Outcome Of Diabetic Foot Ulcers Research Articles

RETRACTION: The effect of negative pressure wound therapy on the outcome of diabetic foot ulcers: A meta-analysis.

N. Zhang , Y. Liu , W. Yan , F. Liu , "The effect of negative pressure wound therapy on the outcome of diabetic foot ulcers: A meta-analysis," International Wound Journal 21, no. 4 (2024): e14886, https://doi.org/10.1111/iwj.14886. The above article, published online on 23 April 2024, in Wiley Online Library (http://onlinelibrary.wiley.com/), has been retracted by agreement between the journal Editor in Chief, Professor Keith Harding; and John Wiley & Sons, Ltd. Following an investigation by the publisher, the parties have concluded that this article was accepted solely on the basis of a compromised peer review process. Therefore, the article must be retracted. The authors did not respond to the notice of retraction.

A Comprehensive Approach for Diabetic Foot Ulcer Management

Objectives: This study aims to evaluate the efficacy of a comprehensive management plan in the treatment of diabetic foot ulcers (DFUs). Evaluating the effects of wound debridement on the outcomes of diabetic foot ulcers, advanced dressings, blood sugar control, and offloading strategies are the main objectives. The study also intends to investigate the function of surgery in managing chronic ulcers and preventing recurrences. The goal is to offer advice for managing DFUs optimally and lowering related morbidity based on evidence. Method: The intervention program includes techniques like wound debridement, advanced dressings, unloading modalities, blood sugar level control, and, where necessary, surgical treatments. Growth factors, electrical stimulation, negative pressure wound therapy, bio-engineered skin, and hyperbaric oxygen therapy are among the many treatments that are included. Regression models are among the statistical analyses used to assess the efficacy of the overall management strategy. Results: Significant findings are presented in the results section, which shows how the holistic management strategy improves DFU outcomes. Improved wound healing rates, reduced infection incidents, and enhanced patient-reported outcomes are highlighted. The results underscore the significance of maintaining blood sugar levels, wound debridement, and incorporating various therapeutic modalities in DFU management. Conclusion: This study concludes by recommending a thorough and interdisciplinary approach to DFU management. Maintaining blood sugar levels, debridement of the wound, sophisticated dressings, unloading techniques, and surgical procedures are among the effective strategies that help reduce morbidity and prevent serious complications related to diabetic foot ulcers. Additional investigation is necessary to enhance and broaden these results for ongoing progress in the management of diabetic foot ulcers.

The role of vitamin D in diabetic foot ulcer; an umbrella review of meta-analyses.

Complications related to diabetic foot ulcers (DFU) due to diabetes are increasing. One of the factors influencing the management and treatment of complications related to DFU is the vitamin D serum levels of patients. Therefore, we sought to comprehensively review meta-analyses from randomized controlled trials and observational studies examining the link between serum vitamin D levels and DFU outcomes in diabetic patients. We searched PubMed, Scopus, and ISI Web of Science until September 2024 and extracted the required data from related articles according to Inclusion criteria. The certainty of the evidence and the quality of conduct of the published meta-analyses were rated using the ASMTAR 2 tools, respectively. A total of 8 meta-analyses studies that met inclusion criteria were included. Based on the obtained results, it has been noted that individuals with DFU exhibit serum vitamin D levels significantly lower, ranging from -7.14 (5.44, 8.83) to -0.93 (95% CI: 0.17, 1.68) ng/ml, compared to those with diabetes but without DFU. Furthermore, individuals exhibiting severe vitamin D deficiency are found to be at least 1.82 times more susceptible to developing DFU. Conversely, administering varying doses of vitamin D supplementation has been shown to positively affect the size and number of ulcers in DFU patients. This study suggests a potential link between lower levels of vitamin D in the blood and the risk of DFU, hinting at the benefits of vitamin D supplementation in improving outcomes associated with DFU. However, caution is warranted due to the potential bias present in the included studies.

