Anodyne Therapy in Diabetic Sensory Neuropathy
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.
Device: Anodyne Therapy System
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind, Placebo Controlled Prospective Study to Evaluate the Effectiveness of Monochromatic Infrared Photo Energy to Improve Diabetic Sensory Neuropathy|
- changes in sensation using, vibration perception threshold testing, monofilament testing, and the Michigan Neuropathy Screening Instrument
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||June 2006|
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 complications.
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.
|United States, Texas|
|Scott and White Santa Fe Center|
|Temple,, Texas, United States, 76504|
|Principal Investigator:||Lawrence A Lavery, DPM||Scott and White Memorial Hospital & Clinic|