Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Mononeuropathy Diabetic Neuralgia Diabetic Neuropathy, Painful Diabetic Polyneuropathy

Keywords

diabetes mellitusneuropathydiabetic neuropathy

Outcome Measures

Primary Outcomes (1)

pain intensity
1 week

Secondary Outcomes (1)

Semmes-Weinstein sensation, proprioception, quality of life
one week

Study Arms (2)

2

ACTIVE COMPARATOR

active treatment with infrared light

Device: infrared light

1

PLACEBO COMPARATOR

sham (placebo) treatment without infrared light

Device: infrared light; placebo

Interventions

infrared lightDevice

pulsed infrared light will be applied to feet, ankles and popliteal fossae of patients with diabetic neuropathy

infrared light; placeboDevice

patients will be exposed to the same machine used to provide pulsed infrared light, but the light emitting diodes will not be activated. All other aspects of the treatment will be the same. The patient and investigator will be blind to treatment assignment.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patients with diabetes mellitus with painful neuropathy, defined as foot pain \>/ 3 on a 0-10 numeric rating scale, chronic foot pain of at least 6 months' duration, and pain characterized as burning, shooting, or stabbing in nature.
Patients needed to have capacity to provide informed consent and be able to make serial visits for scheduled treatments.

Sponsors & Collaborators

East Bay Institute for Research and Education
Otherlead

Study Sites (1)

VA Northern California Health Care System

Martinez, California, 94553, United States

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

Arthur LM Swislocki, MD
VA Northern California Health Care System; UC Davis School of Medicine
PRINCIPAL INVESTIGATOR

Enrollment

120 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 4, 2007

Study Start

October 2004

Date type not reported

This date has not been verified as actual or estimated.

Treatment of Painful Diabetic Neuropathy With Photon Stimulation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

2

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

2

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations