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218 Foam Treatment of Venous Leg Ulcers: A Continuing Experience
is asked to fl ex and extend the foot forcefully to contract the gastrocne-
mius-soleus muscles. Resultant deep venous blood fl ow clears these veins
of foam particles. Then the treated lower extremity is elevated for 5 to 10
minutes, during which time the foam returns to its liquid state. This avoids
adverse events such as migraine, scotomata, chest pain, and dry cough.
A fi tted 30–40-mmHg compression stocking is applied and reinforced
with elastic bandaging. Focal pressure with gauze pads, dental rolls, or
foam rubber under the bandaging but over the stocking is carefully applied
to empty and keep empty those vessels that might trap blood in the post-
treatment period. Careful attention to the details of focal pressure will
ensure successful fi brosclerotic sealing of the affected veins and absence
of blood trapping. The elastic wrap needs to include the foot and heel to
prevent distal edema. The pressure dressing is left in place 72 hours or
longer before it is removed. The patient is instructed to wear the compres-
sion stocking without overwrap during the day for an additional 2 weeks
and to abstain from heavy lower extremity exercise.
STATISTICAL ANALYSIS
Data points for patients treated from August 2001 through August 2006
were established for gender, age, venous clinical severity score (VCSS)
before/after treatment, and duration of treatment. The VCSS is based on
nine clinical characteristics of chronic venous disease. They are graded 0
to 3 (absent, mild, moderate, severe) with specifi c criteria to avoid overlap
or arbitrary scoring. Zero to 3 points were added for differences in previous
conservative therapy (compression, elevation) to produce a 30-point
maximum fl at scale. Ulcer healing is defi ned as the time for a lesion to stop
producing exudate.
The unpaired, two-tailed Student’s t-test was performed to determine
differences between two experimental groups. Values are reported as mean
±SD, and p < 0.05 was considered statistically signifi cant.
RESULTS
Group I included 17 extremities that were treated only with compres-
sion. Group III included 14 extremities that had treatment with foam
sclerotherapy without preliminary prolonged compression. Group II
included those patients who were initially managed with compression but
later crossed over to be treated with sclerosant foam (Figure 16-3). The
analysis of these patients will be observational and is discussed later.
Patients in Groups I and III were evenly matched for age and gender.
Six of the 17 extremities in Group I were post-thrombotic, compared with
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Foam Treatment of Venous Leg Ulcers: A Continuing Experience 219
fi ve of the 14 extremities in Group III, which were post-thrombotic (Table
16-1). Group I had an average VCSS score of 17.8, which was reduced to
8.9 after treatment. This resulted in a change of 8.9. Group III had an
average pretreatment VCSS score of 20.4, which dropped to 7.4 after treat-
ment, resulting in a change of 12.6 ± 4.2 (Figures 16-4A and 16-4B). It
was determined that the change in VCSS between those treated with
foam versus those treated with compression was statistically signifi cant
(p = 0.02).
FIGURE 16-3 This photograph of a recalcitrant venous leg ulcer is typical of lesions
that crossed over from Group I to Group II. Its classifi cation is C
6s
for unhealed symptomatic
leg ulcer, E
s
for post-thrombotic or secondary, A
S,rDr,Pr
for the refl uxing superfi cial deep and
perforating vein venous systems, and, fi nally, P
r
for Pathophysiological refl ux. After 6 months
of unsuccessful treatment in an unna boot, the ulcer healed after 6 weeks and two sessions
of foam sclerotherapy.
TABLE 16-1 Characteristics of the Treatment Groups
Group I Group III
Male gender 58% 57%
Age (years)
65 ± 19.4 68 ± 14
VCSS (before) 17.7 20.4
VCSS (after) 8.9 7.4
Change in VCSS
−8.9 −12.6
Duration of ulceration 9.2 weeks 4.3 weeks
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220 Foam Treatment of Venous Leg Ulcers: A Continuing Experience
Patients had ultrasound studies at 1 week and 1 month post sclerother-
apy, during which time further injections were made of the residual refl ux-
ing veins as needed. At the conclusion of these treatments, the previously
refl uxing veins were not compressible and had no fl ow by ultrasound
examination.
The time of healing from initiation of treatment to complete healing of
the foam treatment group was, on average, 4 weeks. Compared with the
FIGURE 16-4 These photographs show the medial leg ulcers that were present for over
2 years in an otherwise healthy 92-year-old woman with an ancient history of great saphe-
nous stripping. A. This photograph shows the clean ulcers on initiation of foam therapy.
