Charcot Neuro-Osteoarthropathy With Superimposed Osteomyelitis in a Nondiabetic Patient, as a Consequence of Cancer Chemotherapy: A MR-Monitored Case Report.

Charcot neuro-osteoarthropathy (CNO) is a manifestation of peripheral neuropathy as a chronic complication of diabetes mellitus but, less frequently, can be associated to other conditions such as alcoholism or neurotoxic therapies. An increasingly emerging cause of CNO is the use of oncological drugs which can cause neuropathic damage. The use of these therapies dramatically increased in recent years. CNO leads to a progressive degeneration of the foot's joints and to bone destruction and resorption which ends in deformities. These alterations in the foot's anatomy determine a high risk of ulceration, infection, and osteomyelitis. The superimposition of osteomyelitis on CNO increases the risk of major amputation, already high in patients suffering either from only CNO or osteomyelitis alone. We report the case of a 61-year old nondiabetic woman affected by CNO as a consequence of antiblastic therapy for breast cancer and the subsequent overlap of osteomyelitis, confirmed by magnetic resonance imaging. This case underlines how it is necessary to consider CNO as a possible complication of antiblastic therapy in the view of the severe consequences of missing its diagnosis.

Higher Prevalence of Cancer in Patients with Diabetic Foot Syndrome.

Background: Diabetes mellitus (DM) is associated with a higher prevalence of many forms of cancer. Diabetic foot syndrome (DFS) is associated with higher risk of lower limb amputation and mortality not all explainable with a cardiovascular profile at greater risk compared with DM patients without DFS. DFS could be associated with an increasing cancer incidence. To explore a possible link between DFS and cancer, comparing two cohorts of patients (DFS+ and DFS-) with a cohort of superimposable non-DM controls. Methods: We retrospectively analysed the databases of our department for all consecutive patients admitted between January 2019 and December 2021, selecting all DM pts, and sorting DFS+ pts, admitted for foot complications, from DFS- ones, admitted for other reasons. Cases of pancreatic cancer as well as cancer-related admissions were excluded. Patients were compared to non-DM patients admitted for non-oncological medical problems. The primary endpoint was to compare the prevalence of cancer among the groups, while the secondary endpoint was to look for predictors for cancer in the groups studied. Results: A cohort of 445 consecutive DM inpatients (222 DFS+ and 223 DFS-) and 255 controls were studied. Cancer prevalence in DFS+ group was significantly higher than in DFS- (p = 0.008) and controls (p = 0.031), while no differences were observed between DFS- and the controls. Univariate regression analysis showed a significant association between cancer and DFS (p = 0.007), age at admission (p ≤ 0.001), years of diabetes (p = 0.017) and haemoglobin concentration [Hb] (p = 0.030). In the multivariate regression analysis with DFS, age at admission and [Hb], only DFS (p = 0.021) and age at admission (p ≤ 0.001) persisted as independent factors associated with cancer. Conclusions: A higher prevalence of cancer in DFS+ patients than in DFS- patients and non-diabetic controls is reported. DFS and age can both be considered independent predictors of cancer in patients with DM.

In blood we trust: anemia as a negative healing prognostic factor in diabetic foot patients.

AIM: Anemia has been associated with severity of diabetic foot (DF) disease. Our study aimed to evaluate whether the presence of anemia could decrease the healing chances in DF. METHODS: We retrospectively analyzed all patients admitted in our department in 2021 for DF, dividing them according to presence (Group A) or absence (Group B) of anemia. Groups were compared for clinical and demographic characteristics, procedures and outcomes: healing rate (HR) at 6 months, healing time (HT) and recurrence rate (RR) at 12 months. RESULTS: We sorted out data from 196 consecutive patients: 114 (58%) in Group A and 82 (42%) in B. Group A had a higher male prevalence and a longer duration of disease. Group A showed lower hemoglobin concentration (10.3 ± 1.3 g/dL vs 13.1 ± 1.4 g/dL, p < 0.002) and red blood cells count (3.4 ± 0.5 × 106/mL vs 4.8 ± 0.6 × 106/mL, p = 0.004). Group A presented a lower HR (55.2% vs 76.8%, p = 0.0028), no differences in HT and a higher RR (23.6% vs 17.1%, p < 0.02). Cox's logistic regression on healing confirmed the negative impact of anemia: hazard ratio 2.8 (CI 95% 1.4-5.4, p = 0.0037). CONCLUSIONS: Anemia is frequent in DF and associates to a reduction in healing chances and an increase in recurrences representing an independent predictor of healing failure.