Single-Cell Analysis of Debrided Diabetic Foot Ulcers Reveals Dysregulated Wound Healing Environment in Non-Hispanic Blacks

Diabetic foot ulcer (DFU) is a critical complication of diabetes, but the wound microenvironment and its healing process are not completely understood. In this study, we optimized single-cell profiling from sharp debrided ulcers. Our findings demonstrate that healing-DFUs were significantly enriched with distinct fibroblasts expressing genes related to inflammation (CHI3L1, IL6) and extracellular matrix remodeling (ASPN), validating our previous studies on surgically resected ulcers. The race-focused analysis depicted lower expression of key healing-associated genes such as CHIL3L1, MMP11, and SFRP4 in fibroblasts of non-Hispanic Black (NHB) patients compared to White patients. In cellular communication analysis, healing enriched fibroblasts of NHBs exhibited upregulation of signaling pathways such as WNT while those of White showed IGF and MK pathways upregulation. Our findings advocate race as a risk marker of DFU outcomes, likely reflecting underlying disparities in environmental exposures and access to care that profoundly influence healing markers. Using sharp debrided tissues for single-cell assays, this study highlights the need for in-depth investigations into dysregulated wound healing microenvironments of under-represented racial groups.

SOCIOECONOMIC FACTORS AND HEALTHCARE ACCESS: THEIR ROLE IN THE MANAGEMENT AND OUTCOMES OF DIABETIC FOOT ULCERS

Objective: Diabetic foot ulcers (DFUs) are a significant complication of diabetes mellitus, affecting millions globally and presenting considerable challenges to healthcare systems. While clinical aspects of DFUs are well-documented, socioeconomic factors and healthcare access play crucial roles in their management and outcomes. This study investigates how socioeconomic status (SES), healthcare accessibility, and patient education influence DFU prevention, treatment, and prognosis. Methods: A prospective, cross-sectional observational study was conducted over 13 mo at the Department of General Surgery, Command Hospital (Western Command), Chandimandir. Fifty patients with DFUs were enrolled based on specific inclusion and exclusion criteria. Data were collected on demographic details, lifestyle habits, comorbidities, and specifics of diabetes and DFU. Ulcer characteristics, wound cultures, and outcomes were analyzed using SPSS version 21.0. Results: The study population had a mean age of 60.10 y, with a predominance of males (78%). Smoking and obesity emerged as significant risk factors, with smoking more prevalent among males and obesity more common in females. The distribution of ulcer locations and the microbial profile, dominated by Staphylococcus aureus, underline the complexity of DFU management. These findings highlight the influence of socioeconomic factors and healthcare access on DFU outcomes. Conclusion: Effective DFU management requires a holistic approach that extends beyond clinical treatment to address socioeconomic factors and healthcare access. Tailored interventions that consider these broader determinants of health are essential for improving DFU outcomes and patient quality of life. Addressing healthcare disparities can significantly reduce the burden of DFUs, creating a more equitable and effective framework for diabetes care.

The effect of the different waves of COVID-19 pandemic on the outcome of diabetic foot ulcers.

COVID-19 pandemic has massively impacted human health. We studied the effect of COVID-19 on outcome of Diabetic foot ulcers (DFUs). We recruited 483 people with DFUs from June 2020 to April 2022 (pandemic) together with a matched group of 226 people with DFU from March 2019 to March 2020 (pre-pandemic). Primary endpoint was outcome of ulcers-healed or amputation (major/minor). It was sub-analysed into 3 waves of COVID-19. Secondary endpoint was healing of individual types of DFUs. Basic anthropometric data included site and type of ulcer (ischemic or neuropathic), duration, presence or absence of infection and Wagner's grading of DFUs was collected for all patients. Diagnosis of peripheral neuropathy was done by monofilament testing and peripheral arterial disease by handheld Doppler and ankle brachial index (ABI). Standardized treatment protocol was provided. All patients were monitored for 6 months. In the pandemic group 323 (66.9%) patients in whom ulcers healed, 70 (14.5%) underwent minor amputation, 11 (2.2%) major amputation, 29 (6%) were lost to follow up, 22 (4.6%) were not healed. Rate of healing of DFU was higher (66.9% vs 53.5%) and rate of amputation was lower (16.7% vs 23.4%) in the pandemic group than in the pre-pandemic group (P = 0.001 and 0.037 respectively). Rate of healing in first, second and third wave was 65.4%, 75.2%, 58.3% respectively (P = 0.001). Neuropathic ulcers though less prevalent (49.8% vs 57.8%) in the first two waves than in the third wave, healing was better (79.3% vs 75.6%) in the first two waves than in the third wave (P = 0.085 and 0.488 respectively). Similarly, amputation rates in ischemic and neuro-ischemic ulcers were greater in the third wave than first two waves (46.7% vs 15.7%, P = 0.049). During the COVID-19 pandemic, healing of neuropathic ulcers was better, especially in the first and second waves and travel restriction may have accounted for this. However, worsening of ischemic and neuro-ischemic ulcers was observed with more amputation in these two groups. Conversely, in the third wave withdrawal of lockdown led to worsening of DFUs resulting in less healing and more amputation.

