Status:
COMPLETED
Anodyne Therapy in Diabetic Sensory Neuropathy
Lead Sponsor:
Scott and White Hospital & Clinic
Collaborating Sponsors:
Anodyne Therapy, LLC
Conditions:
Diabetes Mellitus
Diabetic Neuropathy
Eligibility:
All Genders
25+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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 neur...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00120341
Start Date
April 1 2005
End Date
June 1 2006
Last Update
June 1 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Scott and White Santa Fe Center
Temple, Texas, United States, 76504