BACKGROUND:
There is no therapy for peripheral neuropathy
(PN) which occurs in more than 50% of long-term
diabetics. PN is the primary cause of diabetic
ulcers and the most predictive diagnosis for
an eventual amputation. As part of the therapeutic
approach to post operative incisions and disease
induced wounds experienced by diabetic patients,
physical therapists at TMCA and DHMC routinely
use a medical device, the Anodyne Therapy
System (ATS). The ATS is FDA cleared for pain
reduction and improving circulation. It emits
monochromatic, near infrared photo energy
(MIRE) from a series of 60 diodes in a flexible
array that is placed in contact with the skin.
Occasionally, diabetic patients report improvement
in sensory perception in the feet although
feet were not directly exposed to MIRE.
PURPOSE:
We instituted a prospective study of 49 diabetics
(Type I, n=25; Type II, n=24) each of whom
received treatment with the ATS to determine
if there was an improvement of sensation.
METHODS:
At baseline, all patients had absent or impaired
protective sensation as measured by the Semmes-Weinstein
(SW) monofilament test (range 4.56-6.45).
42 of 49 patients had clinically-determined
SW values exceeding 5.07, reported to be the
single most predictive diagnosis of diabetic
foot ulceration. The ATS diode array was placed
in contact with the skin on the lower leg/foot
for 30 min./day, 3X/week for one month and
SW tests were repeated at two and four weeks.
RESULTS:
After two weeks, 48/49 patients exhibited
improved sensation. After 12 treatments, all
49 patients had improved sensation and 65%
of the patients demonstrated a restoration
of protective sensation (SW at 4.17 or below).
No patient had a SW value above 4.93.
CONCLUSION:
The ATS may be a safe, non-invasive therapy
for the consistent and predictable improvement
of foot sensation in diabetic patients with
PN.