The Model and Efficacy of Online Nurse-led on the Clinical Outcome of Diabetic Foot Ulcers: A Systematic Review of Randomized Controlled Trials

Background: The most frequent consequence for those with diabetes mellitus is diabetic foot ulcers. Diabetic ulcer treatment must be done properly and on time. The development of online-based intervention by nurses, such as messaging health, may improve the clinical outcome of diabetic foot ulcers by providing easier access, more convenience, and cost-effectiveness, especially for patients in rural areas. Objective: This study aimed to perform a systematic review and meta-analysis the models and efficacy of online nurse-led intervention on clinical outcomes of diabetic foot ulcers. Methods: Randomized Controlled Trials were searched by using PubMed, Scopus, and Google Scholar. The final inclusion study analyzed and synthesized by tabulation, clusterization, contextual and thematic approach, and assessed risk of bias by using RoB 2.0. The study used Mantel Haenszel method. Results: Five randomized controlled trials with 1399 total number of participants were included. There are three studies with some concerns and two studies with low risk of bias. The nurse-led model for diabetic foot ulcer care consists of phone and web-based that conducted by nurse (community nurses and clinical nurses) and doctor specialists are involved in the service. The meta-analysis for amputation outcome showed that telehealth has more favor amputation number with RR 0.6 (95 % CI 0.43 - 0.84; p = 0.003). For healing wounds and mortality outcome, telehealth with RR 1.07 (95% CI 0.99 - 1.16; p = 0.11) and RR 1.37 (95 % CI 0.78 - 2.40; p =0.28), respectively. Conclusions: Phone and web-based may improve clinical outcome of diabetic foot ulcers in terms of amputation outcome, but standard care still more favor in higher wound healing outcome and significantly lower mortality rate.

Characteristics and outcomes of diabetic foot ulcers treated with surgical debridement and standardized wound care.

Diabetic foot ulcers (DFUs) pose a significant clinical challenge, often leading to amputations and hospitalisation. This study aimed to investigate the characteristics and outcomes of DFUs treated with surgical debridement and standardised wound care. This descriptive cross-sectional study focused on diabetic patients with appropriate vascular conditions, as determined by an Ankle Brachial Index >0.9. Based on their infection status, participants were admitted to Poursina Hospital in Rasht, Iran, and subjected to initial supportive measures, antibiotic therapy and surgical debridement. The study incorporated primary treatment with wet bandages, silver spray and fibrinolysin ointment. Statistical analysis employed SPSS 22 software. Most patients were male (54.7%) and under 60 years old (50.7%). Overweight status was prevalent in 69.3% of diabetic ulcer patients, amongst whom 48% underwent wrist debridement. The 64% and 36% of the cases had grade III and grade II Texas index. Moreover, 96% of patients exhibited signs of infection and were classified as Stage Texas B. Reoperation was necessary for 34.7% of patients. The mean hospital stay was 8.5 ± 7.55 days, and the average recovery time was 15.2 ± 15.19 days. Out of 75 patients, 10 were unable to return to limb function due to disability. In this study, around one-third of patients required secondary repair with grafts and flaps. A small number of them were unable to recover because of underlying disability, and the mean recovery time in other cases was 24 days. Future studies should follow up with patients for longer periods to assess long-term therapeutic outcomes and quality of life.

The effect of negative pressure wound therapy on the outcome of diabetic foot ulcers: A meta-analysis.