Peripheral Interventional Strategy Assessment (PISA) for Diabetic Foot Ulcer Revascularization: Preliminary Outcomes of a Multidisciplinary Pilot Study.

BACKGROUND: Digital subtraction angiography (DSA) still represents the gold standard for anatomical arterial mapping and revascularization decision-making in patients with chronic limb-threatening ischemia (CLTI), although DUS (Doppler Ultrasound) remains a primary non-invasive examination tool. The Global Vascular Guidelines established the importance of preoperative arterial mapping to guarantee an adequate in-line flow to the foot. The aim of this study was to evaluate the accuracy of DUS in guiding therapeutic vascular treatments on the basis of Global Vascular Guidelines without the need of a second-level examination. METHODS: Between January 2022 and June 2022, all consecutive patients with CLTI to be revascularized underwent clinical examination and DUS without further diagnostic examinations. Primary outcomes assessed were technical success, and 30-day mortality. Secondary outcomes were 1-year amputation free survival, and time between evaluation and revascularization. RESULTS: Sixty-eight patients with a mean age of 73.6 ± 8.5 years underwent lower limb revascularization. Technical success was 100%, and the 30-day mortality rate was 2.9%. Mean time between evaluation and revascularization was 29 ± 17 days. One-year amputation free survival was 97.1%. CONCLUSIONS: DUS without further diagnostic examinations can accurately assess the status of the vascular tree and foot runoff, providing enough information about target vessels to guide revascularization strategies.

Validation of the Fast-Track Model: A Simple Tool to Assess the Severity of Diabetic Foot Ulcers.

This study aimed to validate the association between the grades of severity of diabetic foot ulcers (DFUs) identified by the fast-tack model and specific outcomes. Three hundred and sixty-seven patients with new DFUs who were referred to a tertiary level diabetic foot service serving Rome, Italy, were included. The fast-track model identifies three levels of DFUs' severity: uncomplicated DFUs, including superficial wounds, not-infected wounds, and not-ischemic wounds; complicated DFUs, including ischemic wounds, infected wounds, and deep ulcers involving the muscles, tendons, or bones, and any kind of ulcers in patients on dialysis and/or with heart failure; and severely complicated DFUs, including abscesses, wet gangrene, necrotizing fasciitis, fever, or clinical signs of sepsis. Healing, minor and major amputation, hospitalization, and survival after 24 weeks of follow-up were considered. Among the included patients, 35 (9.6%) had uncomplicated DFUs, 210 (57.2%) had complicated DFUs, and 122 (33.2%) had severely complicated DFUs. The outcomes for patients with uncomplicated, complicated, and severely complicated DFUs were as follows, respectively: healing, 97.1%, 86.2%, and 69.8%; minor amputation, 2.9%, 20%, and 66.4%; major amputation, 0%, 2.9%, and 16.4%; hospitalization, 14.3%, 55.7%, and 89.3%; survival, 100%, 96.7%, and 89.3%. DFU severity was an independent predictor of healing, amputation, hospitalization, and survival. The current study shows an association between the grade of severity of DFUs identified by the fast-track model and the considered outcomes. The fast-track model may be a useful tool for assessing the severity and prognosis of DFUs.

Necrotizing Fasciitis and Diabetic Foot: Results of a Prompt Identification, Surgery and Antibiotic Therapy (P.I.S.A.) Protocol.

Necrotizing fasciitis (NF) is a rapidly progressive, life-threatening infection, involving the skin, soft tissue and fascia. We evaluated outcomes of its surgical management in diabetic foot (DF) patients in a tertiary referral centre. We retrospectively searched for NF in the database of our DF Section from 2016 to 2018. All cases were treated according to a multiprofessional integrated protocol, with Prompt Identification, Surgical debridement and systemic Antibiotic therapy (P.I.S.A. Protocol). We analysed short-term evolution (surgical procedures and major amputations), and long-term outcomes (survival and healing rates). Sixty-eight patients were referred to our DF clinic for suspicion of NF. The diagnosis was confirmed in 54 (79.4%; male/female 40/14; type 1/2 diabetes 6/48; age 62.8 ± 8.1 years; duration of diabetes 13.6 ± 10.1 years). According to the microbiological results, cases were classified as Type 1 (33-61.2%), 2 (7-12.9%) and 3 (14-25.9%). No significant differences were observed. All patients underwent a decompressive fasciotomy. Six patients (11.1%) required also a forefoot amputation and 12 (22.2%) a toe or ray amputation. No major amputation was performed in the short-term period. During the follow-up (26 ± 12 months) 46 patients (85%) healed in 94 ± 11 days. Of the remaining 8: 5 (9.2%) died for other reasons before healing, 2 (3.7%) recurred and one (1.9%) required a major amputation. Our experience reveals a relatively high prevalence of NF in DF; despite this, we observed how, when promptly and aggressively treated, NF has a good prognosis and it is not associated with an excess of limb loss and deaths.

The Weakness of the Strong Sex: Differences Between Men and Women Affected by Diabetic Foot Disease.

We aimed to analyze sex-related differences in clinical outcomes among patients with diabetic foot disease (DFD) managed in a third-level referral center. We retrospectively analyzed data of admissions performed in our department between 2011 and 2015 for DFD. We collected demographic and clinical data, procedures performed during the admission, and short- and long-term outcomes in terms of healing rate and healing time, major amputation, and mortality rates during the follow-up. We focused on differences between genders and tried to figure out if sex could be considered a predictive factor. We collected data from 1237 admission performed in 842 patients (615 men [73%] and 227 women [27%]; age: 68.6 ± 27.9 years; diabetes duration: 16.4 ± 13.4 years; body mass index: 28.2 ± 6.4 kg/m2; hemoglobin A1c 7.9 ± 1.9%). Men showed a higher prevalence of comorbidities and previous ulcers or revascularization procedures. Men had a significantly higher healing rate compared with women (85.4% vs 63.2%, P < .001), but a longer healing time (124 ± 27 days vs 87 ± 14 days, P = .02). Major amputation did not differ between groups, while mortality rate was significantly higher in men (24.5% vs 16.1%, P = .02). In Cox's regression analysis, male sex was a positive predictive factor for healing and a negative one for time to heal and mortality. The difference in mortality was confirmed by a Kaplan-Meier analysis (log rank test: P = .03). DFD represents a severe disease and a strong marker of mortality affecting more severely on clinical outcomes and survival on men.

Type 2 diabetes mellitus and obesity: The synergistic effects on human locomotor function.

BACKGROUND: Diabetes Mellitus and obesity represent two chronic multifactorial conditions which may induce modifications in human motion strategy. Our study focused on gaining insight into biomechanical aspects of gait occurring in patients affected by both aforementioned pathologies. METHODS: One hundred subjects were recruited and divided into four groups: 25 obese-diabetic patients with peripheral neuropathy; 25 obese non-diabetic patients; 25 non-obese diabetic patients with peripheral neuropathy; 25 healthy volunteers participated as a control group. Subjects performed 3-D Gait Analysis while walking barefoot at self-selected speed, performing three consecutive trials. A multivariate analysis of variance test was used to assess spatio-temporal and kinematic data difference in the four groups. Tukey's post-hoc adjustment was applied on multiple groups' comparison. FINDINGS: Diabetic-obese subjects showed increased step width compared to controls, while step and stride length, and walking velocity were reduced. Interestingly, step width presented increased values even compared to diabetic patients. Kinematics data showed a significant reduction in ankle plantarflexion during the push-off phase of the gait cycle compared to controls, and to obese subjects. Furthermore, knee kinematics revealed a reduced peak flexion during the swing time of the gait cycle, compared to controls and diabetic subjects, which resulted in reduced knee dynamic excursion during normal walking compared to healthy subjects. INTERPRETATION: Our data demonstrated that diabetic-obese subjects present gait features typical of both such pathologies. The specific impairment of ankle and knee joint kinematics provides evidence of a synergistic effect of Diabetes Mellitus type 2 and obesity on human ambulatory function.

Pilot Experience on the Use of S53P4 Bioactive Glass in the Surgical Management of Diabetic Foot Osteomyelitis.

