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Clinical study on VenoTrain angioflow Effective and secure

Issue 03/2018

Compression therapy can in some cases be used to treat both vein problems and early-stage peripheral arterial disease. A clinical study on the VenoTrain angioflow compression stocking currently being conducted at the Vein Center at Ruhr University Bochum, Germany,  offers some convincing evidence of this.

Prof. Dr. med. Markus Stücker greets his patient Helene Kerber1 with a warm handshake after she arrives at the clinic in the Vein Center in Bochum. “Ms. Kerber is one of the typical patients who could benefit from the VenoTrain angioflow compression stocking,” says Stücker, Senior Physician at the Vein Center of the Dermatology and Vascular Surgery clinics at Ruhr University Bochum. Kerber, 83, suffers from chronic venous insufficiency (CVI) with CEAP classification C3, and peripheral arterial disease (PAD) in Fontaine stage IIb. “The combination of CVI and PAD is really not that uncommon at all , especially in older people,” Stücker explains. According to the Bonn Vein Study, one out of every six men and one out of five women suffer from chronic venous insufficiency2. In addition, it is estimated that around 20 percent of all people over 60 (regardless of gender) suffer from PAD. Although men and women are affected more or less equally here, more women than men come to see Prof. Stücker in the Vein Center. “CVI symptoms usually don’t show in men until a relatively late stage of the condition,” Stücker explains, “Women who have vein problems experience swelling much more quickly than men do – it’s basically a gender-specific difference. Men usually don’t go to a doctor until CVI reaches a severe stage that often leads to skin complications as well.”

The courage to prescribe compression therapy

Important parameter: the systolic arterial pressure in the big toe is measured.
Important parameter: the systolic arterial pressure in the big toe is measured.

There is still uncertainty among medical professionals regarding the proper approach for treating a mixed condition consisting of chronic venous insufficiency and peripheral arterial disease. “This is also due to the fact that PAD is listed in the contraindication catalog as a contraindication under compression therapy,” Stücker explains. “While the catalog does explicitly state that it’s a ‘relative’ contraindica-tion, the listing nevertheless often leads many physicians to forgo compression therapy, and that’s definitely not justified.” What Stücker means is that because of this hesitancy, many patients are denied an effective treatment. “After all , a relative contraindication really only means proceed with care in this combination of illnesses, but physicians often don’t understand that ,” says Stücker. “Basically, colleagues could be a bit more courageous here.”
Once a combined condition has been diagnosed, physicians need to determine how pronounced the PAD is. They need to ask questions such as: What is the ankle-brachial index value? What is the absolute arterial pressure at the ankle? How severe are the clinical symptoms? Is the patient’s walking distance only slightly limited or is it heavily restricted? How quickly did the symptoms develop? “The clinical examination and diagnosis often indicate that compression makes sense,” says Stücker.
Up until recently, the compression therapy was usually performed with a Ccl 1 stocking. “However, with VenoTrain angioflow, we now have a very good new treatment option,” Stücker explains. Thanks to its combination of low resting pressure and high working pressure, the compression stocking can also be used to treat chronic venous insufficiency in patients with early-stage PAD. More specifically, the stocking can be used on patients with an ankle-brachial index (ABI) of 0.5-0.9 and arterial pressure of at least 60 mmHg at the ankle.

Clinical study confirms safety

Prof. Stücker observed a significant reduction of venous symptoms with VenoTrain angioflow.
Prof. Stücker observed a significant reduction of venous symptoms with VenoTrain angioflow.

