Search Results (12)

Monitoring plantar foot temperatures is essential for assessing foot health, particularly in individuals with diabetes at increased risk of complications. Traditional thermographic imaging measures foot temperatures in unshod individuals lying down, which may not reflect thermal characteristics of feet in shod, active, real-world conditions. These controlled settings limit understanding of dynamic foot temperatures during daily activities. Recent advancements in wearable technology, such as insole-based sensors, overcome these limitations by enabling continuous temperature monitoring. This study leverages a data-driven clustering approach, independent of pre-selected foot regions or models like the angiosome concept, to explore normative thermal patterns in shod feet with insole-based sensors. Data were collected from 27 healthy participants using insoles embedded with 21 temperature sensors. The data were analysed using clustering algorithms, including k-means, fuzzy c-means, OPTICS, and hierarchical clustering. The clustering algorithms showed a high degree of similarity, with variations primarily influenced by clustering granularity. Six primary thermal patterns were identified, with the “butterfly pattern” (elevated medial arch temperatures) predominant, representing 51.5% of the dataset, aligning with findings in thermographic studies. Other patterns, like the “medial arch + metatarsal area” pattern, were also observed, highlighting diverse yet consistent thermal distributions. This study shows that while normative thermal patterns observed in thermographic imaging are reflected in insole data, the temperature distribution within the shoe may better represent foot behaviour during everyday activities, particularly when enclosed in a shoe. Unlike thermal imaging, the proposed in-shoe system offers the potential to capture dynamic thermal variations during ambulatory activities, enabling richer insights into foot health in real-world conditions. Full article

Background: The primary approach for treating ischemic wounds is restoring oxygen supply to the ischemic region. While direct angiosomal revascularization is often associated with better post-operative wound healing and limb salvage, its superiority over non-angiosomal revascularization remains controversial. This study aimed to compare intraoperative tissue oxygen saturation changes in ischemic zones following either direct or indirect revascularization in below-the-knee arteries. Methods: This prospective observational study included patients undergoing direct and indirect below-the-knee endovascular revascularizations. Assignment to the groups was not randomized. Near-infrared spectroscopy was used to monitor rSO2 changes near the ischemic wounds intraoperatively. The changes were compared between the groups. Results: 15 patients (50%) underwent direct angiosomal revascularization, while an equal number of patients underwent indirect revascularization. Overall, a statistically significant increase in regional oxygen saturation was observed after revascularization (p = 0.001). No statistically significant difference was found between the direct and indirect revascularization groups (p = 0.619). Conclusions: This study revealed a minor difference in the oxygen saturation increase between the angiosomal and non-angiosomal revascularization groups. Such a finding indicates that the clinical significance of angiosomal revascularization is negligible and might be concealed by confounding factors, such as the vessel diameter and outflow impact on the restenosis rate. Full article

Background: Revascularization based on the angiosome concept (AC) is a controversial subject because there is currently no clear evidence of its efficacy, due to the heterogeneity of patients (multiple and diverse risk factors and comorbidities, multiple variations in the affected angiosomes). Choke vessels change the paradigm of the AC, and the presence or absence of the plantar arch directly affects the course of targeted revascularization. The aim of this study was to evaluate the effect of revascularization based on the AC in diabetic patients with chronic limb-threatening ischemia (CLTI). Methods: This retrospective analysis included 51 patients (40 men, 11 women), with a mean age of 69 years (66–72) and a total of 51 limbs, who presented with Rutherford 5–6 CLTI, before and after having undergone a drug-coated balloon angioplasty (8 patients) or plain balloon angioplasty (43). Between November 2018 and November 2019, all patients underwent below-the-knee balloon angioplasties and were followed up for an average of 12 months. The alteration of microcirculation was compared between directly and indirectly revascularized angiosomes. The study assessed clinical findings and patient outcomes, with follow-up investigations, comparing wound healing rates between the different revascularization methods. Patient records and periprocedural leg digital subtraction angiographies (DSA) were analyzed. Differences in outcomes after direct revascularization and indirect percutaneous transluminal angioplasty (PTa) were examined using Cox proportional hazards analysis, with the following endpoints: ulcer healing, limb salvage, and also amputation-free survival. Results: Direct blood flow to the angiosome supplying the ulcer area was achieved in 38 legs, in contrast to 13 legs with indirect revascularization. Among the cases, there were 39 lesions in the anterior tibial artery (ATA), 42 lesions in the posterior tibial artery (PTA), and 8 lesions in the peroneal artery (PA). According to a Cox proportional hazards analysis, having fewer than three (<3) affected angiosomes (HR 0.49, 95% CI 0.19–1.25, p = 0.136) was associated with improved wound healing. Conversely, wound healing outcomes were least favorable after indirect angioplasty (p = 0.206). When adjusting the Cox proportional hazard analysis for the number of affected angiosomes, it was found that direct drug-coated angioplasty resulted in the most favorable wound healing (p = 0.091). At the 1-year follow-up, the major amputation rate was 17.7%, and, according to a Cox proportional hazards analysis, atrial fibrillation (HR 0.85, 95% CI 0.42–1.69, p = 0.637), hemodialysis (HR 1.26, 95% CI 0.39–4.04, p = 0.699), and number of affected angiosomes > 3 (HR 0.94, 95% CI 0.63–1.39, p = 0.748) were significantly associated with poor leg salvage. Additionally, direct endovascular revascularization was associated with a lower rate of major amputation compared to indirect angioplasty (HR 1.09, 95% CI 0.34–3.50, p = 0.884). Conclusions: Observing the angiosomes concept in decision-making appears to result in improved rates of arterial ulcer healing and leg salvage, particularly in targeted drug-coated balloon angioplasty for diabetic critical limb ischemia, where multiple angiosomes are typically affected. Full article

