Valitrack study: Objective evaluation of medical compression wearing time and patient activity with the Accutrack® by Sigvaris Group sensor.

INTRODUCTION: Objective measurement of compliance is mandatory to evaluate therapeutic effects and clinical benefits of medical compression stockings. This Valitrack study evaluates the Accutrack sensor equipped with an accelerometer. The evaluation is done under controlled and free conditions and during washing. RESULTS: Global accordance results are excellent: Sensitivity (98.6%) and specificity (95.2%) and 92% of patients are not disturbed by the sensors when putting on the stockings. DISCUSSION: Thanks to its specificities one sensor per patient is sufficient. Its sensitivity distinguishes still and active positions. Only hand washing remains a false positive. The Accutrack sensor objectively measures compliance and will not be a bias because 96% of patients forget it. CONCLUSIONS: Objective compliance measurement with Accutrack allows us to evaluate the efficacity of compression, the reasons of non-compliance, and the patient's actual physical activity according to its accelerometer time-stamped.

Effect of foot stato-dynamic disorders on hemodynamics of the lower limb using strain-gauge plethysmography.

BACKGROUND: The plantar venous pump (PVP), composed of deep plantar veins, is the most distal contributor to venous return from the lower limbs. A pressing need still exists to assess how plantar muscle contraction and gait affect PVP function, how foot stato-dynamic disorders (FSDs) can contribute to venous insufficiency, and how venous return can be optimally stimulated. Our first objective is to compare the venous blood hemodynamics in lower limbs between healthy subjects with a FSD and healthy subjects without a FSD to understand the influence of foot morphology in the performance of the PVP. Our second objective is to evaluate whether PVP function varies with different plantar pressures. METHODS: A total of 52 healthy volunteers (26 feet with a normal arch as the control group and 26 feet with dysmorphism [13 flat feet and 13 hollow feet]) were included. Strain-gauge plethysmography was performed 8 cm above the medial malleolus at different conditions of PVP stimulation: (1) toe flexion, (2) intermittent pneumatic compression (IPC) with and without an insole, and (3) 3-km/h speed walking on a treadmill barefoot, with shoes, and with shoes and insoles. From the strain-gauge plethysmography, we measured the venous blood ejection fraction (EF). From the pressure sensor placed at the midfoot on the plantar arch during IPC, we obtained the maximal pressure (N/cm2). RESULTS: Toe flexion allowed for ejection of an average of 20% of the total venous volume in both groups. IPC and gait generated a mean EF superior to 100% of the available venous volume. The maximal pressure applied at the midfoot during IPC was lower than the pressure set. No significant differences in the EF or maximal pressure were observed between the two groups. The mean EF was not significantly affected for the pronator and supinator walkers compared with those with normal walking dynamics. Wearing shoes did not significantly affect the mean EF. However, wearing insoles during gait significantly increased the venous return in feet with plantar dysmorphism. CONCLUSIONS: To the best of our knowledge, this clinical study is the first to assess the PVP function in 52 healthy volunteers with and without FSDs. We found that wearing shoes did not significantly affect PVP efficiency but that wearing morphologically adapted insoles significantly improved the venous return in the dysmorphic feet. In our sample of healthy volunteers, the differences observed between the control group and feet with FSDs were not statistically significant.

Effect of dysmorphic plantar arch on venous hemodynamics of the lower limb.

BACKGROUND: The role of the plantar venous pump (PVP) on venous return is evident but the effects of the foot morphology have never been characterized properly. METHOD: 52 healthy volunteers-26 with normal plantar arch (control) and 26 with dysmorphic plantar arch (in two subgroups: 13 flat feet, 13 hollow feet)-were included. Using Doppler ultrasound, we measured the diameter and the peak systolic velocity in the large veins of the lower limb after PVP stimulation by manual compression and bodyweight transfer. RESULT: The mean peak systolic velocity of the studied veins varied from 12.2 cm/s to 41.7 cm/s in the control group and from 10.9 cm/s to 39.1 cm/s in the dysmorphic plantar group. The foot arch morphology did not affect significantly the venous blood flows, except in the great saphenous vein during manual compression. CONCLUSION: The plantar morphology did not induce a significant increase of venous blood velocity resulting from PVP stimulation.

Fatigue, physical activity, and quality of life in people self-reporting symptoms of chronic venous disease.

