Adjustable Velcro® Compression Devices are More Effective than Inelastic Bandages in Reducing Venous Edema in the Initial Treatment Phase: A Randomized Controlled Trial

Abstract

The objective of this study was to compare the efficacy and comfort of inelastic bandages (IBs) and adjustable Velcro(®) compression devices (AVCDs) in reducing venous leg edema in the initial treatment phase.
Forty legs from 36 patients with untreated venous edema (C3EpsAsdPr) were randomized to two groups. Patients in the first group received IBs (n = 20) and those in the second AVCDs (n = 20). Both compression devices were left on the leg day and night, and were renewed after 1 day. Patients in the AVCD group were asked to re-adjust the device as needed when it felt loose. Leg volume was calculated using the truncated cone formula at baseline (T0), after 1 day (T1) and after 7 days (T7). The interface pressure of the two compression devices was measured by an air filled probe, and the static stiffness index calculated after applying compression at T0 and T1, and just before removal of compression on T1 and T7. Patient comfort with regard to the two compression systems was assessed by grading signs and symptoms using a visual analog scale.
At T1, the median percent volume reduction was 13% for the IB group versus 19% for the AVCD group; at T7 it was 19% versus 26%, respectively (p < .001). The pressure of the IBs was significantly higher compared with the AVCDs at T0 (63 vs. 43 mmHg) but dropped by > 50% over time, while it remained unchanged with AVCDs owing to the periodic readjustment by the patient. Comfort was reported to be similar with the two compression devices.
Re-adjustable AVCDs with a resting pressure of around 40 mmHg are more effective in reducing chronic venous edema than IBs with a resting pressure of around 60 mmHg. AVCDs are effective and well tolerated, not only during maintenance therapy, but also in the initial decongestive treatment phase of patients with venous leg edema.
Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Full text

Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic
Bandages in Reducing Venous Edema in the Initial Treatment Phase: A
Randomized Controlled Trial
G. Mosti
a,*
, A. Cavezzi
b
, H. Partsch
c
, S. Urso
d
, F. Campana
e
a
Clinica MD Barbantini, Via del Calcio n.2, 55100 Lucca, Italy
b
Eurocenter Venalinfa, San Benedetto del Tronto, Italy
c
Medical University Vienna, Vienna, Austria
d
Ospedale Privato Prof. Nobili, Bologna, Italy
e
Clinica Privata Villa Igea, Forlì, Italy
WHAT THIS PAPER ADDS
In routine clinical practice edema is treated by means of inelastic bandages exerting a strong pressure but these
require specialized personnel to be applied. Adjustable Velcro
Ò
compression devices (AVCDs), or elastic
stockings, are used only after the so called initial decongestive phase, in order to maintain the results and
prevent the recurrence of the edema. This study shows that AVCDs can be more effective than inelastic ban-
dages in exerting a very strong pressure in the initial treatment phase and are at least equally well tolerated.This
study is also relevant from a practical point of view as it could change the traditional treatment of edema. The
opportunity to use AVCDs in the initial decongestive phase may allow self-application and self-treatment,
significantly reducing the cost of treatment with regard to materials and specialized personnel.
Objective/Background: The objective of this study was to compare the efficacy and comfort of inelastic bandages
(IBs) and adjustable Velcro
Ò
compression devices (AVCDs) in reducing venous leg edema in the initial treatment
phase.
Methods: Forty legs from 36 patients with untreated venous edema (C3EpsAsdPr) were randomized to two
groups. Patients in the first group received IBs (n¼20) and those in the second AVCDs (n¼20). Both
compression devices were left on the leg day and night, and were renewed after 1 day. Patients in the AVCD
group were asked to re-adjust the device as needed when it felt loose. Leg volume was calculated using the
truncated cone formula at baseline (T0), after 1 day (T1) and after 7 days (T7). The interface pressure of the two
compression devices was measured by an air filled probe, and the static stiffness index calculated after applying
compression at T0 and T1, and just before removal of compression on T1 and T7. Patient comfort with regard to
the two compression systems was assessed by grading signs and symptoms using a visual analog scale.
