Efficacy and safety of a new pneumatic compression device for peripheral arterial disease with intermittent claudication

Phlebologie ◽  
2014 ◽  
Vol 43 (01) ◽  
pp. 5-11 ◽  
Author(s):  
A. Zelikovski ◽  
Z. Loberman ◽  
G. Rauh ◽  
F. X. Breu

SummaryBackground: The primary objective of the study was to demonstrate that Intermittent Pneumatic Compression (IPC) with the new ANGIO PRESS™ IPC device can significantly improve the walking distance, i.e. pain free initial intermittent claudication distance (ICD) and the absolute claudication distance (ACD) in patients with stage II peripheral arterial occlusive disease (PAD) compared to control treatment.Patients and methods: A total of 67 patients were screened and randomized into the study in four clinical centers based in Israel and Germany. Patients were randomized to one of the two study groups: 1. Medication treatment with ASS / Clopidogrel and standardized walking exercise with additional IPC treatment, two times per day for 1.5 hours for three months. 2. Medication treatment and standardized walking exercise alone. The safety and efficacy of the ANGIO PRESS™ device was determined for the treatment of symptoms of PAD Fontaine stage IIb by measuring the pain free walking distance, the absolute walking distance, the ankle-brachial-index (ABI) and the walking pain. Additionally the quality of life (QOL) of each subject was assessed according to the SF-36 questionnaire. Subjects were followed up at six weeks and 3 months.Results: No statistical differences were observed in any of the demographic characteristics and baseline scores. A significant difference was found between the treatment and control group in the ACD and the walking pain scale. Subjects in the treatment group improved their total walking distance in 54 meters, an improvement of 40% compared to their baseline distance. The walking pain improved by 1.89 points in the treatment group. Despite the fact that the difference in the ICD between the study groups were not found significantly different, the mean change from baseline in ICD score at the three month visit in the treatment group of 37 m was found statistically significant (p=0.0002), whereas the mean change of 20.7 m in the control group was not found significantly different. No changes were found between the study groups in the ABI and the QOL. The treatment was easy to tolerate and most patients suffered no side-effects, nor complained of any significant discomfort. Two subjects suffered from SAEs which were determined as not related to the study treatment.Conclusion: The ANGIO PRESS™ is a non-invasive, easy to use, home treatment which is safe and moderately effective for the treatment of intermittent claudication. The ability of subjects to improve their absolute walking distance and reduce the walking pain on the same time may offer a significant value for patients at early stages of PAD who are not indicated for an invasive treatment.

2019 ◽  
Vol 37 (1) ◽  
pp. 45-49
Author(s):  
Talon Maningas ◽  
Lindsay Sturm ◽  
Angela Mangler ◽  
Vanessa K. Pazdernik

Manual lymphatic drainage (MLD) performed by lymphatic massage, in the postoperative period after abdominoplasty with core liposuction, may promote a faster resolution of edema. The purpose of this study was to determine the benefits of MLD by assessing the amount of edema at 6 and 8 weeks after abdominoplasty with core liposuction in patients who did or did not receive MLD for 3 weeks. The study used a prospective, comparative design. A total of 20 women aged 30 to 60 years, who underwent an abdominoplasty and core liposuction, were recruited from 2 clinics. Participants were divided into 2 equal groups based on clinic location. All participants wore a standard compression garment for 8 weeks after surgery. Starting at 6 weeks after surgery, the treatment group was treated by a certified lymphedema specialist twice a week for 3 weeks (6 visits). At 6 and 8 weeks after surgery, the waist circumferences of all participants were measured in 3 locations: at the navel, 3 cm above the navel, and 3 cm below the nave. Data from the 2 groups were compared to determine the change in edema. The mean age of participants was 41.6 years (range = 32-59 years) in the treatment group and 40.8 years (range = 30-59 years) in the control group. The mean (SD) reduction in edema between weeks 6 and 8 in the treatment group was 9.8 cm; 1 participant lost 18.2 cm during that period. The mean (SD) reduction in edema between weeks 6 and 8 in the control group was 6.6 cm; a few participants lost 12.0 cm during that period. No differences in mean reductions were found between groups ( P = .11). No differences were found between groups based on clinic location ( P = .84). Our results suggested that receiving MLD after abdominoplasty and core liposuction reduced edema more than the standard compressive garments, but not by a statistically significant amount. Furthermore, differences in the study groups were not dependent on clinic location.