To test safety and efficacy of bioactive glass, a novel material used to replace bone, able to completely bond itself to the host tissues on patients treated for osteomyelitis (OM) complicating a diabetic foot (DF). We evaluated a group of patients consecutively admitted in our department between September and December 2018, who underwent surgical DF procedures for OM and in whom the use of bioactive glass could limit the demolition phase of surgical procedure. Patients were treated with bioactive glass S53P4 on top of standard treatment directly in operating room. The patients were weekly controlled for 6 months or until complete healing. During follow-up, we analyzed primarily healing rate and secondarily time of healing, need for further debridement procedures, recurrences, and adverse or hypersensitivity reactions to study treatment. Ten DF patients were enrolled (male/female 6/4; mean age 56 ± 11 years; mean duration of diabetes 10.5 ± 4.7 years, mean hemoglobin A1c 7.2 ± 0.9%). Patients underwent surgical procedure during which, after an accurate debridement, bioactive glass was applied. A healing rate of 80% in a mean time of 34 ± 2 days, with only 1 patient who needed a second surgical look, was observed. Neither recurrences nor adverse events during follow-up were observed in treated patients. This pilot experience demonstrated that bioactive glass can be considered a useful tool for the surgical treatment of DF-related OM.

Characteristics of new patient referrals to specialised diabetic foot units across Europe and factors influencing delays.

OBJECTIVE: Foot ulcers are a common complication of diabetes and are associated with an increase in lower limb amputation and death. Early referral to a specialised unit is recommended. The aim of this study was to assess the characteristics of new-patient referrals to specialised diabetes foot care units across Europe and to determine the factors involved in delayed referral. METHOD: In this prospective observational study, consecutive patients with a new foot ulcer presenting to nine diabetic foot centres in five European countries (France, Germany, Italy, Spain and the UK) were included. RESULTS: Some 25% of the 332 patients included had presented with a foot ulcer >3 months before referral to the participating foot clinic. Compared with patients referred earlier, patients with a long time to referral (>3 months) were older (p=0.006) and had a less severe wound according to Infectious Diseases Society of America (IDSA) classification (p=0.003) and University of Texas classification (grade D=infection + peripheral artery disease, p=0.004). CONCLUSION: The proportion of patients with a diabetic foot ulcer (DFU) referred to a specialised unit >3 months after the beginning of the ulcer remained high throughout Europe. Patients with severe DFU were, however, referred more quickly by front line health professionals. Primary care professionals need to be made aware of the importance of early referral to a specialised unit in order to improve the management of foot disease in patients with diabetes. DECLARATION OF INTEREST: The authors have no conflicts of interest to declare.

Effectiveness of fast-track pathway for diabetic foot ulcerations.

AIM: To investigate the effectiveness of fast-track pathway (FTP) in the management of diabetic foot ulceration (DFU) after 2 years of implementation. METHODS: The study group was composed of patients who referred to a specialized DF centre due to DFUs. Those were divided in two groups: early referral (ER) and late referral (LR) patients. According to FTP, ER were considered patients who referred after 2 weeks in the case of uncomplicated non-healing ulcers (superficial, not infected, not ischemic), within 4 days in the case of complicated ulcers (ischemic, deep, mild infection) and within 24 h in the case of severely complicated ulcers (abscess, wet gangrene, fever). Healing, healing time, minor and major amputation, hospitalization, and survival were evaluated. The follow-up was 6 months. RESULTS: Two hundred patients were recruited. The mean age was 70 ± 13 years, 62.5% were male, 91% were affected by type 2 diabetes with a mean duration of 18 ± 11 years. Within the group, 79.5% had ER while 20.5% had LR. ER patients showed increased rates of healing (89.9 vs. 41.5%, p = 0.001), reduced healing time (10 vs. 16 weeks, p = 0.0002), lower rates of minor (17.6 vs. 75.6%, p < 0.0001) and major amputation (0.6 vs. 36.6%, p < 0.0001), hospitalization (47.1 vs. 82.9%, p = 0.001), and mortality (4.4 vs. 19.5%, p = 0.02) in comparison to LR. At multivariate analysis, ER was an independent predictor of healing, while LR was an independent predictor for minor and major amputation and hospitalization. CONCLUSION: After the FTP implementation, less cases of LR were reported in comparison to ER. ER was an independent predictor of positive outcomes such as healing, healing time, limb salvage, hospitalization, and survival.

Effect of Direct Endovascular Revascularization Based on the Angiosome Model on Risk of Major Amputations and Life Expectancy in Type 2 Diabetic Patients with Critical Limb Ischemia and Foot Ulceration.