Results: At T1, the median percent volume reduction was 13% for the IB group versus 19% for the AVCD group;
at T7 it was 19% versus 26%, respectively (p<.001). The pressure of the IBs was significantly higher compared
with the AVCDs at T0 (63 vs. 43 mmHg) but dropped by >50% over time, while it remained unchanged with
AVCDs owing to the periodic readjustment by the patient. Comfort was reported to be similar with the two
compression devices.
Conclusion: Re-adjustable AVCDs with a resting pressure of around 40 mmHg are more effective in reducing
chronic venous edema than IBs with a resting pressure of around 60 mmHg. AVCDs are effective and well
tolerated, not only during maintenance therapy, but also in the initial decongestive treatment phase of patients
with venous leg edema.
Ó2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
Article history: Received 8 March 2015, Accepted 13 May 2015, Available online XXX
Keywords: Adjustable Velcro
Ò
compression device (AVCD), Compression therapy, Inelastic bandages, Leg edema,
Leg volume
DOI of original article: http://dx.doi.org/10.1016/j.ejvs.2015.05.015
* Corresponding author.
E-mail address: giovanni.mosti10@gmail.com (G. Mosti).
1078-5884/Ó2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ejvs.2015.05.014
Please cite this article in press as: Mosti G, et al., Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic Bandages in Reducing Venous
Edema in the Initial Treatment Phase: A Randomized Controlled Trial, European Journal of Vascular and Endovascular Surgery (2015), http://dx.doi.org/
10.1016/j.ejvs.2015.05.014
Eur J Vasc Endovasc Surg (2015) -,1e7

INTRODUCTION
To reduce leg edema, inelastic bandages (IBs) are usually
recommended for the initial treatment phase.
1,2
The dis-
advantages of IBs are that they lose pressure quickly
following application and need to be reapplied by special-
ized staff.
3,4
Elastic stockings, and particularly elastic kits, have been
shown to be effective, even in the therapy phase, achieving
similar edema reduction as IBs.
5,6
However, stockings may
be difficult to apply and are often not well tolerated during
the night.
The aim of this study was (i) to compare adjustable
Velcro
Ò
compression devices (AVCDs) with IBs in terms of
effectiveness in the treatment of venous edema; and (ii) to
assess patient comfort related to the two different
compression modalities.
METHODS
Patients
Forty legs from 36 patients (17 men, 19 women; mean SD
age 71.4 10.2 [range 52e85 years]) affected by chronic
leg edema due to chronic venous disease were randomized
to receive two different compression systems, to be applied
for 1 week: group A received IBs and group B received
AVCDs.
The following inclusion criteria were applied: patients
had to be 18e85 years age and affected by chronic lower
leg edema due to primary and/or secondary chronic venous
disease (CEAP C3EpsAdsPr) for >3 months.
Exclusion criteria included: patients with skin changes
due to venous insufficiency (CEAP C4eC6), clinical signs of
lymphedema (positive Stemmer’s sign at the base of the
toes), cardiac/renal failure, conditions requiring diuretics,
corticoids, Ca
þþ
antagonists, compression therapy in the
last 3 weeks, and an ankleebrachial pressure index <0.8.
Patients with venous edema were investigated with color
duplex ultrasound (Esaote MyLab 60 with a multi-frequency
linear probe of 7.5e12.0 MHz; Esaote s.p.a., Genoa, Italy),
according to the generally accepted recommendations.
7
Thirty-five lower limbs were affected by superficial venous
insufficiency (C3EpAsPr) and five by deep venous insuffi-
ciency (post-thrombotic syndrome) (C3EsAdPr). Patient
characteristics are summarized in Table 1.
All individuals were informed about the trial and gave
their written, informed consent.
Ethical committee consent for the study was also ob-
tained from the local health authorities.
The primary end point was edema reduction; secondary
outcome parameters were the interface pressure (IP) of the
compression device in the supine and standing position,
and the comfort of the compression systems reported by
the patient.
Compression
In group A patients a multilayer, multi-component IB con-
sisting of a cotton padding layer, a short stretch cohesive
bandage, and a short stretch non-adhesive bandage on top
was applied in a spiral fashion, with 50% overlap between
the layers, from the base of the toes up to 2 cm below the
knee. The bandages were applied under full stretch to exert
a supine pressure of around 60 mmHg, which is classified as
very strong according to the International Compression
Club’s classification of compression materials.