B. This photograph shows the ulcers at 14 days after injection of foam when the ulcers had
begun circumferential healing. The ulcers were healed at 28 days.
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Foam Treatment of Venous Leg Ulcers: A Continuing Experience 221
duration of time from initiation of treatment to complete healing in the
compression group (9 weeks), the difference was statistically signifi cant
(p = 0.027).
Group II patients initially received treatment with compression.
However, when standard therapy failed to heal the ulcers, these patients
received foam sclerotherapy. The mean age of this group was 64.6 years,
and fi ve of the eight had primary venous insuffi ciency, while three were post-
thrombotic. They had an average VCSS of 16.4 on initiation of foam treat-
ment, and this improved to a score of 7 after complete healing. This statistic
included one patient who did not respond to compression or sclerosant
foam. His venous clinical severity score remained at 17 despite all interven-
tions. Later, he was subjected to resection of an aortic aneurysm and had
a femoro-tibial bypass to revascularize diabetic tibial artery occlusions.
No major complications were observed. There were no temporary or
permanent neurological defi cits, no DVT or pulmonary emboli, and no
visual abnormalities. The previously rare events of dry cough, visual dis-
turbance (<1 minute), and migraine were eliminated after post-treatment
leg elevation of the treated extremity was included in the protocol. The
single adverse reaction that remained troublesome was discoloration of the
skin overlying treated veins. This problem generally resolved within 6
months. Calculation of the recurrence rate will be ascertained and reported
in a future paper.
DISCUSSION
It has been pointed out that venous ulceration occurs in a small propor-
tion of the population, but this cohort commands considerable health care
resources to manage the problem.
12
Venous ulcers tend to run a prolonged
course, taking a number of months to achieve complete healing. Roughly
half of patients attending a leg ulcer service will achieve ulcer healing
within 4 months, while half will not.
13
Healing is often followed by relapse.
The ulcer recurrence rate ranges from 15% to 70% with 3% to 28% recur-
ring within 1 year. Controlling superfi cial refl ux by ablation of superfi cial
veins can reduce ulcer recurrence. One careful study has shown that the
ulcer recurrence rate was 28% with compression alone, but this was reduced
to 12% when surgical stripping was added to compression therapy.
14
Details
regarding this study are found in Chapter 13.
Despite various methods of treatment, venous leg ulcer is characterized
by recurrence (Table 16-2). Well-performed surgery in which attention is
paid to total ablation of superfi cial refl ux and perforator outfl ow has the
lowest rate of recurrence. Conversely, when the ulcerated surface is covered
without attention to the abnormal hemodynamics that produced the defor-
mity, the rate of recurrence is the greatest. This experience is replicated in
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222 Foam Treatment of Venous Leg Ulcers: A Continuing Experience
wound care centers worldwide where attention is paid to the effects of
abnormal venous pressure rather than its causes.
Abnormal venous pressure is associated with a cascade of infl ammatory
events that seriously damage tissues such as venous valves, venous walls,
subcutaneous tissues, and skin
21
(Figure 16-5). The venous system of the
lower extremities in man is exposed to high pressures. A mean pressure of
95.4 ± 5.5 mmHg was recorded by Kügler in dorsal foot veins during quiet
standing in a group of 20 healthy volunteers.
22
Similar values were recorded
by Stick.
23
Some vessels in the calf, including the perforating veins, are
subjected to even higher pressures, which are generated by calf muscle
contraction. Peak intramuscular pressures in the human soleus muscle
TABLE 16 -2 Recurrence of Leg Ulcer According to Treatment Received*
Report Treatment Recurrence Follow Up
Hansson
15
Surgery 5% 5 years
Henry
16
Sclerotherapy 30% 5 years
Porter
17
Compression 29% 5 years
Hansson
18
Miscellaneous 44% 3 years
O’Donnell
19
Perforator Ligation 55% 5 years
Reiter
20
Skin Grafts 71% 2.5 years
* All patients treated with ancillary compression.
Modifi ed from Coleridge Smith PD. Chapter 2. In: Negus D, Coleridge Smith PD,
Bergan JJ, eds. Leg Ulcers, 3rd ed. London: Hodder Arnold, 2006:12.
FIGURE 16-5 This diagram shows how proximal venous pressure transmitted through
superfi cial refl ux and muscular contraction pressure through incompetent perforating veins
is delivered to the tangle of veins under lipodermatosclerotic skin and the venous ulcer.