Diabetic foot ulcers represent the most frequently recognized and highest risk factor among patients affected by diabetes mellitus. The associated recurrent rate is high, and amputation of the foot or lower limb is often required due to infection. Analysis of infrared thermograms covering the entire plantar aspect of both feet is considered an emerging area of research focused on identifying at an early stage the underlying conditions that sustain skin and tissue damage prior to the onset of superficial wounds. The identification of foot disorders at an early stage using thermography requires establishing a subset of relevant features to reduce decision variability and data misinterpretation and provide a better overall cost–performance for classification. The lack of standardization among thermograms as well as the unbalanced datasets towards diabetic cases hinder the establishment of this suitable subset of features. To date, most studies published are mainly based on the exploitation of the publicly available INAOE dataset, which is composed of thermogram images of healthy and diabetic subjects. However, a recently released dataset, STANDUP, provided data for extending the current state of the art. In this work, an extended and more generalized dataset was employed. A comparison was performed between the more relevant and robust features, previously extracted from the INAOE dataset, with the features extracted from the extended dataset. These features were obtained through state-of-the-art methodologies, including two classical approaches, lasso and random forest, and two variational deep learning-based methods. The extracted features were used as an input to a support vector machine classifier to distinguish between diabetic and healthy subjects. The performance metrics employed confirmed the effectiveness of both the methodology and the state-of-the-art features subsequently extracted. Most importantly, their performance was also demonstrated when considering the generalization achieved through the integration of input datasets. Notably, features associated with the MCA and LPA angiosomes seemed the most relevant. Full article

The current study aimed to evaluate the effectiveness of peripheral blood mononuclear cell (PB-MNC) therapy as adjuvant treatment for patients with diabetic foot ulcers (DFUs) and no-option critical limb ischaemia (NO-CLI). The study is a prospective, noncontrolled, observational study including patients with neuro-ischaemic DFUs and NO-CLI who had unsuccessful revascularization below the ankle (BTA) and persistence of foot ischaemia defined by TcPO2 values less than 30 mmHg. All patients received three cycles of PB-MNC therapy administered through a “below-the-ankle approach” in the affected foot along the wound-related artery according to the angiosome theory. The primary outcome measures were healing, major amputation, and survival after 1 year of follow-up. The secondary outcome measures were the evaluation of tissue perfusion by TcPO2 and foot pain defined by the numerical rating scale (NRS). Fifty-five patients were included. They were aged >70 years old and the majority were male and affected by type 2 diabetes with a long diabetes duration (>20 years); the majority of DFUs were infected and nearly 90% were assessed as gangrene. Overall, 69.1% of patients healed and survived, 3.6% healed and deceased, 10.9% did not heal and deceased, and 16.4% had a major amputation. At baseline and after PB-MNC therapy, the TcPO2 values were 17 ± 11 and 41 ± 12 mmHg, respectively (p < 0.0001), while the pain values (NRS) were 6.8 ± 1.7 vs. 2.8 ± 1.7, respectively (p < 0.0001). Any adverse event was recorded during the PB-MNC therapy. Adjuvant PB-MNC therapy seems to promote good outcomes in patients with NO-CLI and neuro-ischaemic DFUs. Full article

