Research

17 pages, 2180 KiB

Open AccessArticle

Evaluation of Adjuvant Antibiotic Loaded Injectable Bio-Composite Material in Diabetic Foot Osteomyelitis and Charcot Foot Reconstruction

by Venu Kavarthapu, Jasdeep Giddie, Varun Kommalapati, Joanne Casey, Maureen Bates and Prashanth Vas

J. Clin. Med. 2023, 12(9), 3239; https://doi.org/10.3390/jcm12093239 - 01 May 2023

Cited by 1 | Viewed by 1884

Abstract

The management of diabetic foot osteomyelitis (DFO) is extremely challenging with high amputation rates reported alongside a five-year mortality risk of more than fifty percent. We describe our experience in using adjuvant antibiotic-loaded bio-composite material (Cerament) in the surgical management of DFO and [...] Read more.

The management of diabetic foot osteomyelitis (DFO) is extremely challenging with high amputation rates reported alongside a five-year mortality risk of more than fifty percent. We describe our experience in using adjuvant antibiotic-loaded bio-composite material (Cerament) in the surgical management of DFO and infected Charcot foot reconstruction. We undertook a retrospective evaluation of 53 consecutive patients (54 feet) who underwent Gentamicin or Vancomycin-loaded Cerament application during surgery. The feet were categorised into two groups: Group 1, with infected ulcer and DFO, managed with radical debridement only (n = 17), and Group 2, requiring reconstruction surgery for infected and deformed Charcot foot. Group 2 was further subdivided into 2a, with feet previously cleared of infection and undergoing a single-stage reconstruction (n = 19), and 2b, with feet having an active infection managed with a two-stage reconstruction (n = 18). The mean age was 56 years (27–83) and 59% (31/53) were males. The mean BMI was 30.2 kg/m² (20.8–45.5). Foot ulcers were present in 69% (37/54) feet. At a mean follow-up of 30 months (12–98), there were two patients lost to follow up and the mortality rate was 11% (n = 5). The mean duration of post-operative systemic antibiotic administration was 20 days (4–42). Thirteen out of fifteen feet (87%) in group 1 achieved complete eradication of infection. There was a 100% primary ulcer resolution, 100% limb salvage and 76% bony union rate within Group 2. However, five patients, all in group 2, required reoperations due to problems with bone union. The use of antibiotic-loaded Cerament resulted in a high proportion of patients achieving infection clearance, functional limb salvage and decrease in the duration of postoperative antibiotic therapy. Larger, preferably randomised, studies are required to further validate these observations. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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9 pages, 439 KiB

Open AccessArticle

Risk Factors for Surgical Site Infections in Elective Orthopedic Foot and Ankle Surgery: The Role of Diabetes Mellitus

by Laura Soldevila-Boixader, Arnd Viehöfer, Stephan Wirth, Felix Waibel, Inci Yildiz, Mike Stock, Peter Jans and Ilker Uçkay

J. Clin. Med. 2023, 12(4), 1608; https://doi.org/10.3390/jcm12041608 - 17 Feb 2023

Cited by 1 | Viewed by 1699

Abstract

Surgical site infection (SSI) after elective orthopedic foot and ankle surgery is uncommon and may be higher in selected patient groups. Our main aim was to investigate the risk factors for SSI in elective orthopedic foot surgery and the microbiological results of SSI [...] Read more.

Surgical site infection (SSI) after elective orthopedic foot and ankle surgery is uncommon and may be higher in selected patient groups. Our main aim was to investigate the risk factors for SSI in elective orthopedic foot surgery and the microbiological results of SSI in diabetic and non-diabetic patients, in a tertiary foot center between 2014 and 2022. Overall, 6138 elective surgeries were performed with an SSI risk of 1.88%. The main independent associations with SSI in a multivariate logistic regression analysis were an ASA score of 3–4 points, odds ratio (OR) 1.87 (95% confidence interval (CI) 1.20–2.90), internal, OR 2.33 (95% CI 1.56–3.49), and external material, OR 3.08 (95% CI 1.56–6.07), and more than two previous surgeries, OR 2.86 (95% CI 1.93–4.22). Diabetes mellitus showed an increased risk in the univariate analysis, OR 3.94 (95% CI 2.59–5.99), and in the group comparisons (three-fold risk). In the subgroup of diabetic foot patients, a pre-existing diabetic foot ulcer increased the risk for SSI, OR 2.99 (95% CI 1.21–7.41), compared to non-ulcered diabetic patients. In general, gram-positive cocci were the predominant pathogens in SSI. In contrast, polymicrobial infections with gram-negative bacilli were more common in contaminated foot surgeries. In the latter group, the perioperative antibiotic prophylaxis by second-generation cephalosporins did not cover 31% of future SSI pathogens. Additionally, selected groups of patients revealed differences in the microbiology of the SSI. Prospective studies are required to determine the importance of these findings for optimal perioperative antibiotic prophylactic measures. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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8 pages, 267 KiB