VASA ◽  
2017 ◽  
Vol 46 (6) ◽  
pp. 462-470 ◽  
Author(s):  
Gerald Hackl ◽  
Andreas Prenner ◽  
Philipp Jud ◽  
Franz Hafner ◽  
Peter Rief ◽  
...  

Abstract. Background: Auricular nerve stimulation has been proven effective in different diseases. We investigated if a conservative therapeutic alternative for claudication in peripheral arterial occlusive disease (PAD) via electroacupuncture of the outer ear can be established. Patients and methods: In this prospective, double-blinded trial an ear acupuncture using an electroacupuncture device was carried out in 40 PAD patients in Fontaine stage IIb. Twenty patients were randomized to the verum group using a fully functional electroacupuncture device, the other 20 patients received a sham device (control group). Per patient, eight cycles (1 cycle = 1 week) of electroacupuncture were performed. The primary endpoint was defined as a significantly more frequent doubling of the absolute walking distance after eight cycles in the verum group compared to controls in a standardized treadmill testing. Secondary endpoints were a significant improvement of the total score of the Walking Impairment Questionnaire (WIQ) as well as improvements in health related quality of life using the Short Form 36 Health Survey (SF-36). Results: There were no differences in baseline characteristics between the two groups. The initial walking distance significantly increased in both groups (verum group [means]: 182 [95 % CI 128–236] meters to 345 [95 % CI 227–463] meters [+ 90 %], p < 0.01; control group [means]: 159 [95 % CI 109–210] meters to 268 [95 % CI 182–366] meters [+ 69 %], p = 0.01). Twelve patients (60 %) in the verum group and five patients (25 %) in controls reached the primary endpoint of doubling walking distance (p = 0.05). The total score of WIQ significantly improved in the verum group (+ 22 %, p = 0.01) but not in controls (+ 8 %, p = 0.56). SF-36 showed significantly improvements in six out of eight categories in the verum group and only in one of eight in controls. Conclusions: Electroacupuncture of the outer ear seems to be an easy-to-use therapeutic option in an age of increasingly invasive and mechanically complex treatments for PAD patients.


2019 ◽  
Vol 15 (02) ◽  
pp. 14-17
Author(s):  
K K Hadiya ◽  
A J Dhami ◽  
D V Chaudhari ◽  
P M Lunagariya

This study was initiated on 24 prepubertal Holstein x Kankrej crossbred heifers of nearly identical age (7-9 months) and body weight (130-140 kg) at University farm to evaluate the effect of high plane of nutrition on blood biochemical and minerals profile and the age at puberty. Twelve heifers were managed under routine farm feeding (control) and the rest 12 under ideal optimum feeding regime (treatment) that included extra 1 kg concentrate, 30 g min mix and ad-lib dry fodder. The body weight and ovarian ultrasonography together with blood sampling was carried out at monthly interval from 10 to 18 months of age to study the ovarian dynamics and blood biochemical changes. High plane of nutrition to growing heifers was beneficial in reducing the age of onset of puberty (by 2-3 months) compared to routine farm fed group. The mean plasma total protein and cholesterol concentrations showed a rising trend with significant variations from 10 to 16 months of age, where it got mostly stabilized indicating adult profile. The activity of enzymes GOT and GPT also rose gradually and significantly from 10 months till 14-15 months of age, and thereafter it remained more or less static till 18 months of age. The levels of both these enzymes were higher, with lower protein and cholesterol, in control than the treatment group from 15-16 months of age onwards. The mean plasma levels of both calcium and phosphorus increased gradually and significantly with advancing age till 16-17 months of age, with little higher values in supplemented than a control group. The plasma levels of zinc, iron, copper, and cobalt also showed rising trend with significant differences between 10th and 12th-14th months of age, and from 15th to 18th months of age the levels were statistically the same in all the groups with slightly higher values in the treatment group.


