grupy chorych wysokiego ryzyka powstawania owrzodzeń neuropatycznych. Wybierając punkt odcięcia, szukano optymalnej kombinacji swoistości i czułości wartości ciśnienia podeszwowego, pozwalającej ocenić ryzyko występowania owrzodzeń neuropatycznych. MATERIAŁ I METODY. Grupę 1666 chorych na cukrzycę (50,3% mężczyzn) kolejno zgłaszających się do dużego miejskiego centrum diabetologicznego zakwalifikowano do badania zaplanowanego na 2 lata. Podczas kwalifikacji pacjentów poddano standardowemu badaniu klinicznemu, ze szczególnym uwzględnieniem układu mięśniowo-szkieletowego, a także dokładnej ocenie w miejscowym gabinecie stopy cukrzycowej. WYNIKI. Z całej badanej populacji u 263 chorych (15,8%) owrzodzenie stóp występowało podczas badania wstępnego lub powstało w czasie 24-miesięcznej obserwacji. Jak oczekiwano, podstawowe maksymalne ciśnienie podeszwowe było znamiennie wyższe u osób z grupy z owrzodzeniami niż u osób z grupy bez tej zmiany (95,5 &plusmn; 26,4 vs. 85,1 &plusmn; 27,3 N/cm2, p < 0,001). Zaobserwowano również tendencję do związku wyższego ciśnienia podeszwowego z większą liczbą zniekształceń stopy, jak również z klasyfikacją do grupy wyższego ryzyka rozwoju owrzodzeń (p = 0,0001). Maksymalne ciśnienie podeszwowe nie było odpowiednim, samodzielnym narzędziem identyfikującym chorych z grupy wysokiego ryzyka. Przy zastosowaniu krzywej operacyjno-charakterystycznej (ROC, receiver operating characteristic), po wyłączeniu z analizy pacjentów z nieupośledzonym czuciem powierzchownym, optymalny punkt odcięcia wartości ciśnienia podeszwowego, określony na podstawie najlepszej kombinacji swoistości i czułości, wynosił 87,5 N/cm2, osiągając czułość 63,5% i swoistość 46,3%. WNIOSKI. Uzyskane dane potwierdzają, że podwyższone ciśnienie podeszwowe jest istotnym czynnikiem ryzyka powstawania zespołu stopy cukrzycowej, chociaż analiza ROC sugeruje, że ciśnienie to jako pojedynczy parametr jest słabym wskaźnikiem pozwalającym ocenić ryzyko powstawania owrzodzeń stóp.INTRODUCTION. To evaluate the effectiveness of dynamic plantar pressure assessment to determine patients at high risk for neuropathic ulceration. In choosing the cut point, we looked for an optimum combination of sensitivity and specificity of plantar pressure to screen for neuropathic ulceration. MATERIAL AND METHODS. A total of 1,666 consecutive individuals with diabetes (50.3% male) presenting to a large urban managed care &#8212; based outpatient clinic were enrolled in this longitudinal 2-year outcome study. Patients received a standardized medical and musculoskeletal assessment at the time of enrollment, including evaluation in an onsite gait laboratory. RESULTS. Of the entire population, 263 patients (15.8%) either presented with or developed an ulcer during the 24-month follow-up period. As expected, baseline peak plantar pressure was significantly higher in the ulcerated group than in the group who did not ulcerate (95.5 &plusmn; 26.4 vs 85.1 &plusmn; 27.3 N/cm2, P < 0.001). There was also a trend toward increased pressure with increasing numbers of foot deformities, as well as with increasing foot risk classification (P = 0.0001). Peak pressure was not a suitable diagnostic tool by itself to identify high-risk patients. After eliminating patients without loss of protective sensation, using receiver operating characteristic (ROC) analysis, the optimal cut point, as determined by a balance of sensitivity and specificity, was 87.5 N/cm2, yielding a sensitivity of 63.5% and a specificity of 46.3%. CONCLUSIONS. The data from this evaluation continue to support the notion that elevated foot pressure is an important risk factor for foot complications. However, the ROC analysis suggests that foot pressure is a poor tool by itself to predict foot ulcers

A metatranscriptomic approach to explore longitudinal tissue specimens from non-healing diabetes related foot ulcers

Cellular mechanisms and/or microbiological interactions which contribute to chronic diabetes related foot ulcers (DRFUs) were explored using serially collected tissue specimens from chronic DRFUs and control healthy foot skin. Total RNA was isolated for next-generation sequencing. We found differentially expressed genes (DEGs) and enriched hallmark gene ontology biological processes upregulated in chronic DRFUs which primarily functioned in the host immune response including: (i) Inflammatory response; (ii) TNF signalling via NFKB; (iii) IL6 JAK-STAT3 signalling; (iv) IL2 STAT5 signalling and (v) Reactive oxygen species. A temporal analysis identified RN7SL1 signal recognition protein and IGHG4 immunoglobulin protein coding genes as being the most upregulated genes after the onset of treatment. Testing relative temporal changes between healing and non-healing DRFUs identified progressive upregulation in healed wounds of CXCR5 and MS4A1 (CD20), both canonical markers of lymphocytes (follicular B cells/follicular T helper cells and B cells, respectively). Collectively, our RNA-seq data provides insights into chronic DRFU pathogenesis

Negative pressure wound therapy with instillation: International consensus guidelines update.