Open AccessArticle

Microcirculation Improvement in Diabetic Foot Patients after Treatment with Sucrose Octasulfate-Impregnated Dressings

by José Luis Lázaro-Martínez, Marta García-Madrid, Serge Bohbot, Mateo López-Moral, Francisco Javier Álvaro-Afonso and Yolanda García-Álvarez

J. Clin. Med. 2023, 12(3), 1040; https://doi.org/10.3390/jcm12031040 - 29 Jan 2023

Cited by 3 | Viewed by 1790

Abstract

To assess the patients’ microcirculation evolution during the treatment with a sucrose octasulfate-impregnated dressing, fifty patients with neuroischaemic DFU treated with TLC-NOSF dressing were included in a prospective study between November 2020 and February 2022. TcpO₂ values were measured on the dorsalis [...] Read more.

To assess the patients’ microcirculation evolution during the treatment with a sucrose octasulfate-impregnated dressing, fifty patients with neuroischaemic DFU treated with TLC-NOSF dressing were included in a prospective study between November 2020 and February 2022. TcpO₂ values were measured on the dorsalis pedis or tibial posterior arteries’ angiosome according to the ulcer location. TcpO₂ values were assessed at day 0 and every 4 weeks during 20 weeks of the follow-up or until the wound healed. A cut-off point of tcpO₂ < 30 mmHg was defined for patients with impaired microcirculation. The TcpO₂ values showed an increase between day 0 and the end of the study, 33.04 ± 12.27 mmHg and 40.89 ± 13.06 mmHg, respectively, p < 0.001. Patients with impaired microcirculation showed an increase in the tcpO₂ values from day 0 to the end of the study (p = 0.023). Furthermore, we observed a significant increase in the TcpO₂ values in the forefoot DFU (p = 0.002) and in the rearfoot DFU (p = 0.071), with no difference between the ulcer locations (p = 0.694). The local treatment with TLC-NOSF dressing improved the microcirculation in patients with neuroischaemic DFU, regardless of microcirculation status at the baseline, and in the forefoot, regardless of the location. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

10 pages, 1244 KiB

Open AccessArticle

Re-Epithelialization of Neuropathic Diabetic Foot Wounds with the Use of Cryopreserved Allografts of Human Epidermal Keratinocyte Cultures (Epifast)

by Fermin R. Martinez-De Jesús, Robert Frykberg, Elízabeth Zambrano-Loaiza and Edward B. Jude

J. Clin. Med. 2022, 11(24), 7348; https://doi.org/10.3390/jcm11247348 - 10 Dec 2022

Viewed by 1651

Abstract

The application of tissue-engineering technology to wound healing has become an option for the treatment of diabetic foot ulcers (DFU). A comparative, prospective study was conducted to assess the efficacy of a cryopreserved allograft of human epidermal keratinocytes (Epifast) to enhance wound healing [...] Read more.

The application of tissue-engineering technology to wound healing has become an option for the treatment of diabetic foot ulcers (DFU). A comparative, prospective study was conducted to assess the efficacy of a cryopreserved allograft of human epidermal keratinocytes (Epifast) to enhance wound healing in granulating DFU. Eighty patients were assigned to receive Epifast (n = 40) or Standard Care (SC) treatment (n = 40). The Epifast group displayed a shorter duration of the epithelialization phase (3.5 ± 4 vs. 6.4 ± 3.6 weeks, p < 0.05) and upon the entire wound healing process than the SC group (10 ± 5.7 vs. 14.5 ± 8.9 weeks, p < 0.05), reaching wound closure at 16 and 30 weeks, respectively. The Kaplan–Meier analysis revealed that Epifast group patients were 50% more likely than the SC to heal wounds faster (Cox-hazards ratio of 0.5, 95% CI = 0.3–0.8, p < 0.0001; Likelihood Ratio of 7.8. p < 0.05). Patients in the control group displayed a slower healing as the Saint Elian (SEWSS) severity grade increased (group differences of 0.6, 3.8, and 4.3 weeks for grades I, II, and III, respectively). DFW treated with Epifast displayed a shorter time to complete re-epithelialization than wounds treated with standard care. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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11 pages, 603 KiB

