Neuroischemic Diabetic Foot Research Articles

The short- and long-term results of therapy of surgical diabetic foot patients

Introduction. The arterial limb threating is the leading cause of non-traumatic amputations in diabetic foot patients. The breakthrough in the treatment of this group of patients was the widespread introduction of transluminal balloon angioplasty (TLBA) of the arteries of the lower extremities.Aim. To evaluate the results of the surgical treatment of the patients with diabetic neuro ischemic foot syndrome according the data of Government Center of Limb Salvation in 2022–2023 years.Materials and methods. The study presents a retrospective analysis of medical documentations and the results of a survey one year after discharge from the hospital of 180 patients.Results. The arterial limb threating is observed in equal frequency in both men with diabetes and women at a relatively young age (66.0 ± 12.8 years). The glycemic control in most patients is above the target values. Various groups of sugar-lowering drugs are widely used. More than a third of patients with CKD suffer from CKD with GFR less than 60 ml/min, however inSGLT-2 are used in slightly more than 15% of cases. The damages of the lower extremities arteries below the knee are observed in the most of cases. Every third patient has the occlusion/hemodynamically significant stenosis of the femoral and tibia arteries. The method of choosing revascularization is TLBA the lower extremities arteries without stenting, hybrid operations are performed in up to 10% of cases in the hospital. During the first year of follow up the 21.2% of the patients have recurrences of the ischemic tissue lesions of the feet including revascularization. The recurrences of the ischemic tissue lesions of the feet after surgical approach are revealed in 9% cases only. There are TLBA in all other cases. The mortality rate is 9.6 cases per 100 patients per year.Conclusion. The patients after revascularization for the neuro-ischemic diabetic foot tissue loss and limb salvage remain at high risk of both mortality and recurrence of arterial limb threating in the early and delayed follow up.

Recurrence rates after healing in patients with neuroischemic diabetic foot ulcers healed with and without sucrose octasulfate-impregnated dressings: A 1-year comparative prospective study.

To compare recurrence rates after a 1-year follow-up period of healed neuroischemic diabetic foot ulcers after treatment with or without sucrose octasulfate impregnated dressing. A 1-year prospective study with two arms was conducted between April 2021 and April 2023 on 92 patients with healed neuroischemic diabetic foot ulcers. Patients were divided into two groups; the treatment group, that includes patients healed with a sucrose octasulfate-impregnated dressing, and the control group, which includes patients treated with other local treatments different from sucrose octasulfate-impregnated dressings. After healing, patients were prospectively followed up during 1-year and assessed monthly in the specialised outpatient clinics. The main outcome of the study was ulcer recurrence after wound healing within 1 year follow-up. Secondary outcomes were minor or major amputation and all causes of death. Fifty patients in the treatment group and 42 patients in the control group were included. Fourteen (28%) patients suffered from a reulceration event in the treatment group compared to 28 (66.7%) in the control group, p < 0.001. Time to recurrence in the treatment group was 10 (16.26-2.75) and 11.50 (30.75-5.25) weeks in the control group, p = 0.464. There were no observed differences in the minor amputation rates between the two groups: 15.2% (n = 7) in the treatment group and 7.1% (n = 3) in the control group (p = 0.362). Major amputations and death outcomes were exclusively observed in the treatment group. Specifically, four major amputations (8.7%) in the treatment group were complications arising from recurring events complicated by infection during the SARS-CoV-2 period. Seven patients died due to complications not related with local therapy. The relative risk of recurrence was 20.18 times higher in the control group compared with those treated with octasulfate dressing (p < 0.001). Treatment with sucrose octasulfate-impregnated dressings can decrease recurrence rates of neuroischaemic diabetic foot ulcers more effectively than neutral dressings. Besides, it may enhance the foot's clinical properties in patients with poor microcirculation, which could aid in preventing future recurrences.

Comparative Outcomes of Targeted Versus Nontargeted Angiosome Revascularization for Diabetic Foot Wounds Impact of Target Arterial Path on Wound Healing

Diabetes is strongly correlated with the development of critical limb ischemia (CLI), with a predilection for below-the-knee and below-the-ankle patterns of arterial disease. The angiosome concept, described as a potential framework for targeted revascularization in CLI, has generated divergent opinions over the last decades. This study aims to evaluate the implication of angiosome targeted revascularization in wound healing in diabetic patients. This is a single-center retrospective study including diabetic patients with ischemic ulcers admitted for invasive vascular study and revascularization between January and December 2019. The primary outcome was to evaluate the impact of angiosome-targeted revascularization in wound healing. Limb-based patency and amputation-free survival according to GLASS stage and revascularization procedures were considered secondary outcomes. Data from 117 limbs of 114 diabetic patients with neuroischemic diabetic foot were evaluated. There was no significant difference between targeted and non-targeted angiosome-revascularization in wound healing at 12 months. However, angiosome targeted revascularization was associated with shorter healing times. The severity of the infection was the only variable with an impact on healing time. Endovascular surgery did not show inferior patency to open surgery, even in patients with more complex arterial disease (GLASS III). Although angiosome-guided revascularization did not demonstrate significantly higher healing rates at 12 months, there appears to be a trend towards faster healing.

A Single Center, Randomized Controlled Trial on the Efficacy of Topical Application of ReGenerating Tissue Agents (RGTA) Technology in Diabetic Foot Ulcers.

Diabetic foot ulcers (DFUs) are a serious complication of diabetes mellitus. Clinical data from the use of ReGenerating Tissue Agents (RGTA) technology in patients with DFUs are scarce. The objective of this randomized controlled study was to evaluate the efficacy of RGTA technology in the management of DFUs. Patients with chronic, neuroischemic diabetic foot ulcers were randomized 1:1 to the control group, that received the standard of care, and to the intervention group, that additionally received RGTA twice per week. The duration of the intervention was 12 weeks. Skin biopsies for histological and immunohistochemical analyses from a sample of participants were also performed. About 31 patients completed the study. Five (31.2%) patients in the intervention group achieved complete healing at the end of the intervention period versus 0 patients in the control group (P = .043), [RR: 0.688 (95% CI: 0.494-0.957)]. The intervention group had more ulcers with at least 80% healing of their surface [10 (66.7%) versus 2 (13.3%), P = .008, RR: 0.385 (95% CI: 0.183-0.808)], higher absolute surface reduction [1.5 (0.7, 5.2) versus 0.6 (0.3, 1.0), P = .026] and higher percentages of surface reduction [94 (67, 100) versus 40 (26, 75), P = .001] at the end of the intervention period. More patients in the intervention group achieved at least 50% healing at the fourth week of the study [9 (64.3%) versus 2 (14.3%) P = .018, RR: 0.417 (95% CI: 0.200-0.869)]. Immunohistochemical analyses were performed in a sample of participants that revealed higher expression of CD163, COL3 and VEGFR in the intervention group. The adverse effects were similar between the 2 groups. The data from the present study suggest that the adjunction of RGTA technology in the management of diabetic foot ulcers is a safe practice that promotes wound healing.

Gene therapy for diabetic foot ulcers: Interim analysis of a randomised, placebo-controlled phase 3 study of VM202 (ENGENSIS), a plasmid DNA expressing two isoforms of human hepatocyte growth factor.

To evaluate the status of a 7-month phase 3 study conducted to test the effect of intramuscular injections of VM202 (ENGENSIS), a plasmid DNA encoding human hepatocyte growth factor, into the calf muscles of chronic nonhealing diabetic foot ulcers with concomitant peripheral artery disease. The phase 3 study, originally aimed to recruit 300 subjects, was discontinued because of slow patient recruitment. An unprespecified interim analysis was performed for the 44 subjects enrolled to assess the status and determine the future direction. Statistical analyses were carried out for the Intent-to-Treat (ITT) population and separately for subjects with neuroischemic ulcers, using a t-test and Fisher's exact test. A logistic regression analysis was also conducted. VM202 was safe and potentially should have benefits. In the ITT population (N = 44), there was a positive trend toward closure in the VM202 group from 3 to 6 months but with no statistical significance. Levels of ulcer volume or area were found to be highly skewed between the placebo and VM202 groups. Forty subjects, excluding four outliers in both arms, showed significant wound-closing effects at month 6 (P = .0457). In 23 patients with neuroischemic ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4, and 5 (P = .0391, .0391, and .0361). When two outliers were excluded, a significant difference was evident in months 3, 4, 5, and 6 (P = .03 for all points). A potentially clinically meaningful 0.15 increase in Ankle-Brachial Index was observed in the VM202 group at day 210 in the ITT population (P = .0776). Intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in the treatment of chronic neuroischemic diabetic foot ulcers (DFUs). Given the safety profile and potential healing effects, continuing a larger DFU study is warranted with modifications of the current protocol and expansion of enrolling sites.

New antioxidant therapy for hard-to-heal neuroischaemic diabetic foot ulcers with deep exposure.

To evaluate the clinical efficacy of a new antioxidant therapy for the treatment of complex neuroischaemic diabetic foot ulcers (DFUs). A prospective case series study has been conducted in patients with complex neuroischaemic DFUs after transmetatarsal amputation. DFUs were locally treated with an antioxidant dressing twice a week for the first two weeks, and then once a week until the end of the study or complete wound closure. Patients were followed-up for eight weeks and assessed weekly to analyse wound outcome. Primary outcomes were the wound closure ratio and percentage of granulation tissue; secondary outcomes were parameters related to wound management, namely, presence of non-viable tissue in the wound bed, levels of maceration and exudates, presence of erythema and pain. A total of 20 patients were included with a mean baseline wound area of 20.4cm2. At 8 weeks, the mean reduction in wound area was 88.1% (p<0.0001) and complete closure was observed in 33% of cases. In addition, there was a mean increase of 94.7% in granulation tissue in the wound bed (p<0.0001). Furthermore, the therapy was associated with a significant percentage reduction in wounds with non-viable tissue, good exudate management, and the maintenance of low levels of maceration, erythema and pain. The new antioxidant therapy was associated with good clinical outcomes in large hard-to-heal neuroischaemic DFUs, with significant wound area reduction and granulation tissue formation. The therapy was also found to be safe and perform well from a practical perspective.

Overcoming Barriers to Wound Healing in a Neuropathic and Neuro-Ischaemic Diabetic Foot Cohort Using a Novel Bilayer Biodegradable Synthetic Matrix.

Diabetes-related foot ulceration presents an increasing risk of lower limb amputation globally, driving the search for new treatment technologies. Our single-centre prospective observational study reports on the impact of bilayer biodegradable synthetic matrix technology (NovoSorb® BTM) on the healing and amputation rates of a diabetic foot ulceration cohort. Consecutive patients with a diabetes-related foot ulceration treated with NovoSorb BTM, between December 2019 and October 2021, were followed for 12 months. Complete wound healing and amputation outcomes were observed. Amputation risk was stratified using the Wound, Ischaemia and foot Infection (WIfI) classification system. Study outcomes were compared with recently published meta-analysis data to evaluate the impact of the synthetic matrix. In total, 25 NovoSorb BTM applications to 23 wounds in 22 patients were observed. Complete wound healing was observed in 15 of the wounds, 3 retained chronic wounds, 3 required minor amputation and 2 required major limb amputation. Further, 12-month WIfI amputation risk analysis saw 18 patients stratified to WIfI stage 4, 4 to WIfI stage 3 and 1 to WIfI stage 1. Our observed 12-month major amputation rates were 11.1% (n = 2) for stage 4 and 0% for stages 3 and 1. Our early experience suggests that NovoSorb BTM is a safe and effective treatment for moderate to severe diabetes-related foot ulceration. While larger-scale data are required, NovoSorb BTM may represent a promising new addition to the armamentarium of clinicians, who strive to achieve limb salvage in this complex cohort of patients.

INTERLEUKINS AND EICOSANOIDS: PATHOGENETIC PATTERNS OF DIABETIC FOOT ULCER

We examined 40 patients with neuropathic (group 1, n=20) and neuroischemic (group 2, n=20) diabetic foot. Before surgical treatment, we studied the content of cytokines (TNF-α, IFN-γ, IL-1β, IL-6 and IL-10) and eicosanoids (LTB4 and PGE2) in the exudate of the ulcer discharge. Pathogenetic mechanisms of inflammation disorders in patients with neuropathic and neuroischemic forms of diabetic foot are different. The neuropathic form is characterized by an increase in the level of TNF-α and IL-6 in the wound exudate, inhibition of the IL-1β and IL-10 secretion, and the predominance of LTB4 in contrast to inhibition of PGE2 synthesis. At the same time, the formation of CD8+ is inhibited as well as the switching of the neutrophilic phase to the macrophage phase by maintaining the conditions for the differentiation of M1 macrophages. In the neuroischemic form, we revealed hyperproduction of IL-1β, IL-10, IFN-γ, CD4+ with inhibition of IL-6 secretion and eicosanoids imbalance (PGE2 prevail over LTB4). This disrupts the differentiation of M2 macrophages. All identified disorders may be due to the persistence of various neutrophil phenotypes in the wound.

Characteristics of Neuropathic, Ischaemic and Neuroischaemic Diabetic Foot Ulcers- A Prospective Cohort Study

Introduction: Diabetic Foot Ulcers (DFU) can be divided into neuropathic, ischaemic and neuroischaemic types. Since the pathophysiology is different, it is important to ascertain the outcome data on the three subgroups of DFU. Aim: To compare and assess the differences in the characteristics and healing process of the three types (Neuropathic, Ischaemic, and Neuroischaemic) of DFU. Materials and Methods: A prospective cohort study was conducted from April 2019 to July 2021 in the Department of Surgery, Regional Institute of Medical Sciences (RIMS) Hospital, Imphal, Manipur, India. Age, gender, duration of diabetes mellitus, smoking, hypertension, glycosylated haemoglobin, aetiology of DFU, osteomyelitis, gangrene, estimated Glomerular Filtration Rate (eGFR), and presence of multiple ulcer were recorded. Healing time and outcome (healed, non healed and amputation) of ulcer were the dependent variable. Data collected were analysed using SPSS-version-21. Fisher’s-exact test was used for proportions. Analysis of the time needed for healing was performed using the Kaplan-Meier method. A p-value of &lt;0.05 was taken as significant. Results: A total of 42 patients were recruited for the study and 29 (69%) were males. Patients in neuropathic, ischaemic and neuroischaemic DFUs were 18,14 and 10, respectively. Hypertension (100%) and smoking history (100%) were present in the ischaemic group. Maximum healing (88.9%) was seen in patient with neuropathic ulcers and maximum non healing (28.6%) and amputation (21.4%) occurred in ischaemic group. Mean (SD) heal time in days were 165.5 (4.62), 141.1 (9.17) and 86.4 (8.02) for ischaemic, neuroischaemic and neuropathic respectively (p&lt;0.001). The average time in which 50% of patients (median) had healed wounds was 75, 136, and 171 days for neuropathic, ischaemic, and neuroischaemic ulcers, respectively. Conclusion: Neuropathic DFU has better healing than the other DFUs. Ischaemic DFU have maximum non heal ulcers and amputation.

Evaluation of tissue perfusion by indocyanine green fluorescein angiography in patients with neuroischemic diabetic foot syndrome after endovascular treatment

To evaluate the fluorescence angiography (FA) parameters with Indocyanine green (ICG) and their dynamics in diabetic foot patients after endovascular treatment. A single-center prospective non-blinded study was conducted with the inclusion of 47 diabetic foot patients with Chronic limb-threatening ischemia (CLTI). TcPO2 and FA-ICG were done before and after angioplasty. Zones of interest were selected for FA-ICG: the area of minimum and maximum fluorescence, the area of of the largest part of the foot. Also presented are the parameters of FA ICG: Tstart (sec) - the time of occurrence of min fluorescence (Istart, unit) in the zone of interest after the introduction of ICG; Tmax (sec) - the time to achieve max fluorescence (Imax, unit) after the introduction of ICG; Tmax -Tstart (sec) - the difference in the time of reaching Imax and Istart. The median TcPO2 values indicated the presence of CLTI before revascularization. Technical success of revascularization was achieved in 45 patients. In the postoperative period, statistically significant changes in TcPO2 and Tstart, Tmax, Tmax-Tstar were obtained. A reduction in the time to reach the ICZ to the zones of interest was noted. FA-ICG evaluate the visual and quantitative characteristics of perfusion of soft tissues of the foot. Reducing the time to reach the fluorescent substance in the areas of interest makes it possible to assume the restoration of the main blood flow to the foot. Further investigations are warranted to determine threshold values to predict wound healing and indications for revascularization.

Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study): An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale.

Cell and/or tissue-based wound care products have slowly advanced in the treatment of non-healing ulcers, however, few studies have evaluated the effectiveness of these devices in the management of severe diabetic foot ulcers. This study (KereFish) is part of a multi-national, multi-centre, randomised, controlled clinical investigation (Odin) with patients suffering from deep diabetic wounds, allowing peripheral artery disease as evaluated by an ankle brachial index equal or higher than 0.6. The study has parallel treatment groups: Group 1 treatment with Kerecis® Omega3 Wound™ versus Group 2 treatment with standard of care. The primary objective is to test the hypothesis that a larger number of severe diabetic ulcers and amputation wounds, including those with moderate arterial disease, will heal in 16 weeks when treated with Kerecis® Omega3 Wound™ than with standard of care. This study has received the ethics committee approval of each participating country. Inclusion of participants began in March 2020 and ended in July 2022. The first results will be presented in March 2023. The study is registered in ClinicalTrials.gov as Identifier: NCT04537520.

A Retrospective Cohort Study on Diabetic Foot Disease: Ascertainment of Ulcer Locations by Age Group.

Background and aimsDiabetic foot ulcer location is a known independent predictor for cure with a better healing gradient proximal to distal. Although advanced age is one of the main factors associated with greater diabetic foot ulcer severity, there are no studies evaluating diabetic foot ulcer location specifically in the elderly population in an outpatient setting. This study evaluated diabetic foot ulcer location and age-group interactions in diabetic foot presentation.MethodsA retrospective cohort study including adult patients with diabetic foot ulcers observed on their first visit to our center's Diabetic Foot Unit in 2018, divided into younger adults (YA) (18 to 64 years) and older adults (OA) (≥65 years).ResultsA total of 435 patients were included in the study with 159 (36.6%) in the YA, and 276 (63.4%) in the OA group.Neuro-ischemic diabetic foot ulcers were more frequent in the OA group (71.4% vs 43.4%, p<0.001). The number of patients with a history of diabetic foot ulcers was lower in the OA group (18.1% vs 25.2%, p=0.03). A smaller proportion of forefoot diabetic foot ulcers (74.9% vs 86.2%, p=0.007) and plantar location diabetic foot ulcers (9.4% vs 24.5%, p<0.001) occurred in the OA group.By univariate logistic regression analysis, we found two associations with older age: proximal (odds ratio (OR) 2.09 (1.23-3.53), p=0.006), and non-plantar (OR 3.13 (1.82-5.37), p<0.001) diabetic foot ulcer location. After adjusting for potential confounders in a multivariate analysis, older age lost the association to more proximal (OR 1.72 (0.94-3.15), p=0.081) and non-plantar (OR 1.78 (0.83-3.77), p=0.133) diabetic foot ulcer location.ConclusionsThere are essential age differences in diabetic foot ulcer presentation. The OA group more frequently presents neuro-ischemic diabetic foot ulcers with more proximal and non-plantar locations.

