Anodyne Therapy in Diabetic Sensory Neuropathy

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Diabetic Neuropathy

In brief

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.

Key facts

Study ID

NCT00120341

Run by

Scott and White Hospital & Clinic

People needed

60

Starts

2005-04-01

Expected to finish

2006-06-01

Last updated by the study team

2007-06-01

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 extremities.
• 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 the study).
• 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 sarcoidosis.
• Subjects with foot ulcerations.
• Subjects with a transmetatarsal amputation or higher

Where it is running

• Scott and White Santa Fe Center — Temple, Texas, United States

Full record on ClinicalTrials.gov

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