Open AccessArticle

Validation of the Ischaemia Severity Scale (ISS) Based on Non-Invasive Vascular Assessments (SEWSS) for Predicting Outcomes of Diabetic Foot Attack

by Fermín Rafael Martinez-De Jesús, Emmanuel Hernandez-Luevano, Neftalí Rodriguez-Ramírez, Rafael Cendejas-Alatorre, José Antonio Muñoa Prado, Favio Carrera Maigua and Elízabeth Zambrano-Loaiza

J. Clin. Med. 2022, 11(23), 7195; https://doi.org/10.3390/jcm11237195 - 03 Dec 2022

Cited by 2 | Viewed by 1710

Abstract

Assessment of ischaemia severity includes a variety of measures, such as pedal pulse palpation, the ankle/brachial index (ABI), and the toe/brachial index (TBI), but there is a lack of consensus regarding which ischaemia scale is the most effective for determining outcome prognosis. The [...] Read more.

Assessment of ischaemia severity includes a variety of measures, such as pedal pulse palpation, the ankle/brachial index (ABI), and the toe/brachial index (TBI), but there is a lack of consensus regarding which ischaemia scale is the most effective for determining outcome prognosis. The purpose of this study is to validate the application of the ischaemia severity scale (ISS) in the effective prediction of wound healing, amputations, and mortality for diabetic foot wounds (DFW). This prospective study included 235 consecutive patients graded according to the Saint Elian Wound Score System (SEWSS). The ISS is part of this system, with patients being scored as non-ischaemic (0) or having mild (1), moderate (2), or severe (3) ischaemia. Age, diabetes duration in years, and ulcer size were found to be associated with a longer mean ischaemia of increasing severity. A trend of reduction in the pulse palpation rates (70.4%, 50%, 8.5% to 0%; p < 0.01), ABI (1.1 ± 0.1, 0.86 ± 0.3, 0.68 ± 0.2, 0.47 ± 0.2, p < 0.01), TBI average values (0.90 ± 0.35, 0.62 ± 0.52, 0.50 ± 0.33, 0.10 ± 0.42, p < 0.01), wound healing success (88.7%, 57.7%, 40.7%, 12.9%; p < 0.01), and delay in weeks (Kaplan–Meier: log-rank 44.2, p < 0.01) was observed with increasing values of the ISS (0, 1, 2, and 3). The odds ratio for adverse outcomes increased for each additional level of ischaemia severity. Thus, we demonstrate that the ISS is useful in effectively predicting adverse outcomes for DFW. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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8 pages, 1296 KiB

Open AccessArticle

Mortality Risk Associated with Diabetic Foot Complications in People with or without History of Diabetic Foot Hospitalizations

by Piergiorgio Francia, Elisa Gualdani, Laura Policardo, Leonardo Bocchi, Flavia Franconi, Paolo Francesconi and Giuseppe Seghieri

J. Clin. Med. 2022, 11(9), 2454; https://doi.org/10.3390/jcm11092454 - 27 Apr 2022

Cited by 1 | Viewed by 1302

Abstract

The aim of this study was to evaluate the risk of death after hospitalizations for diabetic foot (DF) complications, comparing two different cohorts of people with or without a prior history of DF hospitalizations across the years 2011 to 2018 in Tuscany, Italy. [...] Read more.

The aim of this study was to evaluate the risk of death after hospitalizations for diabetic foot (DF) complications, comparing two different cohorts of people with or without a prior history of DF hospitalizations across the years 2011 to 2018 in Tuscany, Italy. The DF complications were categorized by administrative source datasets such as: amputations (both major and minor), gangrene, ulcers, infections, Charcot and revascularizations. A further aim was to present the trend over time of the first ever incidents of diabetic foot hospitalizations in Tuscany. The eight-year-mortality rate was higher in the cohort with prior hospitalizations (n = 6633; 59%) compared with the cohort with first incident DF hospitalizations (n = 5028; 44%). Amputations (especially major ones) and ulcers had the worst effect on survival in people without basal history of DF hospitalizations and respectively in those with a history of prior DF hospitalizations. In both cohorts, revascularization procedures, when compared to ulcers, were associated with a significantly reduced risk of mortality. The prevalence rate of minor amputations showed a slightly rising trend over time. This result agrees with the national trend. Conversely, the progressive increase over time of revascularizations, associated with the fractional decrease in the rate of gangrene, suggests a trend for more proactive behavior by DF care teams in Tuscany. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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9 pages, 249 KiB