Negative pressure injury is one of the auxiliary methods of treating diabetes foot ulcers. It has been shown to be superior to conventional techniques in randomized controlled trials (RCTs). Nevertheless, the results of observational research are still scarce. A systematic review of RCTs and observations was carried out to evaluate the effectiveness and security of negative pressure wound therapy (NPWT) treatment for diabetes foot ulcers. Three English e-databases have been found for NPWT research. The meta-analyses of the comparative studies provided point estimates of results. Intermediate results were given as median and binary values were given in the form of odds ratios (OR). Seventeen trials, 13 RCTs and four randomized, controlled trials were found in the survey. Of these, 831 were treated with NPWT, 834 were treated with standard therapy. A total of 14 studies have been conducted to investigate the influence of NPWT on the healing of diabetic foot ulcers(DFU). In the study, NPWT was shown to speed up the healing of the wound in DFU patients(OR, 2.57; 95% CI, 1.72, 3.85 p < 0.0001). A subgroup analysis showed that NPWT was associated with an acceleration of the wound healing rate in 10 RCT trials (OR, 2.48; 95% CI, 1.58, 3.89 p < 0.001). In the four nRCT trials, NPWT was also shown to speed up the healing of the wound(OR, 2.95; 95% CI, 1.03, 8.42 p = 0.04). In 11 studies, the influence of NPWT on amputations of diabetes mellitus (DM) foot ulcers was investigated. The results showed that NPWT was associated with a reduction in amputations (OR, 0.53; 95% CI, 0.37, 0.74 p = 0.0002).In a subgroup of RCT trials, nine RCT trials showed a reduction in amputations(OR, 0.61; 95% CI, 0.43, 0.87 p = 0.007). In both nRCT trials, NPWT also showed a reduction in amputations (OR, 0.03; 95% CI, 0.00, 0.24 p = 0.001). Generally speaking, NPWT can help to heal the wound and lower the risk of amputations in people with diabetes. The subgroup analysis showed similar results for the RCT and non-RCT trials. NPWT can be used to treat diabetes foot ulcers caused by diabetes.

Foot and Ankle Care by Podiatrists and Amputations in Patients With Diabetes and Kidney Failure

Patients with kidney failure have an increased risk of diabetes-related foot complications. The benefit of regular foot and ankle care in this at-risk population is unknown. To investigate foot and ankle care by podiatrists and the outcomes of diabetic foot ulcers (DFUs) in patients with kidney failure. This retrospective cohort study included Medicare beneficiaries with type 2 diabetes receiving dialysis who had a new DFU diagnosis. The analysis of the calendar year 2016 to 2019 data from the United States Renal Data System was performed on June 15, 2023, with subsequent updates on December 11, 2023. Foot and ankle care by podiatrists during 3 months prior to DFU diagnosis. The outcomes were a composite of death and/or major amputation, as well as major amputation alone. Kaplan-Meier analysis was used to estimate 2 to 3 years of amputation-free survival. Foot and ankle care by podiatrists and the composite outcome was examined using inverse probability-weighted Cox regression, while competing risk regression models were used for the analysis of amputation alone. Among the 14 935 adult patients with kidney failure and a new DFU (mean [SD] age, 59.3 [12.7] years; 35.4% aged ≥65 years; 8284 men [55.4%]; Asian, 2.7%; Black/African American, 35.0%; Hispanic, 17.7%; White, 58.5%), 18.4% (n = 2736) received care by podiatrists in the 3 months before index DFU diagnosis. These patients were older, more likely to be male, and have more comorbidities than those without prior podiatrist visits. Over a mean (SD) 13.5 (12.0)-month follow-up, 70% of those with podiatric care experienced death and/or major amputation, compared with 74% in the nonpodiatric group. Survival probabilities at 36 months were 26.3% vs 22.8% (P < .001, unadjusted Kaplan-Meier survival analysis). In multivariate regression analysis, foot and ankle care was associated with an 11% lower likelihood of death and/or amputation (hazard ratio [HR], 0.89 95% CI, 0.84-0.93) and a 9% lower likelihood of major amputation (above or below knee) (HR, 0.91; 95% CI, 0.84-0.99) than those who did not. The findings of this study suggest that patients with kidney failure at risk for DFUs who receive foot and ankle care from podiatrists may be associated with a reduced likelihood of diabetes-related amputations.

