Mary Lu W. (RN, CDE)
Milwaukee, Wisconsin 
Case Background

As a Certified Diabetes educator, I am well aware of diabetic peripheral neuropathy (DPN), the nerve damage associated with diabetes.  As the recent Decision Memorandum CAG-00059, issued by the Centers for Medicare and Medicaid Services points out, DPN with loss of protective sensation is “the most important factor leading to amputation in people with diabetes” and ”most consistently noted as a significant risk factor for lower extremity events including amputations, ulcers and other lesions”.  Also, DPN may impair balance,  limit ambulation and increase the risk of falls.  DPN has been thought to be progressive and irreversible.  The only therapeutic intervention has been tight glucose control to delay the onset of DPN and minimize the level of impairment.  However, since many patients with Type II diabetes are not diagnosed until many years after the onset of their diabetes, DPN has already begun by the time of initial diagnosis. 

A recent clinical study, published in the March 2002 Journal of the American Podiatric Medical Association, reports restoration of protective sensation using a non-invasive, near infrared photo energy system known as the Anodyne Therapy System.  Based on this clinical data, my endocrinologist and I instituted the Anodyne Therapy to determine whether my loss of protective sensation due to DPN could be restored.   

Diagnosis

I have had Type 1 diabetes for 35 years and have DPN.  My DPN, as determined by insensitivity to a 5.07 Semmes Weinstein Monofilament at 5 positions on the bottom of the feet, has been diagnosed for 5 years.  I use an insulin pump and my glucose levels have averaged between 130 and 160 for the past 5 years.  I have no prior history of foot ulcers since I meticulously care for my feet.  However, I do have documented numbness, pain, and loss of hot and cold response in my feet. 

Therapeutic Intervention

Anodyne Therapy was initiated on October 2, 2001.  The treatment protocol consisted of placing one Anodyne Therapy pad longitudinally on the bottom and top of each foot for a period of 30-45 minutes per day one time per day.  Treatments were self-administered at home.

Results

After 2 weeks of treatment, I subjectively noted increased feeling in both feet. After 9 weeks (conclusion of the therapeutic intervention), I was retested using the Semmes Weinstein test, and sensitivity to a 5.07 monofilament was noted in all 5 locations on both feet.  Accordingly, restoration of protective sensation was clinically established.  Additionally, more discreet sensory testing was conducted using other sized monofilaments and my sensitivity ranged from 3.61 to 4.17, which was within the high normal sensory levels commonly reported by individuals without peripheral neuropathy.  From a quality of life standpoint, I found that for the first time in 5 years, I was able to feel a pair of socks and my toes against my shoes and warm feet.  No adverse effects were experienced either objectively or subjectively. 

Conclusion

Daily self-administration of Anodyne therapy for 30-45 minutes per day over a period of 9 weeks was shown to clinically restore protective sensation, which had been lost for 5 years as a result of DPN.  

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