Open AccessArticle

Nutritional Status Assessed with Objective Data Assessment Correlates with a High-Risk Foot in Patients with Type 2 Diabetes

by Yusuke Mineoka, Michiyo Ishii, Yoshitaka Hashimoto, Aki Yamashita, Takahiro Takemura, Sachiyo Yamaguchi, Machiko Toyoda and Michiaki Fukui

J. Clin. Med. 2022, 11(5), 1314; https://doi.org/10.3390/jcm11051314 - 27 Feb 2022

Cited by 6 | Viewed by 1722

Abstract

Malnutrition and diabetes are likely to co-occur. There are few reports on the association between nutritional status and foot risk in patients with type 2 diabetes (T2D). Therefore, we aimed to investigate this relationship in this cross-sectional study. We investigated the relationships between [...] Read more.

Malnutrition and diabetes are likely to co-occur. There are few reports on the association between nutritional status and foot risk in patients with type 2 diabetes (T2D). Therefore, we aimed to investigate this relationship in this cross-sectional study. We investigated the relationships between objective data assessment (ODA), especially Controlling Nutritional Status (CONUT) score and foot risk, evaluated by the International Working Group on the Diabetic Foot (IWGDF), in consecutive patients with T2D. Patients were divided into groups 0 to 3 by IWGDF, and groups 1 to 3 were defined as high-risk groups. Among 469 patients, 42.6% (n = 200) of them had high-risk foot. Patients with high-risk foot were significantly older (71.2 ± 11.3 vs. 64.2 ± 13.4 years, p < 0.001) and had a longer duration of diabetes (18.0 ± 12.0 vs. 11.5 ± 10.0 years, p < 0.001) than those in the low-risk group. In the high-risk group, serum albumin level, total lymphocyte count, hemoglobin, and CONUT score were significantly worse, especially in older patients (≥75 years). Multivariate logistic regression analysis showed that there was a positive correlation between CONUT score and high-risk foot in older patients (OR, 1.37; 95% CI, 1.05–1.86; p = 0.021). Our results indicated that nutritional status, assessed by ODA, correlated with high-risk foot, especially in older patients with T2D. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

11 pages, 1272 KiB

Open AccessArticle

Evaluation of the Use of Antibiofilmogram Technology in the Clinical Evolution of Foot Ulcers Infected by Staphylococcus aureus in Persons Living with Diabetes: A Pilot Study

by Albert Sotto, Frédéric Laurent, Sophie Schuldiner, Julien Vouillarmet, Stéphane Corvec, Pascale Bemer, David Boutoille, Catherine Dunyach-Rémy and Jean-Philippe Lavigne

J. Clin. Med. 2021, 10(24), 5928; https://doi.org/10.3390/jcm10245928 - 17 Dec 2021

Cited by 3 | Viewed by 2261

Abstract

Infected diabetic foot ulcers (DFUs) represent a serious threat to public health because of their frequency and the severity of their consequences. DFUs are frequently infected by bacteria in biofilms, obstructing antibiotic action. Antibiofilmogram was developed to assess the impact of antibiotics to [...] Read more.

Infected diabetic foot ulcers (DFUs) represent a serious threat to public health because of their frequency and the severity of their consequences. DFUs are frequently infected by bacteria in biofilms, obstructing antibiotic action. Antibiofilmogram was developed to assess the impact of antibiotics to inhibit biofilm formation. This pilot study aimed to determine the benefits of this technology in predicting antibiotic activity on the outcome of 28 patients with Grade 2 DFUs that were infected by a monomicrobial Staphylococcus aureus. Patients with diabetes were followed during the antibiotic treatment (day 14) and the follow-up period of the study (day 45). The contribution of Antibiofilmogram was compared between patients with non-concordant results (n = 13) between antibiogram and Antibiofilmogram versus concordant results (n = 15). The clinical improvement of wounds (80.0% vs. 38.5%, p = 0.0245) and the absence of exudates (0% vs. 33.3%, p = 0.0282) were observed in concordant vs. discordant groups. This pilot study provides promising results for the interest of Antibiofilmogram in the prescription of antibiotics to prevent biofilm formation in infected DFUs. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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11 pages, 5104 KiB