Short-term glucose variability as a determinant of the healing rate of diabetic foot ulcer: A retrospective study

BackgroundThe aim of this study was to describe the clinical characteristics of people with diabetic foot ulcer (DFU) according to glucose variability (GV) and to investigate the relationship between GV and DFU outcome in a population with type 2 diabetes (T2D) and DFU. MethodsThis is a retrospective study of 300 individuals aged 64.3 years (181 males) treated for DFU in a tertiary-care center with a regular follow-up for 6 months. Laboratory measurements and clinical assessments were collected at baseline. According to the coefficient of variation (CV) cut-off (≥36%), people were divided into two groups (low and high GV). ResultsCompared with low GV group (n = 245), high GV group (n = 55) had significant longer duration of diabetes [low vs high GV, mean ± Standard Deviation (SD), 17.8 ± 11.8 vs 22.4 ± 10.8, P = 0.012], higher levels of glycated haemoglobin [median (IQR), 7.4 (6.6, 8.8) vs 8.2 (7.0, 9.6), P = 0.010] and urinary albumin excretion [25.2 (11.9, 77.0) vs 48.0 (23.2, 106.0), P = 0.031]. Moreover, 10 days self-monitoring of blood glucose-derived glycemic metrics were significantly different between groups. No differences among clinical features were found. The multiple logistic regression analysis identified CV and SD as negative predictors of healing. ConclusionsIn a population of people with T2D and DFU treated in a tertiary-care center, individuals with high GV had a 3-fold higher risk of healing failure, as compared with those with low GV. CV and SD were related to poor healing within 6 months follow-up.

The Association of the Neutrophil-Lymphocyte Ratio With Diabetes Mellitus and Diabetic Foot Ulcer: A Review Article

Introduction: Diabetes mellitus (DM) is inappropriately elevated blood glucose levels. Diabetic foot ulcer (DFU) is the most common complication of diabetes mellitus. Many research studies was found that neutrophil lymphocyte ratio (NLR) have positive correlation with HBA1C, blood glucose, and outcome of diabetic foot ulcer. Methods: The literature searches using online databases such as PubMed, ScienceDirect Elsevier, and Google Schoolar. Result: After doing an online search, we found 39 articles were relevant for this review topic. Analysis: Many research studies have found increased HbA1C (≥6,5) and increased blood glucose (random blood glucose ≥ 200mg/dL and/or fasting blood glucose ≥126 mg/dL) in patients with diabetes mellitus have a positive correlation with increased NLR. And there was increased NLR values in patients with diabetic foot ulcer and NLR values was higher (NLR≥6) in non-healing ulcers than in healing ulcers. Conclusion: NLR can be used as screening tool for determining evaluation of diabetes mellitus and as screening tool for determining outcome of diabetic foot ulcers.

ASSOCIATION OF LEVEL OF EDUCATION AND OCCUPATION WITH DIABETIC FOOT ULCER IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

Objective: Diabetic foot ulcer (DFU) is a well-known microvascular complication of Type 2 Diabetes mellitus (T2DM) with several risk factors. This study intended to determine the association of the level of education and occupation with the severity and outcome of DFU in diabetic patients. Materials and Methods: This study was conducted from 1st January 2023 to 25th January 2023 in the Endocrinology Division of the Department of Medical Specialties, Khyber Teaching Hospital, Peshawar. Adult diabetic patients with DFU were enrolled in the study. All the relevant demographic, clinical, and biochemical characteristics were measured. Results: Out of 148 patients, only 50 (33.8%) patients were educated. The study participants had a mean age, BMI, HbA1c, and duration of DM of 56.48 years, 27.3 kg/m2, 10.3 % and 9.4 years, respectively. There was a substantial association between the level of education and occupation with the severity of DFU which was statistically significant (p-value = 0.001 and p-value = 0.01, respectively). Regarding the outcome of DFU, it was found that patients with medium and high levels of literacy and skilled occupation had lower rates of major amputations. These results were statistically non-significant however they were found to be clinically significant. Conclusion: A significant association was observed between the education level and occupation with the severity and outcome of DFU. This underpins the significance of structured education of patients with low and medium literacy levels and those with unskilled and semiskilled jobs regarding their foot care. Keywords: Type 2 Diabetes Mellitus, Diabetic Foot ulcer, Occupation

A Cohort Study on the Outcome of Diabetic Foot Ulcers.