Augmenting the vascular supply to generate new tissues, a crucial aspect in regenerative medicine, has been challenging. Recently, our group showed that calcium phosphate can induce the formation of a functional neo-angiosome without the need for microsurgical arterial anastomosis. This was a preclinical proof of concept for biomaterial-induced luminal sprouting of large-diameter vessels. In this study, we investigated if sprouting was a general response to surgical injury or placement of an inorganic construct around the vessel. Cylindrical biocement scaffolds of differing chemistries were placed around the femoral vein. A contrast agent was used to visualize vessel ingrowth into the scaffolds. Cell populations in the scaffold were mapped using immunohistochemistry. Calcium phosphate scaffolds induced 2.7–3 times greater volume of blood vessels than calcium sulphate or magnesium phosphate scaffolds. Macrophage and vSMC populations were identified that changed spatially and temporally within the scaffold during implantation. NLRP3 inflammasome activation peaked at weeks 2 and 4 and then declined; however, IL-1β expression was sustained over the course of the experiment. IL-8, a promoter of angiogenesis, was also detected, and together, these responses suggest a role of sterile inflammation. Unexpectedly, the effect was distinct from an injury response as a result of surgical placement and also was not simply a foreign body reaction as a result of placing a rigid bioceramic next to a vein, since, while the materials tested had similar microstructures, only the calcium phosphates tested elicited an angiogenic response. This finding then reveals a potential path towards a new strategy for creating better pro-regenerative biomaterials. Full article

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

(1) Background: Although the ankle–brachial index (ABI) and skin perfusion pressure (SPP) are commonly used to evaluate the peripheral circulation in critical limb ischemia (CLI), they often cannot be performed on sore areas. We investigated the utility of superb microvascular imaging (SMI) for assessing foot perfusion in CLI patients. (2) Methods: We measured the SMI-based vascular index (SMI-VI) at six sites in the foot before and after endovascular treatment (EVT) in 50 patients with CLI who underwent EVT of the superficial femoral artery and compared the results with SPP values and the ABI. (3) Results: SMI visualized foot perfusion in all subjects in accordance with the angiosome, including the toe areas, while the ABI was unmeasurable in three patients on hemodialysis and SPP failed in four patients. SMI-VI values were significantly lower in the CLI group than in controls, and the plantar SMI-VI had the highest diagnostic performance for CLI (sensitivity 88.6%, specificity 95.6%). After EVT, the increase in the SMI-VI was positively correlated with the increase in SPP but not that in the ABI, implying that the SMI-VI reflects foot microcirculation. (4) Conclusions: SMI enables the visualization and quantification of foot microcirculation based on the angiosome. SMI has high utility as a tool for assessing foot perfusion in CLI. Full article

One of the most serious problems in people with diabetes is diabetic foot syndrome. Due to the peripheral location of atherosclerotic lesions in the arterial system of the lower extremities, endovascular treatment plays a dominant role. However, carrying out these procedures is not always possible and does not always bring the expected results. Gene therapy, which stimulates angiogenesis, improves not only the inflow from the proximal limb but also the blood redistribution in individual angiosomes. Due to the encouraging results of sequential treatment consisting of intramuscular injections of VEGF/HGF bicistronic plasmids followed by a month of ANG1 plasmids, we decided to use the described method for the treatment of critical ischemia of the lower limbs in the course of diabetes and, more specifically, in diabetic foot syndrome. Twenty-four patients meeting the inclusion criteria were enrolled in the study. They were randomly divided into two equal groups. The first group of patients was subjected to gene therapy, where the patients received intramuscular injections of pIRES/VEGF165/HGF plasmids and 1 month of ANG-1 plasmids. The remaining patients constituted the control group. Gene therapy was well tolerated by most patients. The wounds healed significantly better in Group 1. The minimal value of ABI increased significantly in Group 1 from 0.44 ± 0.14 (± standard deviation) to 0.47 ± 0.12 (with p = 0.028) at the end of the study. There were no significant differences in the control group. In the gene treatment group, PtcO2 increased significantly (from 28.71 ± 10.89 mmHg to 33.9 ± 6.33 mmHg with p = 0.001), while in Group 2, no statistically significant changes were found. The observed resting pain decreased significantly in both groups (Group 1 decreased from 6.80 ± 1.48 to 2.10 ± 1.10; p < 0.001; the control group decreased from 7.44 ± 1.42 to 3.78 ± 1.64 with p < 0.001). In our study, we evaluated the effectiveness of gene therapy with the growth factors described above in patients with CLI in the course of complicated DM. The therapy was shown to be effective with minimal side effects. No serious complications were observed. Full article