Open AccessArticle

Psychometric Validation of the Cardiff Wound Impact Schedule Questionnaire in a Spanish Population with Diabetic Foot Ulcer

by Minerva Granado-Casas, Dolores Martinez-Gonzalez, Montserrat Martínez-Alonso, Montserrat Dòria, Nuria Alcubierre, Joan Valls, Josep Julve, José Verdú-Soriano and Didac Mauricio

J. Clin. Med. 2021, 10(17), 4023; https://doi.org/10.3390/jcm10174023 - 06 Sep 2021

Cited by 3 | Viewed by 2321

Abstract

Diabetic foot ulcers (DFU) negatively affect the quality of life (QoL) of people with diabetes. The Cardiff Wound Impact Schedule (CWIS) questionnaire has been designed to measure the QoL of people with chronic foot wounds. However, no studies have been specifically designed to [...] Read more.

Diabetic foot ulcers (DFU) negatively affect the quality of life (QoL) of people with diabetes. The Cardiff Wound Impact Schedule (CWIS) questionnaire has been designed to measure the QoL of people with chronic foot wounds. However, no studies have been specifically designed to validate this instrument in a Spanish population. In this prospective study, a total of 141 subjects with DFU were recruited. DFU was determined by performing physical examinations. Medical records were exhaustively reviewed to collect clinical variables. The CWIS was transculturally adapted by a group of experts and a group of patients with DFU. The SF-36 and EQ-5D generic instruments were used as reference tools. The questionnaires were administered at 7 days and 4, 12, and 26 weeks after the baseline assessment by personal interview with each of the study subjects. The psychometric properties of the instrument were assessed using statistical methods. The content validity had an average of 3.63 (90.7% of the maximum score of 4). The internal consistency of the CWIS subscales had a standardized Cronbach’s alpha range from 0.715 to 0.797. The reproducibility was moderate with an intraclass correlation coefficient (ICC) range from 0.606 to 0.868. Significant correlations between CWIS domains and SF-36 and EQ-5D subscales were observed, demonstrating a good criterion validity of the CWIS questionnaire (p < 0.001). However, the construct validity of the CWIS was not validated with a comparative fit index (CFI) of 0.69, a root mean square error of approximation (RMSEA) of 0.09, and a standardized root mean square residual (SRMR) of 0.10. The sensitivity to changes over time was optimal in the three domains (i.e., social life, well-being, and physical symptoms) (p < 0.001). In conclusion, the Spanish version of the CWIS shows acceptable psychometric properties to assess the QoL of subjects with DFU, except for its construct validity. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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12 pages, 1114 KiB

Open AccessArticle

The Association between Foot and Ulcer Microcirculation Measured with Laser Speckle Contrast Imaging and Healing of Diabetic Foot Ulcers

by Onno A. Mennes, Jaap J. van Netten, Jeff G. van Baal, Riemer H. J. A. Slart and Wiendelt Steenbergen

J. Clin. Med. 2021, 10(17), 3844; https://doi.org/10.3390/jcm10173844 - 27 Aug 2021

Cited by 12 | Viewed by 2326

Abstract

Diagnosis of peripheral artery disease in people with diabetes and a foot ulcer using current non-invasive blood pressure measurements is challenging. Laser speckle contrast imaging (LSCI) is a promising non-invasive technique to measure cutaneous microcirculation. This study investigated the association between microcirculation (measured [...] Read more.

Diagnosis of peripheral artery disease in people with diabetes and a foot ulcer using current non-invasive blood pressure measurements is challenging. Laser speckle contrast imaging (LSCI) is a promising non-invasive technique to measure cutaneous microcirculation. This study investigated the association between microcirculation (measured with both LSCI and non-invasive blood pressure measurement) and healing of diabetic foot ulcers 12 and 26 weeks after measurement. We included sixty-one patients with a diabetic foot ulcer in this prospective, single-center, observational cohort-study. LSCI scans of the foot, ulcer, and ulcer edge were conducted, during baseline and post-occlusion hyperemia. Non-invasive blood pressure measurement included arm, foot, and toe pressures and associated indices. Healing was defined as complete re-epithelialization and scored at 12 and 26 weeks. We found no significant difference between patients with healed or non-healed foot ulcers for both types of measurements (p = 0.135–0.989). ROC curves demonstrated moderate sensitivity (range of 0.636–0.971) and specificity (range of 0.464–0.889), for LSCI and non-invasive blood pressure measurements. Therefore, no association between diabetic foot ulcer healing and LSCI-measured microcirculation or non-invasive blood pressure measurements was found. The healing tendency of diabetic foot ulcers is difficult to predict based on single measurements using current blood pressure measurements or LSCI. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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12 pages, 1112 KiB

Open AccessArticle

Autologous Peripheral Blood Mononuclear Cells for Limb Salvage in Diabetic Foot Patients with No-Option Critical Limb Ischemia

by Alessia Scatena, Pasquale Petruzzi, Filippo Maioli, Francesca Lucaroni, Cristina Ambrosone, Giorgio Ventoruzzo, Francesco Liistro, Danilo Tacconi, Marianna Di Filippi, Nico Attempati, Leonardo Palombi, Leonardo Ercolini and Leonardo Bolognese

J. Clin. Med. 2021, 10(10), 2213; https://doi.org/10.3390/jcm10102213 - 20 May 2021

Cited by 17 | Viewed by 2392

Abstract

Peripheral blood mononuclear cells (PBMNCs) are reported to prevent major amputation and healing in no-option critical limb ischemia (NO-CLI). The aim of this study is to evaluate PBMNC treatment in comparison to standard treatment in NO-CLI patients with diabetic foot ulcers (DFUs). The [...] Read more.

Peripheral blood mononuclear cells (PBMNCs) are reported to prevent major amputation and healing in no-option critical limb ischemia (NO-CLI). The aim of this study is to evaluate PBMNC treatment in comparison to standard treatment in NO-CLI patients with diabetic foot ulcers (DFUs). The study included 76 NO-CLI patients admitted to our centers because of CLI with DFUs. All patients were treated with the same standard care (control group), but 38 patients were also treated with autologous PBMNC implants. Major amputations, overall mortality, and number of healed patients were evaluated as the primary endpoint. Only 4 out 38 amputations (10.5%) were observed in the PBMNC group, while 15 out of 38 amputations (39.5%) were recorded in the control group (p = 0.0037). The Kaplan–Meier curves and the log-rank test results showed a significantly lower amputation rate in the PBMNCs group vs. the control group (p = 0.000). At two years follow-up, nearly 80% of the PBMNCs group was still alive vs. only 20% of the control group (p = 0.000). In the PBMNC group, 33 patients healed (86.6%) while only one patient healed in the control group (p = 0.000). PBMNCs showed a positive clinical outcome at two years follow-up in patients with DFUs and NO-CLI, significantly reducing the amputation rate and improving survival and wound healing. According to our study results, intramuscular and peri-lesional injection of autologous PBMNCs could prevent amputations in NO-CLI diabetic patients. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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Review

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33 pages, 6892 KiB

Open AccessReview

Cardiovascular/Stroke Risk Stratification in Diabetic Foot Infection Patients Using Deep Learning-Based Artificial Intelligence: An Investigative Study

by Narendra N. Khanna, Mahesh A. Maindarkar, Vijay Viswanathan, Anudeep Puvvula, Sudip Paul, Mrinalini Bhagawati, Puneet Ahluwalia, Zoltan Ruzsa, Aditya Sharma, Raghu Kolluri, Padukone R. Krishnan, Inder M. Singh, John R. Laird, Mostafa Fatemi, Azra Alizad, Surinder K. Dhanjil, Luca Saba, Antonella Balestrieri, Gavino Faa, Kosmas I. Paraskevas, Durga Prasanna Misra, Vikas Agarwal, Aman Sharma, Jagjit S. Teji, Mustafa Al-Maini, Andrew Nicolaides, Vijay Rathore, Subbaram Naidu, Kiera Liblik, Amer M. Johri, Monika Turk, David W. Sobel, Martin Miner, Klaudija Viskovic, George Tsoulfas, Athanasios D. Protogerou, Sophie Mavrogeni, George D. Kitas, Mostafa M. Fouda, Mannudeep K. Kalra and Jasjit S. Suri Show full author list Hide full author list

J. Clin. Med. 2022, 11(22), 6844; https://doi.org/10.3390/jcm11226844 - 19 Nov 2022

Cited by 10 | Viewed by 3828

Abstract

A diabetic foot infection (DFI) is among the most serious, incurable, and costly to treat conditions. The presence of a DFI renders machine learning (ML) systems extremely nonlinear, posing difficulties in CVD/stroke risk stratification. In addition, there is a limited number of well-explained [...] Read more.

