Circulator
Boot Efficacy and Effectiveness in Clinic Practice
The
Circulator Boot has been used successfully for more than 25
years to produce healing in patients with chronic recalcitrant
ulceration and related conditions due to vascular insufficiency
of the feet. There is a growing number of clinicians actively
using the technique as the first treatment of choice. Hundreds
of limbs have been saved and many lives saved. It has FDA
listing in the USA and TPP listing in Canada.
Discussion
Documented
evidence 1, 2, 3, 4 shows that the Circulator Boot treatment
method is effective as claimed. Its efficacy as a treatment
modality — and its overall effectiveness in practical
clinical settings along with appropriate wound care and infection
control — has been conclusively established as follows:
1.
When only one of the patient's legs is treated, the contra
lateral leg serves as the control. It functions in the same
environment as the treated leg, with the only difference being
that the treated leg receives Circulator Boot therapy. It
is well documented that the control leg deteriorates further
while the treated leg improves.
2.
Previous clinical experience shows that a low oxygen level
in the tissues produces ulceration and prevents healing in
all cases 4. Where the transcutaneous oxygen tension (tcPO2)
is below 20 mm Hg, healing is impossible with all other methods,
but with the Circulator Boot most patients show successful
outcomes.
3.
Pneumatic pressure devices have been in use for at least 190
years to treat patients with poor circulation. During this
time the equipment has been continually improved to make use
of new materials, more accurate sensors and better electronics.
Clinicians have repeatedly refined the techniques to take
advantage of medical advances such as antibiotics and topical
oxygen. The healing process with the Circulator Boot is well
characterized and understood. The central concept of using
cardiosynchronous end-diastolic pneumatic compression to increase
blood flow to the extremities is self-evident and logical.
4.
Published literature gives a great deal of information on
the biochemical nature of the healing process that fully supports
the scientific basis of the Circulator Boot.
5.
Detailed published clinical data 3, 4 is available that documents
the progress of patients who have received Circulator Boot
treatment. These patients had typically received maximum attention
using conventional wound care methods as first line therapy;
yet their condition deteriorated. Upon commencement of Circulator
Boot treatment, as the second line therapeutic modality, their
condition quickly started to improve. Healing continued during
and after treatment. It is concluded therefore that effectiveness
is positively established with sufficient documented strength
of evidence for its listed indications at a Quality of Evidence
II-2 and a Classification of Recommendation A, using the ranking
of the Canadian Task Force on Preventive Health Care. The
Circulator Boot is recommended as appropriate and cost-effective
for use as a therapeutic modality in treating lesions of the
feet and legs where high clinical intensity is needed.
Recommendations
1.
End-diastolic compression using the Circulator Boot should
be recommended for patients presented with vascular insufficiency
in the lower extremities.
2.
Compression bandages, pressure offloading, wound management
therapy and exercise should be used.
3.
Circulator Boot treatment should commence as soon as practicable
when there is no healing response for 30 days or if there
is evidence of infection.
4.
The Circulator Boot should be considered prior to any surgicial
procedures including angioplasty, resection and amputation.
5.
After healing, patients should be instructed and encouraged
to maintain adequate nutrition and an exercise program to
help prevent re-occurrance of symptoms.
References:
1.
Koch CA. External leg compression in the treatment of vascular
disease. Angiology 1997; 48: S3-15.
2.
Dillon
RS. Patient Assessment and examples of a method of treatment.
Use of the circulator boot in peripheral vascular disease.
Angiology 1997; 48: S35-58.
3.
Dillon
RS. Fifteen years of experience in treating 2177 episodes
of foot and leg lesions with the circulator boot. Results
of treatment with the circulator boot. Angiology 1997; 48:S17-34.
4.
Vella, A. Circulator boot therapy alters the natural history
of ischemic limb ulceration. Vascular Medicine 2000; 5: 21-25.
Circulator
Boot Efficacy(pdf)