8
An AVCD
(Circaid Juxtafit
Ò
; Medi GmbH, Bayreuth, Germany)
adjusted to exert a pressure around 40 mmHg in the lying
position (moderate pressure) was applied to the patients in
group B.
8
Both compression devices were applied by well
trained and experienced staff that also measured the IPs.
While patients in the group A were instructed not to
manipulate their bandages during wearing time, patients in
group B were advised to readjust the Velcro
Ò
straps when
they felt a decrease or “loosening”of the compression
pressure.
Study protocol
Patients were randomly allocated to the treatment groups
using a list randomizer (http://www.random.org/lists/).
Venotonic drugs and compression devices, when used
routinely by the patient, were stopped at enrollment, 7
days before the start of the study (washout period), and
remained discontinued for the study period, during which
the patients were encouraged to maintain their usual
lifestyle.
On day 0 (T0) leg volume was calculated, and either IBs
or AVCDs were applied. Patients were asked to wear the
assigned compression device day and night. The IP of the
applied compression device was measured and the static
stiffness index (SSI) calculated. Patients were asked to fill
out the questionnaire assessing their subjective feelings
concerning compression comfort. On day 1 (T1), IBs and
AVCDs were removed, lower leg volume was measured
again, and the compression devices were reapplied. IP was
measured and SSI calculated before removing and after re-
applying the compression devices. The patients were asked
to fill out the comfort questionnaire.
Table 1. Case series demographic data.
Patients (n) Legs (n) Age (mean SD) Sex (n) BMI (mean SD) VD (n) LV (mean SD)
AVCD 19 20 72.7 8.4 10 F; 9 M 24.5 8.5 SVI: 14; DVI: 6 2,854 445
IB 17 20 71.2 11.4 9 F; 8 M 24.8 7.8 SVI: 15; DVI: 5 2,838 697
Note. The difference between groups is not statistically significant. BMI ¼body mass index; VD ¼venous disease; LV ¼leg volume;
AVCD ¼adjustable Velcro
Ò
compression device; IB ¼interface pressure; F ¼female; M ¼male; SVI ¼superficial venous
insufficiency; DVI ¼deep venous insufficiency.
2G. Mosti et al.
Please cite this article in press as: Mosti G, et al., Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic Bandages in Reducing Venous
Edema in the Initial Treatment Phase: A Randomized Controlled Trial, European Journal of Vascular and Endovascular Surgery (2015), http://dx.doi.org/
10.1016/j.ejvs.2015.05.014

On day 7 (T7), compression devices were removed after
IP and SSI assessment and the lower leg volume was
measured. The patients were again asked to fill out the
comfort questionnaire.
Outcome parameters
Patients were always seen at the same time of the day in a
quiet room, with a constant temperature of about 22 C.
Leg volume was calculated by measuring the lower leg
circumference with a tape starting immediately above
malleolar level and continuing measurements every 4 cm
for eight leg segments.
9
Using a specific Access based
computer program the leg volume was calculated using the
mathematical formula of the truncated cone (“Kuhnke for-
mula”).
10
All measuring points on the leg were marked at T0
to allow the repetition of the measurements at exactly the
same site at T1 and T7. Edema reduction (%) was calculated
by subtracting the volume at T1 and T7 from the baseline
volume at T0 in relation to baseline volume.
The IP between the compression devices and the skin
was measured in the supine and standing positions by
means of a pneumatic pressure transducer connected to a
pressure probe (Picopress
Ò
Microlab Italia, Padua, Italy).
The probe, 5 cm in diameter and <1 mm in thickness when
filled with 2 mL of air during measurement, was attached to
the skin at the B1 point and kept empty and in place for 1
week.
11
This device has been shown to provide accurate,
linear, and reproducible measurements.
12,13
SSI was calculated by subtracting the supine from the
standing pressure.
14
Patient perception of the compression system was
assessed using a visual analog scale (VAS) in accordance
with the outcome of an International Compression Club
meeting in Maastricht 2014 (http://www.icc-
compressionclub.com). Validation studies are in prepara-
tion. The following items were assessed: the wearing com-
fort of the compression devices (pain, heaviness sensation,
swelling sensation, edema related discomfort, itching,
restless leg), and parameters specifically related to the
compression device (application difficulty, symptoms wors-
ening, difficulty in wearing shoes, re-adjustment difficulty,
cosmetic appearance).