The use of negative pressure wound therapy with instillation and dwell time (NPWTi-d) has gained wider adoption and interest due in part to the increasing complexity of wounds and patient conditions. Best practices for the use of NPWTi-d have shifted in recent years based on a growing body of evidence and expanded worldwide experience with the technology. To better guide the use of NPWTi-d with all dressing and setting configurations, as well as solutions, there is a need to publish updated international consensus guidelines, which were last produced over 6 years ago. An international, multidisciplinary expert panel of clinicians was convened on 22 to 23 February 2019, to assist in developing current recommendations for best practices of the use of NPWTi-d. Principal aims of the meeting were to update recommendations based on panel members\u27 experience and published results regarding topics such as appropriate application settings, topical wound solution selection, and wound and patient characteristics for the use of NPWTi-d with various dressing types. The final consensus recommendations were derived based on greater than 80% agreement among the panellists. The guidelines in this publication represent further refinement of the recommended parameters originally established for the use of NPWTi-d. The authors thank Karen Beach and Ricardo Martinez for their assistance with manuscript preparation

IWGDF/IDSA Guidelines on the Diagnosis and Treatment of Diabetes-related Foot Infections (IWGDF/IDSA 2023)

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the management and prevention of diabetes-related foot diseases since 1999. The present guideline is an update of the 2019 IWGDF guideline on the diagnosis and management of foot infections in persons with diabetes mellitus. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was used for the development of this guideline. This was structured around identifying clinically relevant questions in the P(A)ICO format, determining patient-important outcomes, systematically reviewing the evidence, assessing the certainty of the evidence, and finally moving from evidence to the recommendation. This guideline was developed for healthcare professionals involved in diabetes-related foot care to inform clinical care around patient-important outcomes. Two systematic reviews from 2019 were updated to inform this guideline, and a total of 149 studies (62 new) meeting inclusion criteria were identified from the updated search and incorporated in this guideline. Updated recommendations are derived from these systematic reviews, and best practice statements made where evidence was not available. Evidence was weighed in light of benefits and harms to arrive at a recommendation. The certainty of the evidence for some recommendations was modified in this update with a more refined application of the GRADE framework centred around patient important outcomes. This is highlighted in the rationale section of this update. A note is also made where the newly identified evidence did not alter the strength or certainty of evidence for previous recommendations. The recommendations presented here continue to cover various aspects of diagnosing soft tissue and bone infections, including the classification scheme for diagnosing infection and its severity. Guidance on how to collect microbiological samples, and how to process them to identify causative pathogens, is also outlined. Finally, we present the approach to treating foot infections in persons with diabetes, including selecting appropriate empiric and definitive antimicrobial therapy for soft tissue and bone infections; when and how to approach surgical treatment; and which adjunctive treatments may or may not affect the infectious outcomes of diabetes-related foot problems. We believe that following these recommendations will help healthcare professionals provide better care for persons with diabetes and foot infections, prevent the number of foot and limb amputations, and reduce the patient and healthcare burden of diabetes-related foot disease

Interventions in the management of diabetes-related foot infections: 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 from 30 June 2018 to 30 June 2022. We combined this search with our previous literature search of a systematic review performed in 2020, in which the infection committee of the International Working Group on the Diabetic Foot searched the literature until June 2018. We defined the context of the literature by formulating clinical questions of interest, then developing structured clinical questions (Patients-Intervention-Control-Outcomes) 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 methodological quality. Our literature search identified a total of 5,418 articles, of which we selected 32 for full-text review. Overall, the newly available studies we identified since 2018 do not significantly modify the body of the 2020 statements for the interventions in the management of diabetes-related foot infections. The recent data confirm that outcomes in patients treated with the different antibiotic regimens for both skin and soft tissue infection and osteomyelitis of the diabetes-related foot are broadly equivalent across studies, with a few exceptions (tigecycline not non-inferior to ertapenem [±vancomycin]). The newly available data suggest that antibiotic therapy following surgical debridement for moderate or severe infections could be reduced to 10 days and to 3 weeks for osteomyelitis following surgical debridement of bone. Similar outcomes were 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 recent adjunctive therapies, such as cold plasma for infected foot ulcers and bioactive glass for osteomyelitis. Our updated systematic review confirms a trend to a better quality of the most recent trials and the need for further well-designed trials to produce higher quality evidence to underpin our recommendations