From DePalma RG. In: Bergan JJ, Gloviczki P, eds. Atlas of Endoscopic Perforator Vein
Surgery. London: Springer-Verlag, 1997.
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Foam Treatment of Venous Leg Ulcers: A Continuing Experience 223
have been recorded as 181 mmHg during walking and 269 mmHg during
running.
24
Proximal venous valves may be exposed to high pressures generated
within the abdomen. This intra-abdominal pressure is transmitted to groin
vessels, the common femoral vein, the great saphenous vein, and the pro-
funda femoris vein. These pressures have been reported in healthy adults
to reach 107 mmHg during coughing and 171 mmHg during jumping.
25
In the normal human lower extremity venous system with competent
valves and a functioning calf muscle pump, high pressures are experienced
only intermittently. However, when proximal valves are damaged or
destroyed by the infl ammatory effects of abdominal pressure impulses,
high pressures are transmitted distally. Eventually, high pressures reach
the subulcer tangle of venules where the tissue-destructive actions of the
infl ammatory cascade wreak havoc. High pressures transmitted through
incompetent perforating veins also reach the veins under the ulcer. Sum-
mation of these forces explains the failure of ulcer treatment and the
reasons for recurrence of venous ulcer after successful compression and/or
surgical treatment.
De Palma’s solution, and that of many surgeons, is to excise the entire
ulcerated area down to and including the deep fascia. This does effectively
remove the end organ of ulcer genesis, the tangle of subulcer venules. A
subsequent skin graft would be predicted not only to heal the ulcer bed
but also to prevent ulcer recurrence. Experience teaches that ulcer recur-
rence after successful ulcer excision and skin grafting is at the edges of the
graft in tissue that continues to be pressurized by superfi cial refl ux or
perforator outfl ow. It is not surprising that ulcer recurrence occurs most
frequently in limbs with previous deep vein thrombosis where the throm-
botic process has destroyed deep valve function and may leave behind a
degree of venous outfl ow obstruction that perpetuates the destructive
forces of distal venous hypertension.
The rapid success of foam sclerotherapy in treatment of venous ulcers
is easily explained by the fact that its effect is directly on the subulcer veins
rather than indirect as in subfascial perforator interruption and vein strip-
ping. The target venules under the ulcer are easily visualized during the
administration of foam sclerotherapy. They are seen to be closed and unre-
sponsive to transducer pressure after ulcer healing. The same effects are
seen in treating severe lipodermatosclerosis and atrophie blanch.
CONCLUSIONS
Foam sclerotherapy reaches its highest pinnacle of success in treating
venous leg ulcer. This is easily explained by the fact that the tangle of pres-
surized veins that cause and perpetuate the leg ulcer are closed by the
actions of the foamed sclerosant.
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224 Foam Treatment of Venous Leg Ulcers: A Continuing Experience
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815–825.
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Foam Treatment of Venous Leg Ulcers: A Continuing Experience 225
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227
17
Ultrasound Guidance
for Endovenous
Treatment
Luigi Pascarella, Lisa Mekenas, and
John J. Bergan
INTRODUCTION
Duplex ultrasound sonography is the best choice for evaluation of venous
refl ux in the lower extremities.
1
It is inexpensive, noninvasive, and gener-
ally acceptable to the patient.
2
It provides direct visualization, localization,
and quantitation of venous refl ux with a surprisingly high sensitivity (95%)
and specifi city (100%).
3
Duplex ultrasound fi ndings have been confi rmed
by angioscopic observation of incompetent vein valves in advanced chronic
venous insuffi ciency.
4
Yamaki has demonstrated that high peak refl ux
velocities (>3 0 cm/s econd), refl ux duration greater than 3 seconds, and an
enlarged valve annulus measured by duplex ultrasonography at the SFJ are
all closely related to angioscopically deformed and incompetent terminal
valves (Type III and Type IV of Hoshino).
4
PREOPERATIVE ASSESSMENT
The examination should always begin with the recording of a complete
medical history. A family and personal venous history are of great impor-
tance. Symptoms such as aching heaviness, limb fatigue, itching, and
burning pain are typically present. History of pregnancy deliveries, limb
trauma, fractures, and confi ning illnesses should be recorded. Any history
of deep venous thrombosis and treatment must be paired with its method
of diagnosis. A detailed description of previous venous treatments must be
Venous Ulcers
Copyright © 2007 by Academic Press, Inc.
All rights of reproduction in any form reserved.
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