A diabetic foot infection (DFI) is among the most serious, incurable, and costly to treat conditions. The presence of a DFI renders machine learning (ML) systems extremely nonlinear, posing difficulties in CVD/stroke risk stratification. In addition, there is a limited number of well-explained ML paradigms due to comorbidity, sample size limits, and weak scientific and clinical validation methodologies. Deep neural networks (DNN) are potent machines for learning that generalize nonlinear situations. The objective of this article is to propose a novel investigation of deep learning (DL) solutions for predicting CVD/stroke risk in DFI patients. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) search strategy was used for the selection of 207 studies. We hypothesize that a DFI is responsible for increased morbidity and mortality due to the worsening of atherosclerotic disease and affecting coronary artery disease (CAD). Since surrogate biomarkers for CAD, such as carotid artery disease, can be used for monitoring CVD, we can thus use a DL-based model, namely, Long Short-Term Memory (LSTM) and Recurrent Neural Networks (RNN) for CVD/stroke risk prediction in DFI patients, which combines covariates such as office and laboratory-based biomarkers, carotid ultrasound image phenotype (CUSIP) lesions, along with the DFI severity. We confirmed the viability of CVD/stroke risk stratification in the DFI patients. Strong designs were found in the research of the DL architectures for CVD/stroke risk stratification. Finally, we analyzed the AI bias and proposed strategies for the early diagnosis of CVD/stroke in DFI patients. Since DFI patients have an aggressive atherosclerotic disease, leading to prominent CVD/stroke risk, we, therefore, conclude that the DL paradigm is very effective for predicting the risk of CVD/stroke in DFI patients. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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11 pages, 1879 KiB

Open AccessReview

Ultrasound-Assisted Wound (UAW) Debridement in the Treatment of Diabetic Foot Ulcer: A Systematic Review and Meta-Analysis

by Sebastián Flores-Escobar, Francisco Javier Álvaro-Afonso, Yolanda García-Álvarez, Mateo López-Moral, José Luis Lázaro-Martínez and Esther García-Morales

J. Clin. Med. 2022, 11(7), 1911; https://doi.org/10.3390/jcm11071911 - 30 Mar 2022

Cited by 9 | Viewed by 3070

Abstract

A systematic review and meta-analysis were carried out to investigate the effect of ultrasound-assisted wound (UAW) debridement in patients with diabetic foot ulcers (DFUs). All selected studies were evaluated using the Cochrane risk of bias tool to assess the risk of bias for [...] Read more.

A systematic review and meta-analysis were carried out to investigate the effect of ultrasound-assisted wound (UAW) debridement in patients with diabetic foot ulcers (DFUs). All selected studies were evaluated using the Cochrane risk of bias tool to assess the risk of bias for randomized controlled trials. PubMed and Web of Science were searched in October 2021 to find randomized clinical trials (RCT) assessing the effect of UAW debridement on DFUs. RevMan v5.4. was used to analyze the data with the Mantel–Haenszel method for dichotomous outcomes. A total of 8 RCT met our inclusion criteria, with 263 participants. Concerning the healing rate comparing UAW versus the control group, a meta-analysis estimated the pooled OR at 2.22 (95% CI 0.96–5.11, p = 0.06), favoring UAW debridement, with low heterogeneity (x² = 7.47, df = 5, p = 0.19, I² = 33%). Time to healing was similar in both groups: UAW group (14.25 ± 10.10 weeks) versus the control group (13.38 ± 1.99 weeks, p = 0.87). Wound area reduction was greater in the UAW debridement group (74.58% ± 19.21%) than in the control group (56.86% ± 25.09%), although no significant differences were observed between them (p = 0.24). UAW debridement showed higher healing rates, a greater percentage of wound area reduction, and similar healing times when compared with placebo (sham device) and standard of care in patients with DFUs, although no statistically significant differences were observed between groups. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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27 pages, 1299 KiB

Open AccessReview

The Immune-Centric Revolution in the Diabetic Foot: Monocytes and Lymphocytes Role in Wound Healing and Tissue Regeneration—A Narrative Review

by Laura Rehak, Laura Giurato, Marco Meloni, Andrea Panunzi, Giada Maria Manti and Luigi Uccioli

J. Clin. Med. 2022, 11(3), 889; https://doi.org/10.3390/jcm11030889 - 08 Feb 2022

Cited by 29 | Viewed by 7609

Abstract

Monocytes and lymphocytes play a key role in physiologic wound healing and might be involved in the impaired mechanisms observed in diabetes. Skin wound macrophages are represented by tissue resident macrophages and infiltrating peripheral blood recruited monocytes which play a leading role during [...] Read more.