All these parameters were graded at T0, T1, and T7 using
a VAS. The absence of symptoms was graded 0, increasing
to 10 for the most severe symptoms. The sum of the first
block of symptoms was calculated in order to have a global
“comfort index”and, separately, the second block of
parameters.
Statistical analysis
Based on a previous study,
4
it was calculated that a sample
size of 20 patients per group would have a 90% power to
detect a difference between means of 5.59% volume
reduction with a significance level of .05 (two-tailed).
Medians with interquartile ranges (IQRs) and maximum
and minimum values are given. For repeated measures,
analysis of variance was used to compare the volume and
pressure changes on the same leg. The non-parametric
ManneWhitney test was used to compare the effects of
IBs and AVCDs. Differences with a p-value <.05 were
considered to be statistically significant.
The graphs and the statistical evaluations were generated
using GraphPad Prism, version 5 (GraphPad Inc., San Diego,
CA, USA).
RESULTS
There were no significant differences with regard to age,
sex, venous pathology, body mass index, or baseline leg
volume between the groups (Table 1).
Volume
Both compression systems achieved a significant reduction
of total lower leg volume at T1 and T7 compared with
baseline (p<.0001) (Fig. 1). In comparing the effects of the
different compression devices, AVCDs were significantly
more effective than IBs after both 1 and 7 days (p<.001),
with a median volume decrease of 19% and 26% for the
AVCD, respectively, and of 13% and 19% for the IB,
respectively (Fig. 2).
IP
Immediately after application, IP was significantly higher
with IBs compared with AVCDs, both in the supine (median
62.5 mmHg [IQR 60.2e64.7] vs. 43.0 mmHg [IQR 41.0e
45.0]; p<.0001) and standing positions (median
79.0 mmHg [IQR 75.0e84.0] vs. 50.5 mmHg [IQR 49.2e
54.7]; p<.0001).
Standing pressure was significantly higher compared
with lying pressure for both compression systems (Fig. 3).
After 24 h, IP dropped significantly under the IBs but not
under the AVDCs, resulting in a significantly lower pressure
with IBs in the supine position (median 21.5 mmHg [IQR
19.2e25.0] vs. 42.0 mmHg [IQR 41.0e44.5]; p<.001)
(Fig. 4). The corresponding standing values (data not
shown) were 29 mmHg (IQR 28e31.7) and 50.5 mmHg
(IQR 49.2e53.0), respectively (p<.001). Similar results
occurred after 1 week: after the second application the IB
pressure was again significantly higher than AVCD pres-
sure, both in the supine (median 62.0 mmHg [IQR 59.5e
65.5] vs. 43.0 mmHg [IQR 41.0e45.0 mmHg; p<.0001)
and standing positions (median 78.5 mmHg [IQR 78.0e
80.7] vs. 52.0 mmHg [IQR 50.2e55.5]; p<.0001). At T7,
before removal, the pressure of the IBs had dropped to a
median of 31.0 mmHg (IQR 28.5e34.0) in the supine po-
sition and to a median of 40.5 mmHg (IQR 35.7e43.7) in
the standing position in contrast to AVCD, which main-
tained pressure owing to re-adjustments by the patient. As
a consequence, the pressure of the AVCDs was significantly
(p<.0001) higher both in the supine (median 43 mmHg
[IQR 41e45]) and standing position (median 52.0 mmHg
[IQR 49.0e53.7]) (Fig. 4). The median SSI for the IBs was
17.0 (IQR 15.0e19.7) and 9.0 (IQR 8.0e10.0) for the
AVCDs (p<.0001).
Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic Bandages 3
Please cite this article in press as: Mosti G, et al., Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic Bandages in Reducing Venous
Edema in the Initial Treatment Phase: A Randomized Controlled Trial, European Journal of Vascular and Endovascular Surgery (2015), http://dx.doi.org/
10.1016/j.ejvs.2015.05.014

Patient comfort
The “comfort index”, derived from the sum of VAS figures
referring to pain, sensations of heaviness and swelling,
edema related discomfort, itching, and restless leg did not
show any statistical difference at baseline before
compression. The sum score decreased significantly with
both compression devices, from 15.0 (IQR 9.0e17.8) in
group A and 15.0 (IQR 5.0e18.5) in group B to 7.0 (IQR
3.3e9.5) and to 5.5 (IQR 0e10.0) at T1, respectively, and to
2.0 (IQR 1.0e4.0) and 2.0 (IQR 0e4.8) at T7, respectively
(p<.001), without any statistical difference between the
two compression modalities.