Therapeutic Alternatives in Diabetic Foot Patients without an Option for Revascularization: A Narrative Review.

Background: The healing of foot wounds in patients with diabetes mellitus is frequently complicated by critical limb threatening ischemia (neuro-ischemic diabetic foot syndrome, DFS). In this situation, imminent arterial revascularization is imperative in order to avoid amputation. However, in many patients this is no longer possible (“too late”, “too sick”, “no technical option”). Besides conservative treatment or major amputation, many alternative methods supposed to decrease pain, promote wound healing, and avoid amputations are employed. We performed a narrative review in order to stress their efficiency and evidence. Methods: The literature research for the 2014 revision of the German evidenced-based S3-PAD-guidelines was extended to 2020. Results: If revascularization is impossible, there is not enough evidence for gene- and stem-cell therapy, hyperbaric oxygen, sympathectomy, spinal cord stimulation, prostanoids etc. to be able to recommend them. Risk factor management is recommended for all CLTI patients. With appropriate wound care and strict offloading, conservative treatment may be an effective alternative. Timely amputation can accelerate mobilization and improve the quality of life. Conclusions: Alternative treatments said to decrease the amputation rate by improving arterial perfusion and wound healing in case revascularization is impossible and lack both efficiency and evidence. Conservative therapy can yield acceptable results, but early amputation may be a beneficial alternative. Patients unfit for revascularization or major amputation should receive palliative wound care and pain therapy. New treatment strategies for no-option CLTI are urgently needed.

Effectiveness of Sucrose Octasulfate Dressing in the Treatment of Neuro-Ischaemic Diabetic Foot Heel Ulcers: A Retrospective Single arm Study.

The study aimed to evaluate the effectiveness of the use of sucrose octasulfate impregnated dressing (TLC-NOSF [Technology Lipido-Colloid-Nano-OligoSaccharide Factor]) in the management of persons with neuro-ischaemic heel diabetic foot ulcers (DFUs). Consecutive patients who referred for an active non-infected neuro-ischaemic heel DFU belonging to grade IC (superficial) or IIC (deep to tendons, muscle or capsule) according to Texas University Classification were included. All patients were managed by a pre-set limb salvage protocol in the respect of International guidelines and the TLC-NOSF dressing was used as primary and specific dressing. Patients were evaluated any 2 to 4 weeks until wound healing or different outcomes. Primary outcome was the rate of complete wound healing after 24 weeks of follow-up. The secondary outcomes assessed the healing time, the rate of wound regression, the re-ulceration in the case of complete healing and the safety. Thirty patients were included. The mean age was 67 ± 11 years, 17 (56.7%) were male, all of them were affected by type 2 diabetes with a mean duration of 18 ± 7 years. Twenty patients (66.7%) showed deep ulcers (grade 2 of Texas University Classification); the mean TcPO2 at the inclusion was 42 ± 7 mm Hg. Twenty-two patients (73.3%) healed by Week 24. The mean time of healing was 84 ± 32 days, 2 (6.7%) patients had ulcer relapse after healing, 28 (93.3%) had wound regression >50%, 2 (6.7%) had mild infection, 1 (3.3%) reported major amputation. No serious adverse events related to TLC-NOSF dressing or local reactions were reported. This current study showed the potential benefit of sucrose octasulfate for treating neuro-ischaemic heel DFUs in addition to the standard of care.