BACKGROUND: We evaluated whether direct or indirect endovascular revascularization based on the angiosome model affects outcomes in type 2 diabetes and critical limb ischemia. METHODS: From 2010 to 2015, 603 patients with type 2 diabetes were admitted for critical limb ischemia and submitted to endovascular revascularization. Among these patients, 314 (52%) underwent direct and 123 (20%) indirect revascularization, depending on whether the flow to the artery directly feeding the site of ulceration, according to the angiosome model, was successfully acquired; 166 patients (28%) were judged unable to be revascularized. Outcomes were healing, major amputation, and mortality rates. RESULTS: An overall healing rate of 62.5% was observed: patients who did not receive percutaneous transluminal angioplasty presented a healing rate of 58.4% (P < .02 versus revascularized patients). A higher healing rate was observed in the direct versus the indirect group (82.4% versus 50.4%; P < .001). The major amputation rate was significantly higher in the indirect versus the direct group (9.2% versus 3.2%; P < .05). The overall mortality rate was 21.6%, and it was higher in the indirect versus the direct group (24% versus 14%; P < .05). CONCLUSIONS: These data show that direct revascularization of arteries supplying the diabetic foot ulcer site by means of the angiosome model is associated with a higher healing rate and lower risk of amputation and death compared with the indirect procedure. These results support use of the angiosome model in type 2 diabetes with critical limb ischemia.

I fear COVID but diabetic foot (DF) is worse: a survey on patients' perception of a telemedicine service for DF during lockdown.

AIMS: To evaluate the patients' perceptions of telemedicine visits during COVID-19 lockdown and their level of anxiety about COVID and diabetic foot (DF). METHODS: In May 2020, we contacted by phone all the patients who underwent in March and April to remote monitoring visits for DF during the lockdown for COVID-19, with a structured interview, focusing on their perceptions about telemedicine service for DF and on the anxiety toward COVID and DF. RESULTS: We analyzed 257 remote monitoring visits in 211 patients. Two hundred and six patients answered the follow-up interview; 177 patients (85.9%) remembered the monitoring visit, 140 (67.9%) the health care professional and 181 patients (87.9%) the reason of contact; 169 patients were alone during the visit, 37 with a relative. Patients judged useful both the monitoring during pandemic (4.35 ± 0.28 on a maximum of five) and the possibility to continue after the lockdown (4.34 ± 0.23 on a maximum of five). Eventually, we observed that DF patients were more worried by DF than by COVID on a scale from 0 (not fear at all) to 5 (terrified) (4.79 ± 0.05 vs. 3.27 ± 1.03, p < 0.05). This difference was higher in previously ulcerated patients (4.84 ± 0.03 vs. 3.03 ± 1.13, p < 0.05) and even more in amputees (4.93 ± 0.03 vs. 2.73 ± 1.21, p < 0.05). CONCLUSIONS: DF patients appreciated televisits during lockdown and the continuation of this service after its end. In this context DF prevails on COVID in the worries of patients, especially if they are recurrent ones.

Bioactive Glass in a Rare Case of Osteomyelitis of the Heel in a Guillain-Barré Syndrome: A Case Report.

Guillain-Barré syndrome (GBS) represents an acute inflammatory immune-mediated demyelinating polyradiculoneuropathy with an incidence of 0.6 per 100 000 people. In this article, we report the case of a 19-year-old girl affected by GBS since the age of 2 who presented at our clinic complaining for a chronic plantar hindfoot-infected ulceration. Serology showed increase of inflammatory markers and leukocytosis, and magnetic resonance imaging revealed osteomyelitis of calcaneum and soft tissue alterations with air bubbles. The patient was treated in our clinic by an integrated multidisciplinary approach consisting of immediate admission, soft tissue and bone debridement, and administration of antibiotics under the close control of infectious disease specialist. After the control of acute condition, the patient underwent negative pressure therapy associated with instillation of antiseptic solution until the restoration of bone and soft tissue loss of substance and, eventually, to the application of bioactive glass substitute until the achievement of complete wound healing.

Ultrasound in the Modern Management of the Diabetic Foot Syndrome: A Multipurpose Versatile Toolkit.