2021 ◽  
Vol 9 (2) ◽  
pp. 198-207
Author(s):  
Habibah Abidin ◽  
Apoina Kartini ◽  
Ani Margawati

Background: A Kader refers to a Village Health Worker (VHW), a volunteer, which becomes one of the sources of community reference. Commonly, they sustain a mother's knowledge regarding adequate complementary feeding. However, there are still some VHW who have not possessed a health education background nor been able to be independent.Objectives: This study aimed to analyze the impact of collaborative models on VHW's competence as in knowledge, self-efficacy, attitudes, and counseling skill on the topic of complementary feeding.Materials and Methods: The design of this research is a quasi-experiment control group pretest-postest, with the retrieval of subjects using purposive sampling. Subjects were selected based on the location of the posyandu. The population in this research was VHWs in the Lembang district were 40 VHWs in each group. The treatment group was given training intervention for 1 month with a collaborative model, combining several methods into a series. The main topic was counseling and complementary feeding. The control group was given booklets and leaflets. VHW's competence was measured using questionnaires. This research was conducted in January-April 2020.Results: Statistical test results before the treatment of both groups showed no difference (p>0,05) in each variable. Two months after the intervention, there were significant differensces in the mean score of knowledge (p=0,001), attitude (p=0,001), and VHWs self-efficacy (p=0,000) in both groups. VHW counseling skills (p=0,149) until the first month there was not a significant difference. Unexpectedly, in the second month, the VHW counseling skills could not be observed due to the global COVID-19 pandemic. The mean score of each group increased significantly, but the score of the treatment group was higher than the control group.Conclusions: A collaborative model is effective when compared to only providing booklets and leaflets in increasing VHW's knowledge, attitudes, and self-efficacy but not effective yet for VHW counseling skills.


PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0250311
Author(s):  
Aonan Zhang ◽  
Lin Zhu ◽  
Zhenghao Shi ◽  
Tianying Liu ◽  
Lanlan Han ◽  
...  

The soybean aphid Aphis glycines Matsumura (Hemiptera: Aphididae) is a primary pest of soybeans and poses a serious threat to soybean production. Our studies were conducted to understand the effects of different concentrations of insecticides (imidacloprid and thiamethoxam) on A. glycines and provided critical information for its effective management. Here, we found that the mean generation time and adult and total pre-nymphiposition periods of the LC50 imidacloprid- and thiamethoxam-treatment groups were significantly longer than those of the control group, although the adult pre-nymphiposition period in LC30 imidacloprid and thiamethoxam treatment groups was significantly shorter than that of the control group. Additionally, the mean fecundity per female adult, net reproductive rate, intrinsic rate of increase, and finite rate of increase of the LC30 imidacloprid-treatment group were significantly lower than those of the control group and higher than those of the LC50 imidacloprid-treatment group (P < 0.05). Moreover, both insecticides exerted stress effects on A. glycines, and specimens treated with the two insecticides at the LC50 showed a significant decrease in their growth rates relative to those treated with the insecticides at LC30. These results provide a reference for exploring the effects of imidacloprid and thiamethoxam on A. glycines population dynamics in the field and offer insight to agricultural producers on the potential of low-lethal concentrations of insecticides to stimulate insect reproduction during insecticide application.