Ultrasonic cavitation in the treatment of neuro-ischemic diabetic foot the presence of biofilm forms of bacteria (literature review)

The constant increase in the number of patients with diabetes mellitus, among whom the incidence of long-term non-healing wounds is many times higher than in the general population, requires constant analysis of treatment protocols and their correction, if necessary. The peculiarities of the wound healing process in the presence of diabetes mellitus include phase perversion and reduced reparative potential. Another problem is the infectious process taking place against the background of diabetes mellitus. Its features include a tendency towards chronicity, frequent persistence of resistant and multiresistive forms of bacteria, and the formation of biofilms. All these factors are pushing to search for new approaches to treatment, and one of the dynamically developing areas is additional treatment of wounds with various types of physical energies. On the one hand, the use of negative pressure, ultrasound, plasma flows, a pulsating jet of liquid, etc. of the wound healing process has been studied for several decades. At the same time, there are still many unanswered problems. One of them is the effectiveness of ultrasonic cavitation in the treatment of purulent-necrotic complications of the neuro-ischemic diabetic foot in the presence of biofilm forms of bacteria in the wound.

Economic Evaluation of Sucrose Octasulfate Dressing for Treatment of Diabetic Foot Ulcers in Patients with Type 2 Diabetes

ObjectivesPatients with noninfected neuroischemic diabetic foot ulcers (DFUs) treated with sucrose octasulfate (SOS) dressing have been shown to have improved healing compared with patients wearing a similar type of dressing without SOS. In this study, we aimed to estimate the cost-effectiveness of SOS dressing compared with conventional dressings from a Canadian public payer’s perspective. MethodsWe built a Markov model in a hypothetical cohort of 1,000 inpatients with type 2 diabetes with DFUs. The time horizon was 5 years, and the cycle length was 3 months. We incorporated effectiveness data from the Explorer trial and cohort studies, cost data (2020 Canadian dollars) from published Canadian studies and administrative databases, and utility parameters from the Alberta’s Caring for Diabetes cohort. We used probabilistic analysis to calculate the incremental cost-effectiveness ratio of SOS dressing compared with conventional dressings. ResultsIn the comparison with conventional dressings, use of SOS dressing resulted in an expected increase of 0.16 quality-adjusted life-year (QALY) and an expected $5,878 decrease in health-care costs over 5 years. Adding SOS dressing resulted in a cost savings of $37,061 for every QALY gained. The probability that adding SOS dressing is cost-saving and cost-effective compared with conventional dressings was 89% and 86%, respectively, at a $50,000/QALY willingness-to-pay threshold. ConclusionsSOS dressing accelerates ulcer healing and helps reduce the spending induced by persistent ulcer management and amputation. Therefore, SOS dressing is likely to be cost-effective and cost-saving, which is consistent with previous health technology assessments in other health-care systems.

Mini-invasive revascularization operations in the complex treatment of neuroischemic and ischemic forms of diabetic foot syndrome

Objective: Diabetic foot syndrome is the most dramatic complication of diabetes mellitus. The treatment success is impossible without improving blood circulation and the elimination of hemodynamic disorders in the affected limb.The study aim was to evaluate mini-invasive revascularization operations effectiveness on the lower limbs peripheral arteries in neuro-ischemic and ischemic diabetic foot syndrome forms.&#x0D; Materials and methods: The study enrolled 104 patients with purulent-necrotic complications of diabetic foot syndrome. 54 (51.9%) patients underwent stenting and balloon angioplasty (the main group). The comparison group included 50 (48.1%) patients, undergoing indirect revascularization surgeries in complex treatment.&#x0D; Results and discussion:After endovascular interventions, the API index increased by 47.6% (p&lt;0.01) after 20 days compared to the admission index, the average blood flow rate increased by 1.8 times (p&lt;0.01), and the tPo2 value improved by 67.8% (p&lt;0.01). In the control group, the tPo2 value increased by 40.3% after 20 days, and API – by 34.4%. In the main group, the swelling disappearance in the foot wounds area was by 3.7±0.5 days faster (p&lt;0.001), wounds purification by 4.1 days (p&lt;0.001), granulation appearance by 3.5±0.4 days (p&lt;0.001), wound margins infiltration disappearance happened 3.3±0.9 days earlier (p&lt;0.001), and the wound epithelization was 2.9 days earlier (p&lt;0.01) than in the control group patients.&#x0D; Conclusion: Foot support function at discharge from hospital was preserved in 94.4% of the main group and in 84% of the control group.&#x0D; Bangladesh Journal of Medical Science Vol.20(4) 2021 p.817-825