Biocompatible hyaluronic acid (HA, hyaluronan) gel implants have altered the therapeutic landscape of surgery and medicine, fostering an array of innovative products that include viscosurgical aids, synovial supplements, and drug-eluting nanomaterials. However, it is perhaps the explosive growth in the cosmetic applications of injectable dermal fillers that has captured the brightest spotlight, emerging as the dominant modality in plastic surgery and aesthetic medicine. The popularity surge with which injectable HA fillers have risen to in vogue status has also brought a concomitant increase in the incidence of once-rare iatrogenic vaso-occlusive injuries ranging from disfiguring facial skin necrosis to disabling neuro-ophthalmological sequelae. As our understanding of the pathophysiology of these injuries has evolved, supplemented by more than a century of astute observations, the formulation of novel therapeutic and preventative strategies has permitted the amelioration of this burdensome complication. In this special issue article, we review the relevant mechanisms underlying HA filler-induced vascular occlusion (FIVO), with particular emphasis on the rheo-mechanical aspects of vascular blockade; the thromboembolic potential of HA mixtures; and the tissue-specific ischemic susceptibility of microvascular networks, which leads to underperfusion, hypoxia, and ultimate injury. In addition, recent therapeutic advances and novel considerations on the prevention and management of muco-cutaneous and neuro-ophthalmological complications are examined. Full article

Background: Assessment of tissue oxygenation is an important aspect of detection and monitoring of patients with peripheral artery disease (PAD). Hyperspectral imaging (HSI) is a non-contact technology for assessing microcirculatory function by quantifying tissue oxygen saturation (StO₂). This study investigated whether HSI can be used to monitor skin oxygenation in patients with PAD after appropriate treatment of the lower extremities. Methods: For this purpose, 37 patients with PAD were studied by means of ankle–brachial index (ABI) and HSI before and after surgical or endovascular therapy. Thereby, the oxygenation parameter StO₂ and near infrared (NIR) perfusion index were quantified in seven angiosomes on the diseased lower leg and foot. In addition, the effects of skin temperature and physical activity on StO₂ and the NIR perfusion index and the respective inter-operator variability of these parameters were investigated in 25 healthy volunteers. Results: In all patients, the ABI significantly increased after surgical and endovascular therapy. In parallel, HSI revealed significant changes in both StO₂ and NIR perfusion index in almost all studied angiosomes depending on the performed treatment. The increase in tissue oxygenation saturation was especially pronounced after surgical treatment. Neither heat nor cold, nor physical activity, nor repeated assessments of HSI parameters by independent investigators significantly affected the results on StO₂ and the NIR perfusion index. Conclusions: Tissue oxygen saturation data obtained with HSI are robust to external confounders, such as temperature and physical activity, and do not show inter-operator variability; therefore, can be used as an additional technique to established methods, such as the ABI, to monitor peripheral perfusion in patients with PAD. Full article

Tibial plateau fractures (TPFs) are challenging, requiring complex open reduction and internal fixation (ORIF) and are often associated with complications including surgical site infections (SSIs). In 2007, we introduced a novel management protocol to treat TPFs which consisted of an angiosome- or perforator-sparing (APS) anterolateral approach followed by unrestricted weight bearing and range of motion. The primary aim of this retrospective study was to investigate complication rates and patient outcomes associated with our new management protocol. In total, 79 TPFs treated between 2004 and 2007 through a classic anterolateral surgical approach formed the “Classic Group”; while 66 TPFS treated between 2007 and 2013 formed the “APS Group”. Fracture reduction, maintenance of reduction and patient-reported outcomes were assessed. There was a clinically important improvement in the infection incidence with the APS (1.5%) versus the Classic technique (7.6%) (1/66 versus 2/79 for superficial infections; 0/66 versus 4/79 for deep infections). Despite a more aggressive rehabilitation, there was no difference in the fracture reduction over time or the functional outcomes between both groups (p > 0.05). The APS anterolateral approach improved the rate of SSIs after TPFs without compromising fracture reduction and stabilisation. We continue to use this new management approach and early unrestricted weight bearing when treating amenable TPFs. Full article