OBJECTIVE: The aim of this study was to quantify fatigue and quality of life (QoL) in people self-reporting chronic venous disease (CVD) symptoms or at risk of CVD within a large cohort representative of the French population. The relationship between self-reported physical activity and both fatigue and QoL was also investigated. We hypothesized that a greater fatigue and impaired QoL would exist in participants self-reporting CVD symptoms, with the impairments being attenuated in those with greater level of physical activity. METHODS: Using a web-based, custom and adaptive survey, 3008 participants were asked to self-report the presence of common symptoms and risk factors of CVD. Fatigue, QoL, and physical activity were assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue scale, the Chronic Venous Insufficiency Quality of Life Questionnaire, and the Godin-Shepard Leisure-Time Physical Activity Questionnaire, respectively. RESULTS: Thirty-two percent of participants were categorized as having CVD symptoms, whereas 50% were categorized as at risk of CVD. Fatigue was greater in participants with CVD symptoms than non-CVD participants (P < .001), with the score of participants at risk of CVD being intermediate (P ≤ .001). QoL was more impaired in participants with CVD symptoms compared with participants at risk of CVD (P < .001). In participants with CVD symptoms, there were relationships between fatigue and QoL (P < .001) and between physical activity and fatigue (P < .001). Despite the relationship between physical activity and QoL not reaching significance (P = .067), a lower QoL was found in insufficiently active as compared with active (P < .001) and moderately active (P < .001) participants with CVD symptoms. CONCLUSIONS: Participants self-reporting CVD symptoms suffer from greater fatigue and impaired QoL. In this population, a higher level of physical activity is associated with less fatigue and a tendency toward improved QoL.

Detection of skin alterations in mild-to-moderate chronic venous disease using non-invasive techniques.

BACKGROUND: Chronic venous disease (CVD) is secondary to venous hypertension, leading to vascular inflammation and tissue changes. The impact of CVD on skin structure and barrier function is not well characterized. OBJECTIVE: We aimed to assess the characteristics of skin alterations in mild-to-moderate CVD by non-invasive techniques based on a prospective exploratory study. MATERIAL & METHODS: Female subjects (30-75 years) with CVD (Stage C2 to C4, CEAP classification) were eligible. Stage C0-C1 CVD subjects were used as controls. Women with leg surgery or a medical history that could impact the results were excluded. The skin changes on lesional (LS) and non-lesional (NLS) areas were assessed by biometric analysis including skin echography, viscoelasticity evaluation, confocal microscopy and trans epidermal water loss (TEWL) measurements. RESULTS: Thirty-four subjects were enrolled. Based on computation of 26 biometric parameters using Principal Component Analysis, a significant difference between LS and NLS zones, regardless of the CEAP class, was evidenced. C2-C4 subjects presented with dermal thickening suggesting oedema associated with decreased cell density, while no difference in skin viscoelasticity was observed compared to the C0-C1 control group. Epidermal structural modifications were associated with increased TEWL correlating with CVD severity. CONCLUSION: Skin alterations in CVD patients are detectable by non-invasive methods. These findings may help to better assess new therapeutic strategies.

Comparison between bioelectrical impedance spectroscopy measurements and water volume displacement of ankle oedema variations during the course of a day.

OBJECTIVE: The purpose of this study was to find relationships between variations in bioelectrical impedance spectroscopy (BIS) measurements and those obtained by water displacement (WD) and calf (C) and ankle (A) perimetry on legs of patients with venous insufficiency and lower limb oedema, some with positive pitting test (PPT), others with negative pitting test (NPT). APPROACH: Twenty-nine (29) female subjects were clinically examined prior to inclusion in the trial. Measurements were taken once in the morning and then 6 h later, using perimetry, WD, and then BIS; subjects were standing. Leg volume was assessed using two WD volumeters, one 'Tall' (TWD) and one 'Short' (SWD). BIS was performed using a SFB7 impedance meter device (Impedimed®). MAIN RESULTS: Forty-three (43) legs with oedema were included. The results showed that 61% of the TWD variations variance was explained by SWD variations; less than 30% of the TWD variations variance was explained using BIS or perimetry alone, and 45% at best when used in combination. R0, related to extracellular water, was the key BIS parameter. For NPT subpopulation (32 legs), the composite parameter (C2 - A2)/R0 explained more than 60% of the TWD variations variance. For PPT subpopulation (11 legs), small or statistically non-significant variance explanations were found. SIGNIFICANCE: Combination of anthropometric and BIS parameters gave a better forecast of WD results than using only one or other. A novel composite parameter, (C2 - A2)/R0, better predicted TWD changes than other parameters hitherto used in literature, with improved estimates for the NPT subpopulation. Study n°ANSM 2017-A01063-50.

Ambulatory sensor for circumference monitoring of lower limbs.

The continuous monitoring of edema in the lower limbs of the human body is presently not possible as suitable devices are not available. This paper presents the characterization and the testing of a novel ambulatory device dedicated to the monitoring of circumference variations in the lower limb. The sensor, based on an inductive loop integrated into a textile band, is connected to a miniaturized electronic system which wirelessly sends the calculated perimeter value of the leg to a smart mobile device. In-vitro tests have demonstrated that the device enables the measurement of perimeters ranging from 25 cm to 33 cm with an accuracy of 0.3 cm. This result was obtained using a circular loop, which assumes that the shape of the leg remains circular at the location where the loop is positioned. To investigate the influence of the loop shape on the sensor response, three physical models of different shapes (circular, elliptic and triangular) were tested. It was found that self-inductance values of the loop can be predicted in an acceptable way using a theoretical model for the three different shapes. Experimental tests showed that the error in the perimeter value is around 5% of the full scale when changing the geometry from circular to elliptic but can reach 11 % from circular to triangular. The application interface developed for a smartphone is presented, which will enable the ambulatory monitoring of leg edemic swelling during daily activity and facilitate its assessment by the clinician.