NCT00120341

CompletedPhase 4

Anodyne Therapy in Diabetic Sensory Neuropathy

Scott and White Hospital & Clinic Source

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Other study identifiers

Sponsor study identifier

50100

Study Type

interventional

Reported enrollment (type unavailable)

60

Locations

1 country

Sites

1

Timeline

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

June 2006

Date type not reported

This date has not been verified as actual or estimated.

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 persons with diabetes mellitus.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: June 2006
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 30, 2005
Actual (reported)
First Posted
July 15, 2005
Actual (reported)
Study Completion
June 2006
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: June 1, 2007
Status Verified: May 2007
Last Update Submitted: May 30, 2007

Conditions

Diabetes Mellitus Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

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

Interventions

Anodyne Therapy SystemDevice

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age25 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects with diabetes mellitus and peripheral sensory neuropathy.
Subjects at least 25 years old.

Sponsors & Collaborators

Scott and White Hospital & Clinic
Otherlead
Anodyne Therapy, LLC
Industrycollaborator

Study Sites (1)

Scott and White Santa Fe Center

Temple, Texas, 76504, United States

Related Publications (1)

Lavery LA, Murdoch DP, Williams J, Lavery DC. Does anodyne light therapy improve peripheral neuropathy in diabetes? A double-blind, sham-controlled, randomized trial to evaluate monochromatic infrared photoenergy. Diabetes Care. 2008 Feb;31(2):316-21. doi: 10.2337/dc07-1794. Epub 2007 Oct 31.
PMID: 17977931DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetic Neuropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes Complications

Study Officials

Lawrence A Lavery, DPM
Scott and White Memorial Hospital & Clinic
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: FACTORIAL
Sponsor Type: OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 15, 2005

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

June 2006

Date type not reported

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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

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

June 1, 2007

Record last verified: 2007-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00120341
Data provider: ClinicalTrials.gov
Source updated: 2007-06-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:14 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations