The anthropometric characteristics in the two groups were not significantly different.

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1 Studio prospettico, randomizzato monocentrico per il trattamento sintomatico dell insufficienza venosa cronica degli arti inferiori in pazienti trattati con calze preventive con filato SpikEnergy rispetto a pazienti trattati con calze preventive standard (Studio SEVI). A prospective, randomized, monocentric study on chronic venous insufficiency s symptoms treatment with compressive pantyhose with SpikEnergy yarn versus compressive standard stocking: the SEVI Study. INTRODUCTION Chronic venous insufficiency is a common disease that affects a huge part of the population (10-40% of adults), in particularly in female subgroup. Limb compression using graduate compressive socks and pantyhose is widely recommended as cardinal treatment of the symptoms of chronic venous insufficiency in cases of low-moderate insufficiency that are not candidate to surgery. SpikEnergy is a yarn made of copper, silicon and zinc that creates a low electromagnetic 300 microampere 4/10 nanotesla camp that as previously been tested in orthopaedic tutors with good results in terms of pain relieve and tolerability. The aim of this study is to evaluate the efficacy, easy of use and the results on venous insufficiency obtained whit a system consisting in 18 mmhg compressive pantyhose that contain SpikEnergy yarn when compared to common 18 mmhg compressive pantyhose that are usually prescribed in these kind of patients. METHODS The study was a prospective, randomized clinical trial performed in one single centre specialized in venous insufficiency evaluation and treatment. The study included 40 consecutive female patients who underwent clinical evaluation for venous insufficiency and that presented a superficial venous insufficiency classified as low-moderate, in absence of deep or superficial venous thrombosis or phlebostatic ulcers. Within 7 day from the screening visit, all the patients had to do a pregnancy test except for those already in menopause, and only those with negative test were enrolled.

2 At the first enrolment visit each patient was submitted to a complete physical examination that included the evaluation of oedema with the registration of ankle, calf and thigh circumference and the evaluation of venous insufficiency clinical signs such as varicose veins or the presence of teleangectasias. Anamnesis was performed, to evaluate inclusion and exclusion criteria, other comorbidities, the presence of allergies and the concomitant use of other medicines. Each patient was then submitted to ultrasonographic evaluation and to a series of questionnaires about the symptoms, using a numerical analogue scale (varying from 0 to 10) to evaluate pain, itch, burning and to assess the alteration of the quality of life concerning the venous insufficiency. Then an automatic computed randomization was performed; 20 patients received common pantyhose and were denominated Standard Group (ST), while the other 20 received pantyhose with SpikEnergy yarn and were denominated SpikEnergy Group (SP). The SpikEnergy pantyhoses were create cappello (Prof. Dotti?) su come hanno creato la calze, il campo elettromagnetico, I macchinari per la corretta calibratura di entrambi I modelli di calze. Both the groups were instructed to wear the system for at least 8 hours per day and to immediately contact the investigators in case of adverse events. At the 1 month (± 7 days) follow-up visit, each patient was submitted to the physical examination and to the symptoms questionnaires; moreover, a questionnaires regarding the tolerability, mobility and general satisfaction of the patient about her stocking system was compiled (possible assessments were excellent, good, satisfactory, poor or insufficient). At the 6 months (± 14 days) follow-up visits, each patient was submitted to the same kind of visit as the 1 month follow-up and was also submitted to ultrasonographic evaluation of the venous insufficiency level. Study enrolment started on May 12, 2011, the enrolment period was of 6 month, and the study ended on may 14, Inclusion criteria were: -age > 18 years -informed consent -patient C1-3, Ep,s, As,p, Pr, according to CEAP classification -patients able to wear compressive stocking system