2021 ◽  
Vol 4 (1) ◽  
pp. 27
Author(s):  
Muhammad Aulia U H ◽  
Iswinarno Doso Saputro ◽  
Magda Rosalina Hutagalung

Background: The incidence of burns in Indonesia progressively increases with the increase in its population and industries. From January to September 2000, 158 patients were treated in the burn unit of Dr Soetomo Hospital with a mortality rate reaching 5,8%. Burns have a direct effect in causing both local and systemic changes in the body, not occurring in other injuries. In severe burns, a hypermetabolic state can occur, which increases cardiac workload and causes muscle atrophy and other morbidities. The purpose of this study is to examine the effect of propranolol on the hypermetabolic state in severely burned patients by measuring various clinical & laboratory parameters.Methods : This is an experimental study using pre and post test control group design with the objective of assessing the treatment outcome with oral propranolol given in 15 consecutive days for burn patients involving 25%- 60% TBSA. Measurements were taken three times, on day 0, 7 and 14.Results : Obtained 16 samples divided into 2 groups. In the treatment group, there was a significant decrease in CRP levels on days 0, 7 and 14 (p <0.05). The Mid Arm Circumference variable did not obtain a significant decreasing on days 0, 7 and 14. The albumin level studied showed a significant decreasing on day 0 & 7 days with a value of p = 0.045. From the comparison between the two groups, there were significant differences in CRP levels on days 0 & 14, with the mean value of the treatment group -5.12 + 2.88 and the mean value of the control group 2.86 + 7.37, and the value of p = 0.019.Conclusions: This study successfully proved that the administration of propranolol can overcome the effects of hypermetabolism which is characterized by decreasing in CRP levels.


2019 ◽  
Vol 3 (5) ◽  
pp. 238-243
Author(s):  
I Ketut Swiryajaya ◽  
Iswari Pauzi

As a result of IDD is the occurrence of impaired child growth makes researchers interested in conducting research on "Provision of iodized salt, food counseling about the source of iodine and goitrogenic substances with urinary iodine excretion status in elementary school children". Research on IDD is often carried out in primary school-age children, aged 6-12 years because of their vulnerability to iodine deficiency. The purpose of this study was to determine the effect of iodized salt interventions and counseling patterns of iodized and goitrogenic food consumption patterns on levels of urinary yodiun excretion in families with elementary school children. Research methods: The design of this study included quasi-experimental using a specific design that is "pre and post test control group design". The study population was elementary school children with a sample size of 30 children aged 9 -12 years in each group. Data collected included the consumption of nutrients by the 24-hour recall method, the results of urine iodine examination by the spectrophotometric method. The collected data is then analyzed with an independent sample T test. The results showed there were differences in urinary yodiun excretion levels in the two groups (treatment and control), while the mean in the treatment group before intervention was 106.97 ug / L and after the intervention was 43.19 ug / L. Whereas in the control group, the level of urinary yodiun excretion before intervention was 117.30 μg / L and after the intervention was 243.19 μg / L. The mean of respondents who consumed goitrogenic sources in the treatment group before the intervention (Yes = 63%, No = 37%), after the intervention (Yes = 23%, No = 77%). Whereas in the Control group before the intervention (Yes = 56%, No = 73%), after the intervention (Yes = 23%, No = 77%). The average amount of protein consumption before treatment was 47.91 µg/L ± 6.54 and 50.15 µg/L ± 12.52 after treatment. For consumption, an increase with a mean before treatment was 89.88 µg/L ± 38.45 and after treatment was 113 µg/L ± 26. The results of the independent sample t-test showed that in the treatment group there was no significant difference between after and before the intervention (p = 0.058). Whereas in the control group there were significant differences between before and after the intervention (p = 0.002). It can be concluded that there are many factors that need to be controlled in the provision of interventions, especially the use, type of salt and goitronic as well as the method of examination of iodine analysis in urine. Keywords: iodized salt; iodine food sources; goitrogenic; urinary iodine excretion


2013 ◽  
Vol 2013 ◽  
pp. 1-8
Author(s):  
Cesar Varela ◽  
Joaquin de Haro ◽  
Silvia Bleda ◽  
Leticia Esparza ◽  
Ignacio Lopez de Maturana ◽  
...  