Ultrasound (US) is a noninvasive and versatile technology that in recent years found acceptance in almost all the medical specialties, with diagnostic and interventional applications. In the diabetic foot syndrome (DFS), US found specific indications mainly in the screening, quantification, and follow-up of the vascular component of the pathology, but also in the study of the deformities and structural modifications induced by neuropathy and in the diagnosis and surgical management of infections, especially those that induce anatomical changes, like abscesses and fasciitis. This review will summarize all these application of US, giving special attention to the vascular aspects, and on the predominant role that US gained in recent times to guide the indication to revascularization, on the new standardized approach to the study of the arterial tree of the limb and the foot, the so-called duplex ultrasound arterial mapping, which significantly increased the utilization of US to plan the revascularizations in this complex pathology. Outside the vascular fields, the diagnosis of neuropathy and infection and the intraoperative use of US in the surgical management of abscesses and fasciitis will be discussed, leaving the last part to the new and interesting applications of US in the management of DFU, a field that is still in evolution, offering new possibilities to the health care professionals involved in the management of these chronic wounds. The variety of applications both in diagnostic and operative fields makes US a rather versatile technology-a toolkit-that should have a special place among those at reach of the specialists of DFS care.

Diabetic foot surgery "Made in Italy". Results of 15 years of activity of a third-level centre managed by diabetologists.

AIM: To evaluate clinical outcomes in patients who underwent diabetic foot surgery (DFS) managed directly by diabetologists in a third-level Centre over 15-year. METHODS: We retrospectively evaluated 1.857 patients affected by diabetic foot (Age 67.1 ± 12.3 yrs, diabetes duration 19.2 ± 9.8 yrs, HbA1c 8.1 ± 2.0%) treated in our Department between 2001 and 2015 and divided them into 3 groups: Group 1, treated between 2001 and 2005 (448 pts), group 2, between 2006 and 2010 (540 pts) and Group 3, between 2011 and 2015 (869 pts). Main clinical outcomes [peripheral revascularization rate (PR), healing rate (HR), healing time (HT), recurrences after healing (R), major amputation (MA) and death (D) rates] were compared between groups. RESULTS: The overall outcomes of our cohort were: HR 81.6% (HT 143 ± 54 days), PR 84.8%, MA 4.9% and D 27.9%. There were no differences in clinical characteristics, except for age, higher (p < 0.05) in Group 3 (70.6 ± 14.7 yrs) than in Groups 1 (64.4 ± 11.6 yrs) and 2 (65.1 ± 11.2 yrs). No differences emerged when comparing HR and MA; HT was shorter (p < 0.05) in group 3 (104 ± 44 days) than in Group 2 (169 ± 72 days) and 1 (235 ± 67 days). D was higher (p < 0.05) in Group 3 (43.8%) than in Group 1 (23.1%) and 2 (28.1%). PR was 19.4% in Group 1, 28.1% in Group 2 and 53.8% in Group 3 (p < 0.05). CONCLUSIONS: Despite the increasing age and complexity of patients our data show improvement of outcomes throughout 15 years, probably due to better surgical techniques, more aggressive medical therapy and more effective treatment of critical limb ischemia.

Using Skin Bioengineering to Highlight How Weight and Diabetes Mellitus Modify the Skin in the Lower Limbs of Super-Obese Patients.

AIM: To evaluate the distinct contribution of obesity and diabetes (DM) to the skin modification in metabolic diseases. METHODS: We analysed all patients admitted for bariatric surgery in our hospital with BMI between 38 and 47 kg/m2, with (Group 1) or without (Group 2) DM and compared them with a group of nonobese diabetic patients (Group 3) and healthy volunteers (Group 4). The following features were evaluated: hardness, temperature, hydration and thickness alongside with anthropometric measures of foot and leg. RESULTS: For the general characteristics, patients differed in age and body mass index. As predictable all circumferences (dorsal foot, sovramalleolar and under the knee) were significantly higher in obese with no differences depending on DM (all parameters: p<0.01 in Group 1 and Group 2 vs Group 3 and Group 4). Skin temperature was significantly higher in all obese, irrespectively from the presence of DM (1st metatarsal head: p=0.02 Group 1 and Group 2 vs Group 3 and Group 4; 5th metatarsal head: p<0.01 in Group 1 and Group 2 vs Group 3 and Group 4). Skin hydration score showed increased anhydrosis in both diabetics and severe obesity (p<0.01 in Group 1 and Group 3 vs Group 2 and Group 4). Increase in thickness of skin and subcutaneous tissues was observed (at heel: p<0.01 in Group 1 and Group 2 vs Group 3 and Group 4 and under the scaphoid p=0.03 Group 1 and Group 2 vs Group 3 and Group 4) and plantar fascia (in both regions p=0.02 Group 1 and Group 2 vs Group 3 and Group 4) in all obese patients, with or without DM. CONCLUSION: Severe obesity significantly affects both shape and structure of the foot, possibly exposing these patients to a higher risk of biomechanical stress. On such a background DM, modifying skin hydration and protective mechanisms exerts a synergistic role further increasing the risk of trauma and ulcers.