Correlation between the level of bacterial load and clinical characteristics of the course of the disease in patients with neuroischaemic diabetic foot

Objective:to analyze the clinical characteristics of the course of the disease in patients with neuroischaemic diabetic foot depending on the presence of bacterial monocultures and associations in wounds.Material and methods.We have performed a comparative analysis of the parameters of the clinical course of the disease and the condition of patients’ wounds (n = 76) depending on the presence of monocultures (group 1, n = 32) and microbial associations (n = 42). The list of the compared parameters in the groups included the duration of diabetes, number of hospitalizations per year, achievement of target HbA1c levels (&lt;7.5 %), condition of granulation tissue of wounds.Results.With increased duration of the course of diabetes (from 5 to 15 years), higher number of hospitalizations per year, deteriorated carbohydrate metabolism (HbA1c&gt; 7.5%) in combination with clinical signs of the initial stages of wound infection, the frequency rate of the detection of mixed bacterial cultures increased.Conclusion.The work has found differences in the duration of the course of diabetes, the number of hospitalizations per year, local status of wounds in the patients, as well as the frequency of achieving the target levels of HbA1с &lt;7.5 %, depending on the severity of microbial load.

Quantifying dermal microcirculatory changes of neuropathic and neuroischemic diabetic foot ulcers using spatial frequency domain imaging: a shade of things to come?

IntroductionThe use of non-invasive vascular and perfusion diagnostics are an important part of assessing lower extremity ulceration and amputation risk in patients with diabetes mellitus. Methods for detecting impaired microvascular...

Increasing Transcutaneous Oxygen Pressure in Patients With Neuroischemic Diabetic Foot Ulcers Treated With a Sucrose Octasulfate Dressing: A Pilot Study.

Regarding the positive clinical outcomes of sucrose octasulfate impregnated dressing documented in neuroischemic diabetic foot ulcers (DFUs), we aimed to evaluate the microcirculatory status in patients with neuroischemic DFU through the use of sucrose octasulfate dressing. Eleven patients with neuroischemic DFU were included in a prospective pilot study between July 2019 and March 2020. We evaluated the effect in transcutaneous oxygen pressure (TcPO2; mm Hg) values within the use of a sucrose octasulfate dressing in the course of the healing process of neuroischemic DFUs (UrgoStart Contact, Laboratoires Urgo Medical). TcPO2 values were assessed at day 0 and monthly until wound healing was achieved. Additionally, wound healing process was evaluated using the Wollina score system and wound area surface, at day 0 and monthly until 20 weeks of follow-up or wound healing first occurred. TcPO2 values showed a significant increase between day 0 (29.45 ± 7.38 mm Hg) and wound closure (46.54 ± 11.45 mm Hg, P = .016), after dressing application. Wollina wound scores showed a significant improvement (4.2 ± 1.7 at day 0 to 5.4 ± 1.3 at the end of the study; P = .004). Median wound area at day 0 was 1.30 cm2, interquartile range [1.60-1] cm2, and 0.5 cm2 at week 4, interquartile range [1.1-0.1], P < .001. Median healing time was 8 weeks, interquartile range [8-5]. Treating a neuroischemic DFU with a sucrose octasulfate dressing in the standard of care showed an increase in skin oxygen pressure.