Treatment of Painful Diabetic Neuropathy With Photon Stimulation

NCT00539175 | Completed

• 1 other identifier: Swislocki-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1\. Objectives:

1. 1.To assess the efficacy of Photon Stimulation compared with placebo, in treating the pain of diabetic neuropathy.
2. 2.To show that Photonic Stimulation for the treatment of painful diabetic neuropathy is cost effective compared to traditional medical interventions. The latter will be explored by an extensive search of the literature and from an equal number of patients being treated in traditional medical practices using traditional medical interventions. At the conclusion of the study the data will be analyzed for cost-benefits and the possibility of crafting a best-practices approach to treat these syndromes that cost billions of dollars a year in health care expenses and lost productivity.

Conditions

Diabetic Neuropathy, Painful; Diabetic Neuralgia; Diabetic Polyneuropathy; Diabetic Mononeuropathy

Keywords

diabetes mellitus; neuropathy; diabetic 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 light DEVICE

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

2

infrared light; placebo DEVICE

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.

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

You may not qualify if:

• A history of peripheral vascular disease
• Vitamin B12 deficiency
• Low back pain with radiculopathy; Or
• Another painful condition that was difficult to distinguish from painful diabetic peripheral neuropathy.

Sponsors & Collaborators

• East Bay Institute for Research and Education: lead

Study Sites (1)

VA Northern California Health Care System

Martinez, California, 94553, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Arthur LM Swislocki, MD

  VA Northern California Health Care System; UC Davis School of Medicine

  PRINCIPAL INVESTIGATOR

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 1, 2004
• Study Completion: October 1, 2006
• Last Updated: October 4, 2007

Record last verified: 2007-10

Locations

US (1)