3 Exclusion criteria were: -pregnancy -other classes of CEAP classification -use of phlebotonic drugs -limb arteriopathy -high risk of deep venous thrombosis -thrombophilic patients -hyperhomocysteinemia -allergy to the device s materials -neuropathy -cutaneous infection Primary end points were the reduction of oedema and the reduction of symptoms, in particularly pain, itch, burning and the improvement of quality of life, assessed with numeric analogue scales (NAS), and the eventual improvement of venous insufficiency evaluate with duplex scan. Secondary end points were the tolerability of the stocking system, the easy to use and mobility granted by the system and the general satisfaction of the patient. Statistical analysis was performed and data were presented as a distribution of continuous variables (mean, median, lower and higher value and standard deviation) and as frequency of categorical variables (absolute value and percentage); 95% confidence intervals were calculated. Frequencies were analysed with χ 2 testing or with exact Fisher s test, with t-test was used to evaluate normally distributed linear variables, or the Wilcoxon test. A p value < 0.05 has been considered statistically significant, and all the tests had two tails. RESULTS The study included an homogenous cohort of 40 female patients whose CEAP classification was C2,3, Ep, As, Pr. Three patients (7,5%) matched exclusion criteria of previous venous surgery but only for one leg while the other leg matched inclusion criteria, so it was considered a minor violation and the patients were included in the study.

4 The anthropometric characteristics in the two groups were not significantly different. Spikenergy (SP) Standard (ST) All Age (years) Mean Median 44.51( ) ( ) ( ) Height (cm) Mean Median ( ) ( ) ( ) Weight (kg) Mean Median 64 (48-88) 58 (45-104) 62 (45-104) BMI Mean Median ( ) ( ) ( ) As in general population, the percentage of patients with a family history of cardiovascular disease was high (30/40 patients, 75%), while other comorbidities were well distributed. Spikenergy (SP) Standard (ST) All Family History OF CVD 14 (70%) 16 (80%) 30 (75%) Smoking 2 (10%) 7 (35%) 9 (22.5%) Obesity 5 (25%) 6 (30%) 11 (27.5%) Dyslipidemia 5 (25%) 3 (15%) 8 (20%) Hypertension 1 (5%) 3 (15%) 4 (10%) CAD COPD Allergies 9 (45%) 8 (40%) 17 (42.5%) The pantyhose was correctly worn from all the patients during the entire study period, none of the patient stopped the study and all the patients regularly presented at the 1 month and 6 months follow-up visit. None adverse event was observed during the study. Thirty-eight patients (95%), presented at baseline visit with ankle oedema, so ranging C3 in CEAP classification. Comparing circumferences changes between baseline and 1 month follow-up, we observed a mean 0,20 cm reduction of ankle circumference in the SP group as well as in the ST group (t value 0, p ), a mean 0,23 cm reduction of calf circumference in the SP group versus an absence of variation in the ST group (t value , p ) and a

5 mean 0,33 cm reduction of thigh circumference in the SP group versus a mean 0,10 cm increase in the ST group (t value , p ). Comparing circumferences changes between baseline and 6 months follow-up, we observed a mean 0,40 cm reduction of ankle circumference in the SP group and a mean 0,30 cm reduction in the ST group (t value , p ), a mean 0,73 cm reduction of calf circumference in the SP group versus a mean 0,18 cm increase in the ST group (t value , p ) and a mean 0,63 cm reduction of thigh circumference in the SP group versus a mean 0,55 cm reduction in the ST group (t value , p ). Comparing symptoms, at 1 month pain reduced from a mean 3.40 to a mean 3.30 value in SP group and from a mean 5.2 to a mean 3.25 value in the ST group, itch increased from

6 a mean 1.70 to a mean 4.35 value in the SP group and reduced from a mean 2.05 to a mean 1.95 value in the ST group, burning reduced from a mean 2.40 to a mean 2.30 value in the SP group while it reduced from a mean 3.20 to a mean 1.35 mean value in the ST group. Concerning the assessment of quality of life improvements, we observed an increase from a mean 7.55 to a mean 7.75 value in the SP group and an increase form a mean 6.60 to a mean 8.40 value in the ST group. Comparing baseline and 6 month results, pain ad a mean 0.40 reduction in the SP group versus a mean 1.30 increase in the ST group (t value , p ), itch had a mean increase of 1.80 in the SP group versus a mean reduction of 0.05 in the ST group (t value 1.950, p ), burning had a mean 0.35 increase in the SP group and had a mean 1.05 reduction in the ST group (t value 1.332, p ), while quality of life had a mean 0.15 increase in the SP group versus a mean 1.55 increase in the ST group (t value , p ). Analyzing duplex scan findings at baseline, we observed that none of the patient presented with deep venous thrombosis, that was also an exclusion criteria; in most of the cases the venous insufficiency was due to saphenous-femoral ostium or internal