Diabetic foot ulcers (DFUs) represent a significant and challenging complication of diabetes mellitus, often leading to serious morbidity and a substantial burden on healthcare systems. The study was conducted with the objectives of evaluating the outcomes of DFUs. A cohort study was conducted to evaluate the outcomes of DFUs from May 2019 to May 2020 at a tertiary care hospital located in Chennai. The study included patients aged 18 to 90 yearswho were diagnosed with DFUs. Individuals with diabetic foot lesions (skin lesions such as fissures, abscess, cellulites) other than ulcers or those without diabetes were excluded. The data was collected from a total of 100 diabetic patients using systematic random sampling technique. The mean (SD) age of the study participants was 54.68 (6.72) years with males constituting 56% of the study population. Among 100 participants, 65% experienced healing while 35% did not. Logistic regression analysis showed that glycated haemoglobin (HbA1c) levels, age, and diabetes duration had significant effect on patient outcome. Logistic regression analysis showed that HbA1c levels, age, and diabetes duration had significant effect on patient outcome. Out of 12 patients with major amputation, seven (58.3%) survived, while out of 19 patients with minor amputations, 18 (94.7%) showed remarkably higher survival rate. Meanwhile, 100% survival rate was observed in patients with no amputation. The study's comprehensive assessment of risk factors and their associations with healing outcomes provides essential knowledge for clinical practice. The study findings collectively support the optimization of interventions and strategies to prevent and manage DFUs, ultimately improving patient care and enhancing their quality of life. The study highlights the significance of glycemic control and limb preservation in DFU management.

Growth factors and their receptors in neuropathic diabetic foot ulcers of different durations

BACKGROUND. Growth factors play a leading role in wound healing. Their deficiency in diabetic foot syndrome has been demonstrated in experimental studies, most of them performed on acute wounds. At the same time, currently the effectiveness of local therapy with growth factors of this category of patients, as well as indications and contraindications to it are contradictory and are a subject for discussion. There is no data on the content of growth factors in diabetic foot ulcers of various durations. Meanwhile, the results obtained will help to expand the understanding of the pathogenetic mechanisms of the course and outcomes of diabetic foot ulcers at different stages of healing.AIM: To evaluate the level of growth factors and their receptors in non-healing neuropathic diabetic foot ulcers of different duration.MATERIALS AND METHODS. 89 samples of neuropathic diabetic foot ulcers were examined. Immunohistochemical analysis of biopsies was performed using antibodies to the following growth factors and their receptors: vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), epidermal growth factor (EGF). Depending on the duration of the wound, the biopsies were divided into 3 groups: group 1 — ≤ 90 days, group 2 — 91-365 days, group 3 — &gt; 365 days.RESULTS. In the samples of wounds, the duration of which did not exceed 90 days, the expression of growth factors and receptors to them was significantly higher than in wounds of longer duration (p=0.0001). There was no significant difference in quantitative indicators of the expression of growth factors and their receptors between wounds lasting from 91 to 365 days and more than 365 days. According to the data of correlation analysis, the expression of VEGF, IGF, EGF and their receptors has a significant negative dependence on the duration of the wound (p= 0.0001).CONCLUSION. In diabetic foot ulcers lasting less than 90 days, the expression of growth factors such as VEGF, IGF, EGF and their receptors is significantly higher than in wounds of longer duration. The dependence of the expression of growth factors on the duration of the ulcer was revealed. The data obtained may explain the differences in the outcomes of chronic wounds and the absence in some cases of the effect of local therapy with growth factors.