Regarding symptoms and parameters in relation to the
compression device, there was no worsening of symptoms
in any case, and application and re-application was
considered quite easy in group B (not applicable to group A,
where the IBs were wrapped by expert personnel).
Cosmetic appearance was judged to be better with AVCDS
(p<.05) along with the ease of putting on shoes
(p<.0001).
DISCUSSION
The classic recommendation for the treatment of leg edema
is to start with strong bandages for the decongestive
treatment and to switch to compression stockings for the
maintenance therapy phase. It was demonstrated in a
previous study that this concept is more based on economic
concerns than on differences regarding edema reducing
% oedema reduction
after 1 day
-50
-40
-30
-20
-10
0
% volum e decrease
*
Minimum
25% Percentile
Median
75% Percentile
Maximum
Mean
Std. Deviation
Std. Error
IB
-30.00
-16.75
-13.00
-10.25
-5.000
-14.30
6.182
1.382
AVCD
-29.00
-21.00
-19.00
-15.00
-10.00
-18.70
5.202
1.163
% oedema reduction
after 1 week
-50
-40
-30
-20
-10
0
%volumedecrease
**
Minimum
25% Percentile
Median
75% Percentile
Maximum
Mean
Std. Deviation
Std. Error
IB
-31.00
-23.50
-19.00
-16.00
-10.00
-19.76
6.156
1.343
AVCD
-41.00
-30.50
-26.00
-22.00
-12.00
-25.95
7.871
1.718
Figure 2. Percent edema reduction after 1 day and 1 week with inelastic bandages (IBs) and adjustable Velcro
Ò
compression devices
(AVCDs). *p<.01; **p<.001.
0
2000
4000
6000
ml
volume IB
Minimum
25% Percentile
Median
75% Percentile
Maximum
Mean
Std. Deviation
Std. Error
baseline
1903
2655
2750
3232
3755
2854
445.2
99.54
after 1 day
1724
2240
2393
2620
3240
2437
370.4
82.83
after 7 days
1657
2130
2221
2493
3110
2295
346.6
77.51
**** ****
0
2000
4000
6000
ml
volume AVCD
Minimum
25% Percentile
Median
75% Percentile
Maximum
Mean
Std. Deviation
Std. Error of Mean
baseline
2180
2281
2631
3200
4897
2838
697.2
155.9
after 1 day
1720
1822
2223
2665
3585
2296
498.2
111.4
after 7 days
1644
1754
1970
2358
2883
2077
366.0
81.84
**** ****
Figure 1. Leg volume in the inelastic bandage (IB) and adjustable Velcro
Ò
compression device (AVCD) groups at baseline, and after 1 and 7
days. ****p<.0001.
4G. Mosti et al.
Please cite this article in press as: Mosti G, et al., Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic Bandages in Reducing Venous
Edema in the Initial Treatment Phase: A Randomized Controlled Trial, European Journal of Vascular and Endovascular Surgery (2015), http://dx.doi.org/
10.1016/j.ejvs.2015.05.014

effectiveness.
5,6
In a recent study,
5
it was shown that
compression stockings exerting a pressure of about
30 mmHg at the ankle were nearly as effective as inelastic
compression bandages applied with an initial pressure of
60 mmHg with regard to edema reduction. However, in
daily practice new compression stockings would be needed
after a few days because of the reduction in leg size, which
would be economically unfavorable. In this study, only C3
patients were enrolled in order to obtain results not biased
by different underlying pathologies. However, from a prac-
tical point of view the measured volume reduction of
swollen limbs may also be expected in patients with C4eC6,
and also in those with lymphedema.
It has been shown in patients with lymphedema that
AVCDs can be applied and readjusted correctly, after short
didactic demonstration, by the patients themselves.
