Anodyne Therapy in Diabetic Sensory Neuropathy

May 30, 2007 updated by: Scott and White Hospital & Clinic

A Randomized, Double Blind, Placebo Controlled Prospective Study to Evaluate the Effectiveness of Monochromatic Infrared Photo Energy to Improve 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Temple,, Texas, United States, 76504
        • Scott and White Santa Fe Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
changes in sensation using, vibration perception threshold testing, monofilament testing, and the Michigan Neuropathy Screening Instrument

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scott and White Hospital & Clinic

Collaborators

Anodyne Therapy, LLC

Investigators

  • Principal Investigator: Lawrence A Lavery, DPM, Scott and White Memorial Hospital & Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

July 8, 2005

First Posted (ESTIMATE)

July 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 1, 2007

Last Update Submitted That Met QC Criteria

May 30, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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