The model and efficacy of online nurse-led on the clinical outcome of diabetic foot ulcers: an integrative systematic review and meta-analysis of randomized controlled trials

The model and efficacy of online nurse-led on the clinical outcome of diabetic foot ulcers: an integrative systematic review and meta-analysis of randomized controlled trials

Microbial Prevalence and Outcome of Diabetic Foot Ulcers in Patient’s Candidates for Minor Surgical Interventions

Background: Diabetes mellitus is a progressive disease with chronic complications such as diabetic foot infection, a significant difficulty that inevitably leads to gangrene and amputations.&#x0D; &#x0D; Objective: This study aims to determine microbial prevalence in diabetic foot infections, identify the significance of aggressive surgical therapy and minor amputations in limb salvage and the prevention of more proximal amputations, and identify predicting factors affecting the outcome of these surgical processes.&#x0D; &#x0D; Methods: In this cohort study, microbiological samples were collected from 62 patients with diabetic foot lesions who underwent debridement or minor amputations to determine the prevalence of microorganisms in diabetic foot infections. Then, they were followed up to determine the rate of saved limbs and the factors that affect the outcomes and rate of complications.&#x0D; &#x0D; Results: infections were mainly caused by aerobic Gram-positive bacteria (S. aureus) 53.5%, and aerobic Gram-negative bacteria of enterobacter species 40.4%. Regarding the outcome of surgical intervention, we found an 80.65% success rate of saving the limb with a 30.6% complication rate. Risk factors such as high levels of inflammatory markers and parameters of the severity of peripheral arterial disease showed significant association with the rate of complications and poor outcomes.&#x0D; &#x0D; Conclusions: Debridement and minor surgical amputations effectively prevent more proximal amputations in diabetic foot infections with a high chance of good results. At the same time, the common microorganism in our local population was S. aureus, followed by P. mirabilis, E. coli, and Klebsiella species in diabetic foot infections.

100-OR: A Novel Macrophage-Regulation Drug for Treating Diabetic Foot Ulcer—A Phase III MRCT Study and Taiwan Experience

Macrophage regulation plays an essential role in Diabetic foot ulcer (DFU) healing. By recognizing the therapeutic potential in M1/M2-macrophage-regulation for DFUs, we aim to investigate the efficacy and safety of ON101, a topical new drug with a M1/M2-macrophage-regulating mechanism in phase 3 MRCT across the US, China, and Taiwan (NCT01898923). There are 236 eligible subjects with Wagner Grade 1 or 2 DFU(s), randomized 1:1 to receive ON101 or comparator for up to 16 weeks, followed by a 12-week follow-up. The incidence of complete healing was 60.7% by ON101 and 35.1% by the comparator (P=0.0001). The time to complete ulcer healing was faster in the ON101 group (P=0.002). Since the high levels of HbA1C, ulcer persistence, ulcer location, and amputation history as the risk factors leading to poor DFU outcomes, ON101 also showed demonstrated robust efficacy and safety in hard-to-heal ulcers. ON101, approved by Taiwan FDA in 2021, was shown with excellent therapeutic efficacy and safety in the treatment of DFUs. In a real-world scenario, case collation from 133 patients, ulcer severity with Wagner grade 1 to 4, after applying ON101, the average ulcer complete healing rate is 71%, no adverse events were related to ON101, which validates the drug safety of ON101. ON101 further supports its excellent ability to promote wound healing in DFU patients with various severities (Wagner grade 1 to 4). All those patients who applied ON101 alone or with other therapies reached ulcer healing under infection control and with necessary debridement. Macrophage-regulating drug achieved superior therapeutic efficacy in a large Phase 3 MRCT and has demonstrated excellent therapeutic efficacy in the real-world scenario where Wagner grade 3 and 4 DFUs reached ulcer healing when ON101 was combined with other therapies. This enlightens the future treatment in Wagner grade 1 to 4 DFUs by macrophage immunomodulation new drug as a promising solution. Disclosure S.Chen: Employee; Oneness Biotech Co., Ltd. S.Chu: None. C.Pu: None. J.Chen: Employee; Oneness Biotech Company. Y.Wu: Employee; Oneness Biotech Co., Ltd.

