3. The treatment of chronic venous disease (CVD) and its complications
can be frustrating. CVD can be defined as an abnormally function-
ing venous system caused by venous valvular incompetence with or
without associated venous outflow obstruction.The accepted statistics
indicate that aVenous Leg Ulcer (VLU) requires an average of 24 weeks
to heal; approximately 15% never heal; and recurrence is found once or
multiple times in 15%–71% of cases. (1,2) In reported populations of
venous ulcers, 15%–71% are found to be recurrent lesions. (3) Healed
ulcerations possibly can have a five year recurrence rate as high as
40%. (4)With a diabetic foot ulcer, the accepted endpoint for healing is
12 weeks, while with aVLU it is 24 weeks.
A detailed history should be performed, especially if there is a healed
or active ulcer. If there is a current venous ulcer, a physical exam with
descriptive terms is important.The exam should be done with both
the patient being supine and standing.Venous Dilatation should be
described and examined by both visualization and palpation. Descrip-
tion of a dilated vein can range from telangiectases to reticular veins
to varicose veins. Edema indicates that the disease has progressed and
is functionally advanced.The extent of the edema should be described
and the limbs should be circumferentially measured. Skin Pigmen-
tation changes such as venous eczema and lipodermatosclerosis are
important signs of severe chronic disease. Any and all pigmentation
changes should be described. Venous Ulceration is the sign of the
most advanced disease.The location and the measurement of the
ulcer should be well described along with any healed ulcers that have
any scarring. Venous RefillTime provides an overall measurement of
venous reflux.
A comprehensive venous duplex scan and ultrasound of the lower ex-
tremities should be performed for all patients with significant venous
disease, especially patients with venous ulceration.The information
gained from the evaluation is helpful for classifying the anatomic
cause.The evaluation should be a complete mapping of the deep and
superficial venous systems, from the inguinal ligament to the foot.
There are three systems of veins in the lower extremities:
deep, superficial, and perforating.The anatomy and physiology of
each of the three venous systems need to be evaluated.The great
saphenous, small saphenous, intersaphenous, accessory saphenous
and all incompetent perforating veins are sized and the diameters
are recorded.The absence and/or closure of a great saphenous vein or
small saphenous vein from a previous surgical procedure should also
be noted. Areas of acute or chronic thrombosis, scarring or thickening,
tortuosity, and reflux are marked. If incompetent perforating veins are
found, their location and size are noted.The location and vein of origin
of all varicose clusters are noted as well.The deep venous system is
evaluated for thrombosis, scarring, and reflux. Non-Invasive Arterial
tests such as ABI’s and PVR’s should be done.
In 1994 an international consensus conference was held at the Ameri-
canVenous Forum to develop a new classification system of (CVD).The
CEAP classification was developed and implemented. (5) It is broken
down into 4 components:
Clinical Classification:There are seven clinical classes from 0 to 6, with
0 being no disease, 1 with signs of telengecstatis or reticular veins, 2
varicose veins, 3 edema without skin changes, 4 skin changes that are
associated with venous disease, 5 skin changes with healed ulcers and
6 skin changes with active ulceration.
Etiologic Classification:The type of dysfunction is classified as either
congenital, primary, or secondary. Congenital are noted at birth, but
don’t manifest till later in life. Primary dysfunction is of an unknown
cause, while secondary dysfunction is an acquired condition such as a
DVT.
Anatomic Classification: Anatomic sites of venous disease are either su-
perficial, deep, and/or perforating. Either one system or all the systems
can be involved in the same time.
Pathophysiologic Classification: Signs or systems of CVD result from
reflux, obstruction or both.
This classification system is very detailed and can be used to direct
treatment for surgical versus conservative treatment.The one fault of
the system is that there is no classification for other concurrent con-
ditions that might affect the severity or treatment of CVD. Important
considerations for other diseases such as diabetes and lymph-edema
need to be taken into account because they might affect the treatment
and healing times.
Healing and Treatment
When compared with Diabetic Foot Ulcers (DFU), healing and treat-
ment forVLU’s presents with significant variability.The following
are predictors for venous leg ulcers not healing: ulcer size ≥ 10 cm2,
duration ≥ 12 months, history of venous ligation or venous stripping,
history of hip or knee replacement surgery, ABI of < 0.80, and the
presence of fibrin on more than 50% of the wound surface for 24-week
healing.These were taken from a large retrospective study done by
Margolis. ( 6, 7) Similar to Sheehan’s diabetic foot ulcer study, the data
suggests that a venous leg ulcer that fails to decrease in size by 30% of
its initial size over the first 4 weeks of treatment has a 68% probability
of failing to heal within 24 weeks. (8,9)
The treatment options can be broken down to a few of categories: com-
pression, local wound care, surgical intervention, medical treatment
and advanced technology.
An analysis of the Cochrane review, a database of systemic reviews and
meta-analyses which summarize and interpret the results of medical
research, was conducted.The Cochrane Library aims to make the
results of well-conducted controlled trials readily available and is a key
resource in evidence based medicine.
According to the Cocharane review, multi-layered compression is the
gold standard for treatingVLUs.The database reviewed 39 random
controlled trials and asked two questions, whetherVLU’s healed more
rapidly with compression than without and if single layer compres-
sion gave better results than multi-layered compression.The authors
concluded that multi-layered elastic compression increased healing
rates. (10)The amount of compression typically should provide 30–40
mm Hg at the ankle, although compression pressure should be reduced
in the setting of peripheral arterial disease (ABI < 0.8–0.7, use reduced
compression pressure; < 0.7, compression relatively contraindicated).