7 saphenous vein incompetence, only in 4 legs we observed saphenous-popliteal and external saphenous vein incompetence. At 6 month follow-up, in the SP group we observed incompetence worsening only in 1 case (only in one leg), passing from a normal continence to mild incompetence of the saphenous-femorale ostium; instead we observed worsening in 4 cases in the standard group: 1 passing from a normal continence to mild incompetence of the saphenousfemorale ostium (only in one leg), 1 passing from normal continence to mild incompetence of the internal saphenous vein (only in one leg), 1 passing from normal continence to mild incompetence of the saphenous-popliteal ostium (only in one leg) and 1 passing from from normal continence to mild incompetence of the external saphenous vein (only in one leg). None improvement in the ultrasonographic findings was observed in both the two groups. Comparing the tolerability, mobility granted by the device and the general satisfaction, the tolerability in the SP group was considered insufficient/poor in 4 cases, satisfactory in 9 cases and good/excellent in 7 cases at 1 month, while in the ST group it was assessed insufficient/poor in 0 case, satisfactory in 2 cases and good/excellent in 18 cases (p ). At 6 month the tolerability in the SP group was considered insufficient/poor in 4 cases, satisfactory in 10 cases and good/excellent in 6 cases, while in the ST group it was assessed insufficient/poor in 0 cases, satisfactory in 3 cases and good/excellent in 17 cases (p ). The mobility granted by the stocking in the SP group was considered insufficient/poor in 1 case, satisfactory in 7 cases and good/excellent in 12 cases at 1 month, while in the ST group it was assessed insufficient/poor in 1 case, satisfactory in 3 cases and good/excellent in 16 cases (p ). At 6 month the mobility in the SP group was considered insufficient/poor in 2 cases, satisfactory in 6 cases and good/excellent in 12 cases, while in the ST group it was assessed insufficient/poor in 1 case, satisfactory in 4 cases and good/excellent in 15 cases (p ). The general satisfaction in the SP group was considered insufficient/poor in 2 cases, satisfactory in 9 cases and good/excellent in 9 cases at 1 month, while in the ST group it was assessed insufficient/poor in 1 case, satisfactory in 1 case and good/excellent in 18 cases (p ). At 6 month the general satisfaction in the SP group was considered insufficient/poor in 3 cases, satisfactory in 8 cases and good/excellent in 9 cases, while in the ST group it was assessed insufficient/poor in 2 case, satisfactory in 3 cases and good/excellent in 15 cases (p ).

8 6 As collateral results, interviewing the patients we observed that those of SP group noticed an improvement in skin aspect and a slight reduction in cellulitis, suggesting a potential role of the electromagnetic camp on this aspect, that could be well investigated in the future. CONCLUSIONS The compressive pantyhose with SpikEnergy yarn seems to be safe; no adverse event was observed during the study not even in those that presented allergy to metals. Analyzing result, we observed a significant reduction of circumference at calf level in the SP group, in the other cases the differences were not statistically significant. Concerning on symptoms, a statistically significant reduction of pain in SP group was observed; however, a significant increase in itch was observed, and in some cases it was

9 evident that the itch was more due to the electromagnetic camp than to venous insufficiency (it disappeared at socks removal). Only slight and not statistically significant differences were observed in ultrasonographic findings, and is important to stress that none of the patient improved during the study, because obviously elastic compression treats the symptoms but can not improve venous valvular incompetence. The most significant information that emerges from the study is about the tolerability and the general satisfaction of the patient, that are significantly poorer in the SP group. Obviously the study is only on a small group of patients; future studies on larger group, eventually groups including also patient with phlebostatic ulcers or venous thrombosis could better understand the role of electromagnetic camp in venous insufficiency; probably it could be useful to test devices with a lower electromagnetic camp that can be more comfortable for the patients.

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