Abstract #1401721: The Effect of the Different Waves of COVID-19 Pandemic on the Outcome of Diabetic Foot Ulcers

Diabetic foot ulcers (DFUs) are complications of diabetes mellitus. COVID-19 pandemic has massively impacted human health. We studied effect of COVID-19 on outcome of DFUs. We recruited 483 people with DFU from June 2020-April 2022 (pandemic group) together with a matched group of 227 people with DFU from March 2019-March 2020 (pre-pandemic group). Matching was done with respect to glycemic control (Average HbA1c in pandemic group 9.15%; pre-pandemic group 8.92%), and renal status. Primary endpoint was outcome of ulcers- healed or undergone amputation. Primary outcome was further sub analyzed in the 3 waves of COVID-19 Secondary endpoint was healing of individual types of DFUs. Basic anthropometric data with site, nature and Wegner’s grading of DFUs were collected. Diagnosis of peripheral neuropathy was done by monofilament testing and peripheral arterial disease by handheld Doppler and ABI. Standardized treatment protocol including glycemic control, infection control, debridement, dressing, offloading was provided. All patients were monitored for >6 months. In pandemic cohort of 483 patients 323(66.9%) patients had healed ulcers, 70(14.5%) had minor amputation, 11(2,2%) had major amputation, 29(6%) lost to follow up, 22(4.6%) had not healed and 28 are in follow up (5.8%). Rate of healing of DFU in pandemic group was higher (66.9%) than control group (53.5%). Similarly, rate of amputation in pandemic group was less (16.7%) than pre-pandemic group (23.4%). Among healed ulcers in pandemic group, non-infected neuropathic ulcers healed better (77.8%; 199/256) than other types (54.6%; 124/227) [p< 0.00001]. Similarly, rate of amputation (major/minor) in ischemic and neuroischemic ulcers in pandemic group was more (32.3%; 11/34) than other types (15.6%; 70/449) [p= 0.011]. Rate of healing of foot ulcers in 1st wave was 65.4% (53/81), 2nd wave 75.2% (158/210), 3rd wave 58.3% (112/192). Neuropathic ulcers though less prevalent in first two waves (49.8%; 145/291) than 3rd wave (57.8%; 111/192) healing rate was more in first two (79.3%; 115/145 vs 75.6%; 84/111). [p=0.488 (statistically not significant]. Ischemic and neuroischemic ulcers were more in 3rd wave (7.8%; 15/192) than first two waves (6.5%; 19/291) and undergone more amputation (46.7%; 7/15 vs 15.7%; 3/19). [p=0.58 (statistically not significant; due to small sample size]. COVID-19 pandemic (mainly first two waves) accounted for travel restrictions contributing to better healing of neuropathic ulcers whereas ischemic and neuroischemic ulcers worsened and underwent more amputation as patients could not seek intervention. Conversely, in third wave withdrawal of COVID restrictions lead to worsening of DFUs leading to less healing and more amputation.

The Association of the Neutrophil-Lymphocyte Ratio With the Outcome of Diabetic Foot Ulcer.

Introduction One of the most common lower-extremity impediments in people suffering from diabetes mellitus (DM) is foot ulceration. Neutrophil-lymphocyte ratio (NLR) is a useful measure in predicting disease-specific morbidity and mortality. Objectives The objective is to study the association between diabetic foot ulcer healing and the NLR. Methodology A prospective analytical study was conducted among 100 patients with diabetic foot ulcers admitted to a surgical ward in a teaching hospital between April and November 2022. Basic demographic details, ulcer examination, and NLR were evaluated on the day of admission, and the status of ulcers was assessed after six weeks and the outcome was compared with the NLR value. Data analysis was done using SPSS version 20 software (SPSS, Inc., Chicago, IL). Results The average neutrophils, lymphocytes, and neutrophil-lymphocyte ratio were, respectively, 94.73%, 14.97%, and 6.65%. 58% had healing ulcers, and 42% had non-healing ulcers. 44% of study subjects had NLR <6, which is normal, and 56% had NLR >6, which is abnormal. Among 58 subjects with healing ulcers, 75.9% had NLR < 6, and among 42 subjects with non-healing ulcers, 100% had NLR >6, which was statistically significant. The mean NLR in the healing group was 5.15 and in the non-healing group was 8.205; this was statistically significant. This shows an increased NLR has a predisposition towards non-healing chronic ulcers with a poor prognosis. Conclusion NLR can be used as a reliable indicator for determining the healing status of diabetic foot ulcers.