The purpose of this research study is to determine if the use of a series of the Anodyne
Therapy System in-home treatments over a 90-day period will improve peripheral sensation and
quality of life in persons with diabetes mellitus.
The morbidity, direct cost and mortality associated with lower extremity complications among
patients with diabetes mellitus have been well described in the medical literature.
Peripheral sensory neuropathy is one of the strongest risk factors for both foot ulceration
and amputation in this population. In the absence of neuropathy people rarely develop foot
ulcers. Because of the lack of painful feedback, peripheral neuropathy provides a permissive
environment that allows repetitive tissue injury to occur such that a person may wear a hole
in the bottom of his or her foot much in the way that he or she may wear a hole in a
stocking. Certainly, the early detection of a level of peripheral neuropathy sufficient to
contribute to the development of foot wounds or “loss of protective sensation” is one of the
most important criteria to identify high risk patients for foot complications and is
paramount when instituting a structured treatment plan to prevent lower extremity
The objective of the study is to determine the efficacy of the application of a series of
Anodyne in-home treatments over a 90-day period to improve peripheral sensation and
self-reported quality of life in persons with diabetes mellitus. This pilot study should
provide preliminary data to determine if additional clinical evaluation is warranted and to
determine an appropriate sample size. The hypothesis is the Anodyne therapy will improve
sensory function over the course of therapy compared to sham therapy.
- Subjects with diabetes mellitus and peripheral sensory neuropathy.
- Subjects at least 25 years old.
- Vibration perception threshold (VPT) ≥ 20 volts and ≤ 45 volts.
- Subjects must be alert, oriented, mentally competent and able to understand and
comply with the requirements of the study, and provide voluntary informed consent.
- Subjects must be willing and able to complete the required study visits and record
treatment activity in the study logbook.
- Subjects who have a VPT <20 or > 45 volts.
- Subjects with uncontrolled hypertension greater than 180 systolic or greater than 110
diastolic as determined by enrollment questionnaire
- Subjects who are pregnant or breastfeeding or who are likely to become pregnant
during the course of the study.
- Subjects with active malignancy (including basal cell carcinoma) on the lower
- Subjects who have had prior reconstructive or replacement knee surgery with
neurological deficits related to the surgery. ( If the patient has had knee surgery,
their neuropathy appears to be uniform and bilateral, then they can be included in
- Subjects with a history of previous back surgery, spinal stenosis, or spinal
compression or radiculopathy with neurological deficits related to spinal cord
pathology. ( If the patient has had back surgery, their neuropathy appears to be
uniform and bilateral, then they can be included in the study).
- Subjects who are non-ambulatory.
- Subjects with a history of neuromuscular disease, leprosy, chronic alcoholism, or
- Subjects with foot ulcerations.
- Subjects with a transmetatarsal amputation or higher
Temple,, Texas 76504
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