Monocytes and lymphocytes play a key role in physiologic wound healing and might be involved in the impaired mechanisms observed in diabetes. Skin wound macrophages are represented by tissue resident macrophages and infiltrating peripheral blood recruited monocytes which play a leading role during the inflammatory phase of wound repair. The impaired transition of diabetic wound macrophages from pro-inflammatory M1 phenotypes to anti-inflammatory pro-regenerative M2 phenotypes might represent a key issue for impaired diabetic wound healing. This review will focus on the role of immune system cells in normal skin and diabetic wound repair. Furthermore, it will give an insight into therapy able to immuno-modulate wound healing processes toward to a regenerative anti-inflammatory fashion. Different approaches, such as cell therapy, exosome, and dermal substitute able to promote the M1 to M2 switch and able to positively influence healing processes in chronic wounds will be discussed. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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Open AccessReview

Is There an Association between Sleep Disorders and Diabetic Foot? A Scoping Review

by Raúl Fernández-Torres, María Ruiz-Muñoz, Ana J. Pérez-Belloso, Jerónimo García-Romero and Manuel Gónzalez-Sánchez

J. Clin. Med. 2021, 10(11), 2530; https://doi.org/10.3390/jcm10112530 - 07 Jun 2021

Cited by 5 | Viewed by 2580

Abstract

Diabetic foot is associated with a low quality of life since physical disabilities, mood disturbances and psychological disorders are frequent. One of the most important biological processes to ensure quality of life is sleep. Sleep disorders can impair glycemic control in patients with [...] Read more.

Diabetic foot is associated with a low quality of life since physical disabilities, mood disturbances and psychological disorders are frequent. One of the most important biological processes to ensure quality of life is sleep. Sleep disorders can impair glycemic control in patients with diabetes mellitus or even cause long-term type 2 diabetes mellitus. The aim of this study is to carry out a scoping review about the association between sleep cycle disorders and diabetic foot. PubMed, Scopus, CINAHL, PEDro, Cochrane Library, SCIELO and EMBASE databases were chosen for the search and the following terms were used: “diabetic foot”,“sleep*”,“rest-activity”,“mood” and“behavior”. All the studies should include outcome variables about sleep and diabetic foot. Finally, 12 articles were selected, all of whichwere observational. The most frequent variables were those regarding diabetic foot ulcer aspects and diabetic neuropathy on one side, and obstructive sleep apnea, sleep duration and sleep quality on the other side. The results suggest that there is a possible association between obstructive sleep apnea and the presence or history of diabetic foot ulcers. No direct associations between sleep quality or sleep duration and diabetic foot or diabetic foot ulcer variables have been found. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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12 pages, 620 KiB

Open AccessSystematic Review

Effectiveness of Percutaneous Flexor Tenotomies for the Prevention and Management of Toe-Related Diabetic Foot Ulcers: A Systematic Review

by María M. Calvo-Wright, Mateo López-Moral, Yolanda García-Álvarez, Marta García-Madrid, Francisco J. Álvaro-Afonso and José Luis Lázaro-Martínez

J. Clin. Med. 2023, 12(8), 2835; https://doi.org/10.3390/jcm12082835 - 12 Apr 2023

Cited by 1 | Viewed by 3181

Abstract

There is a high prevalence of digital deformities in diabetic patients, particularly claw toe, which can result in ulceration, often located at the tip of the toe. These lesions are challenging to off-load with conventional devices and frequently lead to infection and high [...] Read more.

There is a high prevalence of digital deformities in diabetic patients, particularly claw toe, which can result in ulceration, often located at the tip of the toe. These lesions are challenging to off-load with conventional devices and frequently lead to infection and high amputation rates. Recent guidelines recommend considering flexor tenotomies to manage these ulcerations and prevent complications. This review, which analyzed 11 studies, aimed to assess the effect of flexor tenotomies on the healing and prevention of diabetic foot ulcers (DFUs) at the toe tip. Satisfactory results were found, with a healing rate of 92% to 100% and a mean healing time of 2–4 weeks. Few mild complications were observed, and the recurrence rate was very low. Transfer lesions were the most prevalent, but simultaneous tenotomy of all toes can eliminate this risk. Flexor tenotomies are a simple, effective, and safe procedure for the treatment and management of DFUs located at the apex of the toes and should be considered part of the standard of care for diabetic feet. Full article

(This article belongs to the Special Issue Diabetic Foot Complications: Current Challenges and Future Prospects—Part II)

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