When evaluating various dressings such as hydrocolloids, foams,
alginates, and hydrogels, there were no significant healing rates of
any dressings with compression. (11) Honey also showed no improved
healing. (12)Various skin grafts have been compared: xenografts,
frozen allografts, cultured keratinocyte grafts, and bilayered bio-engi-
neered grafts. Skin autografts are the gold standard. Only the bilayered
bio-engineered grafts increase venous ulcer healing. (13) It would be
beneficial to use the bio-engineered tissue after edema and exudate
are controlled and there is a healthy granular base.
Some medications have been administered for the treatment ofVLUs.
Oral zinc has been used, but there was no significant improvement.
(14)Various oral and topical antibiotics have demonstrated mixed
results, with topical cadexomer iodine showing the most promising im-
pact. (15)The best medication, oral or topical, is pentoxifylline. It is the
only medication to be shown as an effective adjunct to compression.
(16)
In a recent review of the impact of debridement on venous leg ulcer
healing, ulcer surface area reduction was accelerated in visits after
debridement. (17) Attention should be paid to removal of all necrotic
tissue, densely adherent slough and exudates, and reshaping of the
ulcer margins.
There are advanced modalities or machines that can be used to treat
venous leg ulcers in conjunction with compression. Intermittent
compression pumps have shown to be beneficial.The evidence is not
completely clear whether the devices can be used instead of elastic
bandage compression, but there are published studies to show that
when used in conjunction with bandages, increased healing was
demonstrated. (18)
AOTI’s Reusable Extremity Chamber
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over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial.
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As we know, Oxygen (O2) is essential to wound healing. Local tissue
hypoxia, caused by disrupted or compromised vasculature, is a key
factor that limits wound healing. (21) Clinical use of O2 to promote
wound healing began in the 1960s with the administration of systemic
full body hyperbaric oxygen therapy (HBO) to treat wounds. (22)
Today, HBO is usually administered in single- or multiplace chambers
utilizing pressures of 2,500 mb and higher.There has been only one
study on venous ulcers which indicated a significant reduction in
wound area at 6 weeks following the administration of HBO. (23)
Challenges and adverse events resulting from HBO include complica-
tions such as ruptured tympanic membrane, sinus irritation, oxygen
and pressure induced pulmonary toxicity, temporary worsening of
short-sightedness, Central Nervous System (CNS) oxygen toxicity and
claustrophobia. Although serious adverse events are rare, systemic HBO
cannot be regarded as an entirely benign intervention. Furthermore,
HBO in the treatment of recalcitrant ulcers requires transportation
to the treatment site (RCTs suggest 38 dives required over a 7 week
period) and is associated with a significant increase in cost. Any cost/
benefit advantage should be carefully considered. (24)
Cyclically pressured, humidified oxygen (TWO2) applied topically to
the open wound bed has demonstrated similar and possibly more
beneficial results.The traditional limitations of a full body hyperbaric
chamber have been overcome by an approach that allows the topical
application of humidified oxygen directly to the open wound, at above
ambient pressure cycled between 4 and 38mmHg every 35 seconds,
to only the specific wound site, in the home setting.This maximizes
the beneficial wound healing effects while avoiding the inconvenience
and cost of transportation and minimizing the negative systemic side
effects seen in traditional HBO. (25)The intermittent cycled pressure,
under whichTWO2 is delivered, enhances circulation, reduces edema
and provides a sealed humidified environment essential for healing.
(26)TWO2 promotes epithelialization and capillary angiogenesis. (27)
This leads to higher tensile strength collagen being formed during
wound healing, which reduces scarring and the risk of recurrence. (28)
TWO2 therapy reduces wound bed hypoxia, promoting the antimi-
crobial effect of ROS and the respiratory burst, and improving the
signal transduction pathway through increases in cellular mediating
biomarkers such as FGF for collagen formation andVEGF promoting
neovascularization (angiogenesis) (29,30).
Tawfick et. al, conducted a pivotal Level II study comparingTWO2
(study group) with elastic compression dressings (control group).The
following is a summary of their study: Patients with CEAP C6,sVLUs,
assessed by duplex ultrasonography, were managed with eitherTWO2
(n=46) or conventional compression dressings (CCD) (n=37) for 12
weeks or until full healing. Patients were followed up at 3 monthly
intervals.The results at 12 weeks revealed that 80% ofTWO2 managed
ulcers were completely healed compared to 35% of CCD ulcers (p <
0.0001). Median time to full healing was 45 days inTWO2 patients
and 182 days in CCD patients (p < 0.0001).The pain numerical rating
scale (PNRS) threshold inTWO2 managed patients improved from 8 to
3 within 13 days. After 12-month follow-up, 5 of the 13 healed CCD
ulcers demonstrated signs of recurrence while none of the ulcers
closed usingTWO2 had recurred. (31)
Surgical management ofVLUs has its role. Surgical intervention can
be proactive to prevent venous ulcers, as s treatment to help unhealed
venous ulcers, and help with prevention of recurrence. (32,33)
The algorithm is divided into evaluation and treatment ofVLUs. On the
left side of the algorithm describes a complete work up including stud-
ies to test both the venous and arterial system.The treatment portion
is based on high level evidence of what has been shown to work.This
evidence is based on either articles with Level 2 or better evidence and/
or using the Cochrane database. By following the algorithm, patients
have a higher likely hood that their ulcer will heal and possibly not
come back.