Our aim is to investigate a possible association of circulating anti-beta2-glycoprotein I antibodies (ABGPI) with the endothelial dysfunction, nitric oxide bioactivity dysregulation, and the inflammatory status that surrounds peripheral arterial disease. We carried out an observational translational study, including 50 male patients with intermittent claudication and a healthy control group of 10 male subjects, age and sex matched with the cases. Flow-mediated arterial dilatation (FMAD) was assessed as a surrogate of endothelial dysfunction, and C-reactive protein (hsCRP) was determined as a marker of inflammation. Nitrite plasma levels were measured by colorimetric analysis. Circulating ABGPI titer was detected with indirect immunofluorescence. Titers <1 : 10 represented the reference range and the lower detection limit of the test. Circulating ABGPI titer ≥1 : 10 was detected in 21 (42%) patients and in none of the control subjects (P<0.01). Patients with ABGPI titer ≥1 : 10 had a lower FMAD (P=0.01). The CRP levels were higher in patients with ABGPI titer ≥1 : 10 (P=0.04). The nitrite plasma levels were higher in patients with ABGPI titer ≥1 : 10 (P<0.01). These data suggest that these circulating ABGPI may collaborate in the development of atherosclerosis; however, further prospective studies are required to establish a causal relationship.


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030002 ◽  
Author(s):  
Lindsay Bearne ◽  
Melissa Galea Holmes ◽  
Julie Bieles ◽  
Saskia Eddy ◽  
Graham Fisher ◽  
...  

IntroductionWalking exercise is a recommended but underused treatment for intermittent claudication caused by peripheral arterial disease (PAD). Addressing the factors that influence walking exercise may increase patient uptake of and adherence to recommended walking. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a physiotherapist-led behavioural change intervention on walking ability in adults with intermittent claudication (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in comparison with usual care.Methods and analysisThe MOSAIC trial is a two-arm, parallel-group, single-blind RCT. 192 adults will be recruited from six National Health Service Hospital Trusts. Inclusion criteria are: aged ≥50 years, PAD (Ankle Brachial Pressure Index ≤0.90, radiographic evidence or clinician report) and intermittent claudication (San Diego Claudication Questionnaire), being able and willing to participate and provide informed consent. The primary outcome is walking ability (6 min walking distance) at 3 months. Outcomes will be obtained at baseline, 3 and 6 months by an assessor blind to group allocation. Participants will be individually randomised (n=96/group, stratified by centre) to receive either MOSAIC or usual care by an independent randomisation service. Estimates of treatment effects will use an intention-to-treat framework implemented using multiple regression adjusted for baseline values and centre.Ethics and disseminationThis trial has full ethical approval (London—Bloomsbury Research Ethics Committee (17/LO/0568)). It will be disseminated via patient forums, peer-reviewed publications and conference presentations.Trial registration numberISRCTN14501418


2008 ◽  
Vol 78 (2) ◽  
pp. 324-331 ◽  
Author(s):  
Katri Keski-Nisula ◽  
Leo Keski-Nisula ◽  
Hannu Salo ◽  
Kati Voipio ◽  
Juha Varrela

Abstract Objective: To evaluate skeletal and dentoalveolar changes induced by the eruption guidance appliance in the early mixed dentition. Materials and Methods: Pre- and posttreatment cephalometric radiographs of 115 consecutively treated children, 62 boys and 53 girls, were compared with those obtained from a control group of 104 children, 52 boys and 52 girls. Pretreatment radiographs were taken at the deciduous-mixed dentition interphase (T1) and after full eruption of all permanent incisors and first molars (T2). The mean age of the children in both groups was 5.1 years at T1 and 8.4 years at T2. Results: A significant difference between the groups at T2 was found in the mandibular length, midfacial length, and maxillomandibular differential. The increase in mandibular length was 11.1 mm in the treatment group and 7.2 mm in the control group. No differences were found in measurements of maxillary position or size. There was a significant shift toward a Class I relationship in the treatment group. Labial tipping and linear protrusion of the mandibular incisors was evident in the treatment group at T2. There was no effect on the inclination or position of the maxillary incisors. Conclusions: Occlusal correction was achieved mainly through changes in the dentoalveolar region of the mandible. In addition, the appliance enhanced condylar growth resulting in a clinically significant increase in mandibular length. No effect was observed on maxillary position, maxillary size, inclination or protrusion of the maxillary incisors, or facial height.


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