15
This
led, after 1 day, to a significantly greater reduction in leg
volume compared with lymphedema bandages. To date, the
present results provide the only quantitative data in the
literature regarding the efficacy of AVCDs on leg edema. It
has been demonstrated in the present study that AVCDs, re-
adjusted by the patients when needed, achieved a signifi-
cantly more pronounced reduction of venous edema than
IBs, not only after 1 day, but also after 7 days.
As shown in Fig. 4, there is a drop in IP under IBs of >
50% after 1 day, which is in contrast to AVCDs, where the
pressure is maintained owing to re-adjustment by the pa-
tient. The same happens a few days after the re-application
of the bandage. As shown in a previous study, the pressure
loss under the IBs is mainly due to a volume reduction of
the leg.
3
The consistently higher pressure exerted over time
by the AVCDs compared with the IBs might explain its
greater effectiveness.
Proper self-application may be difficult, especially in very
overweight patients and in those with severe disfiguration
of the legs. Such patients were not seen in the present
series. As long as the patient is able to put on shoes and
handle shoe laces, an AVCD can be used. Proper education
or help from relatives may overcome potential problems.
Despite high pressure on the leg, distal swelling of the
ankle and foot due to a tourniquet effect was not observed
in the present series, demonstrating that the tubular device
and the half-stocking provided with the ACVD is sufficient to
prevent foot swelling. Minor swelling of the uncovered
parts, which may occur in the morning after waking up,
disappears as soon as the patient starts to walk. Some
methodological points to be discussed relate to the
methods of measurement: edema reduction was calculated
by subtracting leg volume after 1 and 7 days from the
baseline volume, which was calculated by the truncated
cone formula.
10
This method of assessing leg volume
showed good reproducibility,
9,16
and an excellent correla-
tion with volumetry assessed by water displacement
(Pearson’sr¼.983; 95% confidence interval 0.96e
0.99),
6,17,18
which is considered the gold standard tech-
nique, with good accuracy and reproducibility.
17,19,20
In
contrast to water displacement, the method used does not
include foot volume.
Measurements of IP and SSI using a Picopress probe,
which can be left on the same site day and night, has
become a standard method in clinical compression
studies.
4e6,21
This method revealed that the average pres-
sure over time is higher with AVCDs than with IBs. The SSI
was significantly higher for the IBs compared with the
AVCDs, showing that the Circaid Juxtafit material is more
elastic. As a consequence of this study, it is proposed that
AVCDs can be used effectively for the initial treatment of
venous edema. The superiority of AVCDs over IBs is mainly
based on the fact that they can be handled and readjusted
quite easily by the patients themselves. This is an important
step in the direction of self-management, with the obvious
limitation of the patient’s cooperation.
Concerning the subjective perception of the compression
devices, both devices were well tolerated. Patients did not
complain about cosmetic appearance, and the ability to
wear shoes was significantly better with AVCDs.
Concerning the re-application of IBs, the present study
reflects a realistic scenario. Usually, such bandages are left
on the leg day and night for a period of 1 week, during
which bandage renewal may be recommended when it is
getting loose. This bandage loosening is due to a reduction
in edema, which is most pronounced immediately after
bandage application.
3
The renewal of the bandage after 1
day seems to be an appropriate regime, as at that time the
pressure will have already dropped to more than half.
However, the optimal timing for renewing bandages needs
further investigation.
21
A weak point of this study is the lack of a fair comparison
in the timing of IB and AVDC renewal. Nevertheless, in
0
20
40
60
80
100
mmHg
IB and AVCD pressure
supine standing
Minimum
25% Percentile
Median
75% Percentile
Maximum
Mean
Std. Deviation
Std. Error
IB
55.00
60.25
62.50
64.75
68.00
62.05
3.591
0.8029
AVCD
39.00
41.00
43.00
45.00
48.00
43.05
2.502
0.5595
IB
69.00
75.50
79.00
84.00
87.00
79.40
4.957
1.108
AVCD
46.00
49.25
50.50
54.75
60.00
51.90
3.432
0.7674
P <0.0001 P <0.0001
Figure 3. Supine and standing pressure with inelastic bandages
(IBs) and adjustable Velcro
Ò
compression devices (AVCDs).
Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic Bandages 5
Please cite this article in press as: Mosti G, et al., Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic Bandages in Reducing Venous
Edema in the Initial Treatment Phase: A Randomized Controlled Trial, European Journal of Vascular and Endovascular Surgery (2015), http://dx.doi.org/
10.1016/j.ejvs.2015.05.014

clinical practice the AVCD is adjusted, not just after the first
24 h, but more frequently: the re-adjustment of the Velcro
Ò
straps by the patients according to the subjective feeling is
a successful arrangement.
However, comparing a daily re-adjusted AVCD with a
daily re-wrapped IB could produce different results, with a
possible improvement of the overall efficacy of the IB, but
the socio-economic burden of this daily re-bandaging
regime by trained personnel would be extremely high.
The reported results have some practical and economic
implications. Usually, edema treatment starts with IBs,
which need to be applied by expert personnel; then, elastic
stockings are used after decongestion to maintain results
and prevent recurrences. With this new approach only one
device needs to be usedda device that is self-applicable
after short training, and self re-adjustable. Even when leg
volume is reduced by the initial treatment phase the device
can be resized to adjust it to the new leg volume, allowing
considerable cost savings. The AVCD can be washed and
reused by the patient. It can be cut and adjusted to the new
leg size so that the same device can be utilized not only in
the maintenance phase, but also in the therapy phase for
several months. The most important factor concerning po-
tential cost saving is not the price of the device but its
applicability without needing trained medical staff. How-
ever, studies on cost-effectiveness should be carried out in
the future, comparing the lifetime and usability of inelastic
materials with that of AVCDs.
0
10
20
30
40
50
60
70
mm Hg
AVCD supine pressure
Minimum
25% Percentile
Median
75% Percentile
Maximum
Mean
Std. Deviation
Std. Error of Mean
application
39.00
41.00
43.00
45.00
48.00
43.05
2.502
0.5595
after 1 day
39.00
41.00
42.00
44.50
51.00
43.05
3.187
0.7126
0
20
40
60
80
mm Hg
IB supine pressure
Minimum
25% Percentile
Median
75% Percentile
Maximum
Mean
Std. Deviation
Std. Error of Mean
application
55.00
60.25
62.50
64.75
68.00
62.05
3.591
0.8029
after 1 day
17.00
19.25
21.50
25.00
31.00
22.60
4.147
0.9274
20
30
40
50
60
mm Hg
AVCD supine pressure
Minimum
25% Percentile
Median
75% Percentile
Maximum
Mean
Std. Deviation
Std. Error of Mean
2° application
39.00
41.00
43.00
45.00
47.00
42.90
2.469
0.5520
after 5 days
38.00
41.00
43.00
45.00
48.00
42.95
2.625
0.5870
0
20
40
60
80
mm Hg
IB supine pressure
Minimum
25% Percentile
Median
75% Percentile
Maximum
Mean
Std. Deviation
Std. Error of Mean
2° application
55.00
59.50
62.00
65.50
68.00
62.33
3.825
0.8348
after 5 days
19.00
28.50
31.00
34.00
38.00
30.62
4.610
1.006
first applicaƟon
second applicaƟon
Figure 4. Supine pressure loss after the first (top) and second application (bottom) of inelastic bandages (IBs) and adjustable Velcro
Ò
compression devices (AVCDs).
6G. Mosti et al.
Please cite this article in press as: Mosti G, et al., Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic Bandages in Reducing Venous
Edema in the Initial Treatment Phase: A Randomized Controlled Trial, European Journal of Vascular and Endovascular Surgery (2015), http://dx.doi.org/
10.1016/j.ejvs.2015.05.014

CONCLUSIONS
In patients with chronic venous leg edema, a compression
pressure in the range of 40 mmHg exerted by an ACVD is
more effective in reducing chronic venous edema than an IB
with an initial resting pressure of around 60 mmHg, with
comparable patient comfort. This AVCD based approach
could allow a considerable cost saving due to self-
management, thereby avoiding costs associated with
specialized medical staff.
CONFLICT OF INTEREST
None.
FUNDING
None.
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Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic Bandages 7
Please cite this article in press as: Mosti G, et al., Adjustable Velcro
Ò
Compression Devices are More Effective than Inelastic Bandages in Reducing Venous
Edema in the Initial Treatment Phase: A Randomized Controlled Trial, European Journal of Vascular and Endovascular Surgery (2015), http://dx.doi.org/
10.1016/j.ejvs.2015.05.014