“We decided to conduct a clinical study to examine in greater detail whether the stocking can provide safe and effective treatment for CVI patients with the relative contraindication of early-stage PAD,” Stücker explains. Patients with stage C3-C5 CVI and slight PAD (ABI < 0.9 and > 0.5 and arterial pressure at the ankle of > 60 mmHg) were recruited from the Vein Center’s outpatient clinic.
The study participants wore VenoTrain angioflow on the affected leg for at least six hours every day over a period of two weeks. Data from 30 test patients has now been analyzed. “The most important finding was that wearing VenoTrain angioflow did not cause the systolic arterial pressure in the big toe to decrease to any relevant extent ,” Stücker reports. “In fact , we even observed an increase in peripheral arterial perfusion throughout the course of the study. In the case of patients with arterial disease in particular, it is crucial to ensure that the compression garment does not lead to a further reduction of arterial pressure. The measured values show that there was no danger to the selected patient clientele at any time. In other words, VenoTrain angioflow is safe – but that’s not all , since it also does what it’s supposed to do.”
The study team in Bochum was thus able to show that the use of VenoTrain angioflow led to a significant edema reduction on the lower leg. “Wearing the stocking tended to lead to an edema reduction,” says Stücker. “The average volume reduction on the lower leg that was documented using the Bodytronic 600 measurement system was nearly 100 milliliters, which is similar to the result achieved in other studies with compression stockings.”

Good wearing comfort and easy to put on

Measuring for stockings with Bodytronic 600.
Measuring for stockings with Bodytronic 600.

“If you want to treat CVI accompanied with early-stage PAD safely and effectively, the compression stocking must have a low resting pressure and a high working pressure,” Stücker explains. “If this condition is met , the desired massage effect can be achieved when the patient wears the stocking, and the venous pump function, which effectively decongests the leg, will also improve.” A high working pressure also increases the stiffness of the compression knit. “Along with the therapeutic massage effect , this offers an additional benefit in that the stocking doesn’t constrict that easily,” says Stücker. “Although one might assume that the higher stiffness makes it more difficult to put on the stocking, this is definitely not the case.” Despite the relatively short-stretch material , the test subjects, or their family members who helped them, had no problems putting on or taking off the stocking. This was also confirmed by student assistants who watched when the medical compression stocking was put on. The reason this is easy to put on and take off has to do with the fact that VenoTrain angioflow is “knit to contour.” This, in turn, is made possible by digital measurement of the leg with Bodytronic 600. The large number of measuring points are incorporated into the knitting program, which means the finished stocking is precisely aligned with the leg contour, fits like a second skin, and is easy to put on. The participants in the study reported that VenoTrain angioflow was very comfortable to wear. “In this regard it’s interesting to note that many of the patients had already worn compression stockings before, which makes their assessment of wearing comfort even more significant ,” says Stücker, who also believes that VenoTrain angioflow has great potential: “The patient clientele is there, and when you consider the low resting pressure, and especially the low pressure in the foot area, you see that ­VenoTrain angioflow is the safe way to go with early-stage PAD as well. Nevertheless, it still makes sense to perform clinical follow-up examinations in the case of combined CVI/PAD, and the ankle-brachial index should be measured again as well.”
Helene Kerber has now completed her preliminary examinations and the initial assumption has been confirmed, so Prof. Stücker starts writing out a VenoTrain angioflow prescription for his 83-year-old patient.

Effective contoured knitted fabric

Precise measuring with Bodytronic 600 and 610

VenoTrain angioflow is a customized stocking that must fit like a second skin on account of its special properties. For this reason, more measuring points are needed for this stocking than when fitting a conventional compression stocking. In order to ensure a perfect fit , measurements for VenoTrain angioflow should be taken with the Bodytronic 600 or 610 digital measurement systems, which automatically determine several hundred measuring points along the leg and create precise 3D images. Using these measurements as a basis, the VenoTrain angioflow can be knitted to perfectly match the contours of the leg. If no digital measurement system is available, additional measuring points will need to be used for measurements made with tape measures.

1 Name has been changed.
2 Rabe E., Pannier-Fischer F., Bromen K., Schuldt K., Stang A., Poncar Ch., Wittenhorst M., Bock E., Weber S., Jöckel KH. Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie. Epidemiologische Untersuchung zur Frage der Häufigkeit und Ausprägung von chronischen Venenkrankheiten in der städtischen und ländlichen Wohnbevölkerung. Phlebologie 2003; 32: 1–14.

Images: Michael Bause (4), Bauerfeind


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