Adherence to guideline recommended medical therapies in type 2 diabetic patients with chronic critical limb ischemia.

AIM: The aim of this study was to evaluate the adherence to guideline recommended medical therapies in type 2 diabetic patients with chronic critical limb ischemia (CCLI). METHODS: We retrospectively analyzed the data of 1315 admissions performed in our Department, focusing on diabetic foot patients (842-64%) of which 603 consecutive type 2 diabetic patients with CCLI (M/F(%): 73/27; age: 70.3 ±â€¯10.4 yrs; diabetes duration: 17.3 ±â€¯13.7 yrs; BMI: 27.7 ±â€¯5.3 Kg/m2; HbA1c 7.8 ±â€¯1.8%) referred to a third-level Center from 2011 to 2015. We focused on medical therapy of diabetes, dyslipidemia, hypertension, peripheral vascular disease and smoke habits. RESULTS: In total, at admission, 66.6% of patients had HbA1c levels higher than recommended; 65.9% of patients were on statins; 81.4% on anti-hypertensive treatment and 72.4% on antiplatelet drugs. Concerning smoke habits, 27% of patients were no-smokers; 41% former smokers and 32% active smokers. Among all patients, only 24% were prescribed all five guideline recommended therapies while 32% reached four out of five of these. As for patients treated with anti-hypertensive drugs, we observed higher levels of systolic pressure (138.0 ±â€¯29.5 vs 107.7 ±â€¯36.6 p < 0.02) while no differences were observed in diastolic pressure levels. CONCLUSIONS: In conclusion, when it comes to diabetic patients with a severe limb and life threatening clinical condition, we noticed a lower-than-expected application of international guideline-recommended medical therapies. In fact, only one out of four patients was following all the recommended therapies. Nevertheless, these patients did not reach the standard targets requested to prevent cardiovascular disease.

Evaluation of fluorescence biomodulation in the real-life management of chronic wounds: the EUREKA trial.

OBJECTIVE: Fluorescence biomodulation (FB), a form of photobiomodulation (PBM) that is also known as low energy level light (LELL), has become an increasingly used clinical tool to induce wound healing in wounds that remain recalcitrant to treatment. In a real-life clinical setting, the aim of the EUREKA (EvalUation of Real-lifE use of Klox biophotonic system in chronic wound mAnagement) study was to confirm the efficacy and safety of LumiHeal, a system based on FB, in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs) and pressure ulcers (PUs). The effects of this FB system on the modulation of wound healing in chronic ulcers through FB induction were previously examined in an interim analysis of this study. METHOD: A multicenter, prospective, observational, uncontrolled trial in 12 clinical sites in Italy. The wound was cleansed with saline and a 2mm thick layer of a chromophore gel was applied to the affected area in a biweekly regimen. The area was then illuminated with the LED activator for five minutes at a distance of 5cm. Treatment was used in combination with standard of care specific to each type of chronic wound (VLU, DFU, PU). Wound area evaluation was assessed using the Silhouette Imaging System and quality of life (QoL) with the Cardiff Wound Impact Schedule (CWIS). A seven-point evaluation of the clinicans' view was also examined. RESULTS: We enrolled 100 subjects, with the final analysis including 99 patients/ulcers consisting of 52 VLUs, 32 DFUs and 15 PUs. Total wound closure at the end of the study was achieved in 47 patients by aetiology: 26 VLUs (50% of VLUs); 16 DFUs (50% of DFUs); and five PUs (33.3% of PUs). The mean wound area regression at last study assessment was significant for VLUs (41.0%; p<0.001) and DFUs (52.4%; p<0.001). After four weeks of treatment, it was possible to significantly predict if the ulcer would respond (defined as a decrease of wound size) to the study treatment. Adherence was high (95.2%) and no related serious adverse events were reported during the study. QoL significantly improved, with an increase of 15.4% of the total score, using the CWIS (p<0.001). CONCLUSION: The study confirmed a positive efficacy profile of the FB system in inducing the wound healing process in three different types of hard-to-heal chronic wounds. The treatment was shown to be safe and well tolerated by the patients, with a significant improvement in patient QoL. This approach offers an effective modality for the treatment of hard-to-heal chronic ulcers.