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Treatment of Painful Diabetic Neuropathy With Photon Stimulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539175
First Posted: October 4, 2007
Last Update Posted: October 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
East Bay Institute for Research and Education
  Purpose

1. Objectives:

  1. To assess the efficacy of Photon Stimulation compared with placebo, in treating the pain of diabetic neuropathy.
  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.

2. Research Design

This is a double blinded, randomized, placebo-controlled study of 120 patients with painful diabetic neuropathy. These 120 will be randomly assigned treatments utilizing Photon Therapy, using a defined treatment protocol. We expect that some patients will drop out, and our goal is 100 treated patients, for statistical purposes. The Photon Therapy group will be split into two groups, one group that receives Active Photon Therapy and one group that will be treated with the same type of equipment that has been modified to emit no infrared photons (Non Active Photon Therapy Group ("Placebo")). The patients in the "Non Active Photon Therapy Group" will be offered an Active Photon Treatment Session after completion of the study. The patients in the Photon Therapy Groups will be randomized. There will also be an Historical Control Group of patients, fifty, will have received traditional medical interventions (e.g., narcotics, seizure medications) in traditional medical practices. Data from these individuals will be used to calculate potential cost savings.

3. Methodology:

Subjects who meet the inclusion and exclusion criteria and have signed a valid informed consent will be eligible to participate in the study. After screening, subjects in the Photon Therapy groups (both active and nonactive) will undergo four treatment sessions. The first treatment session will vary from the second, third and fourth. During all treatment session, each patient will be imaged with the TIP Infrared Camera before, and after treatment. Infrared imaging can visualize skin temperature changes in a noninvasive manner (2). The first treatment will utilize slightly different protocol than subsequent visits, reduced Photon dosage, 120 instead of 240 joules. Proprioception and protective sensation, characterized by the Semmes-Weinstein monofilament test, and visual and analog pain scoring will also be evaluated before and after each Photon Therapy treatment.

4. Finding:

To date, we have just completed 120 patients, using a block randomization scheme not previously reported in this field. We have collected data on nerve function, pain, quality of life, and skin circulation. The data will remain stored until the study is complete to preserve the blinded nature of the project. Data analysis is still incomplete.

4. Clinical Significance

Diabetic neuropathy is a chronic and progressive condition that potentially leads to disabling pain, and worse, amputation, for many individuals in the United States each year. Present treatments utilize antiseizure medications, opiate analgesics, and antidepressants, and are inconsistently effective. Development of a new treatment strategy potentially could have significant benefit for a great many patients.


Condition Intervention
Diabetic Neuropathy, Painful Diabetic Neuralgia Diabetic Polyneuropathy Diabetic Mononeuropathy Device: infrared light Device: infrared light; placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Painful Diabetic Neuropathy With Photon Stimulation

Resource links provided by NLM:


Further study details as provided by East Bay Institute for Research and Education:

Primary Outcome Measures:
  • pain intensity [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Semmes-Weinstein sensation, proprioception, quality of life [ Time Frame: one week ]

Enrollment: 120
Study Start Date: October 2004
Study Completion Date: October 2006
Arms Assigned Interventions
Active Comparator: 2
active treatment with infrared light
Device: infrared light
pulsed infrared light will be applied to feet, ankles and popliteal fossae of patients with diabetic neuropathy
Placebo Comparator: 1
sham (placebo) treatment without infrared light
Device: infrared light; placebo
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.

  Hide Detailed Description

Detailed Description:

• PURPOSE, METHODS, AND PROCEDURES:

1. Purpose:

  1. To assess the efficacy of Photon Stimulation compared with placebo, in treating the pain of diabetic neuropathy.
  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.

2. Methods

This is a double blinded, randomized, placebo-controlled study of approximately 170 patients with painful diabetic neuropathy. The study sample size is 170 patients. Of these 120 will be given treatments utilizing Photon Therapy, using a defined treatment protocol. We plan to recruit 120 patients to allow for drop out, and to provide 100 completed patients, as requested by FDA. The Photon Therapy group will be split into two groups, one group that receives Active Photon Therapy and one group that will be treated with the same type of equipment that has been modified to emit no infrared photons (Non Active Photon Therapy Group ("Placebo")). The patients in the "Non Active Photon Therapy Group" will be offered an Active Photon Treatment Session after completion of the study. The patients in the Photon Therapy Groups will be randomized. The Historical Control Group of patients, fifty, will have received traditional medical interventions (e.g., narcotics, seizure medications) in traditional medical practices.

3. Procedures: Subjects who meet the inclusion and exclusion criteria and have signed a valid informed consent will be eligible to participate in the study. After screening, subjects in the Photon Therapy groups (both active and nonactive) will undergo four treatment sessions. The first treatment session will vary from the second, third and fourth. During all treatment session, each patient will be imaged with the TIP Infrared Camera before, and after treatment. Infrared imaging can visualize skin temperature changes in a noninvasive manner (2). The first treatment will utilize slightly different protocol than subsequent visits, reduced Photon dosage, 120 instead of 240 joules. Proprioception and protective sensation, characterized by the Semmes-Weinstein monofilament test, and visual and analog pain scoring will also be evaluated before and after each Photon Therapy treatment.

  • SUBJECT SELECTION: Subjects were initially recruited from the PI's clinic, from a list of patients diagnosed by Dr. Beckley (Electromyographer) with painful diabetic neuropathy, and from local referrals. In October 2004, we received permission to post flyers and solicit patients (identified by Dr Beckley) from primary providers (flyer and letter attached). We also recruited by posting flyers in VANCHCS facilities, and with VANCHCS diabetes educators. Word of mouth also provided many subjects. In September 2006 we modified the flyer to reflect a focused recruitment at Mather. Vulnerable populations will not be studied.
  • RISKS: The potential risks to subjects include physical, psychological, social and economic. These are not likely: The physical risks include discomfort from the photon machine. The psychological risks include boredom. The social risks include being labeled as having a chronic illness, and the risk of loss of privacy. The economic risk includes time off from work that may be needed to participate in the treatment program. Confidentiality will be maintained as much as possible, by storing paper data in locked offices, without name identifiers, and electronic data on spreadsheets on password-protected computers in locked offices.
  • BENEFITS: Individual subjects may derive benefit via pain relief; this would also obtain to the whole group of patients with painful diabetic neuropathy.
  • RISK-BENEFIT RATIO: The risk is minimal, and the benefit minimal to moderate (potentially greater).
  • SAFETY MONITORING: Research staff will monitor for safety.
  • INFORMED CONSENT PROCEDURES: The PI (Dr. Swislocki) and his staff (Ms. Orth, Ms. Weisshaupt) will conduct, obtain, and document informed consent within VANCHCS facilities.
  • PRIVACY AND CONFIDENTIALITY PROTECTIONS: Confidentiality will be maintained as much as possible, by storing paper data in locked offices, without name identifiers, and electronic data on spreadsheets on password-protected computers in locked offices.
  • COSTS TO SUBJECTS: No added expenses are expected. No compensation is proposed.
  • DISCLOSURE OF PERSONAL AND FINANCIAL INTEREST IN THE RESEARCH STUDY AND SPONSOR: The Principal Investigator has no personal or financial interests in the research or personal or financial interest in the entity.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539175


Locations
United States, California
VA Northern California Health Care System
Martinez, California, United States, 94553
Sponsors and Collaborators
East Bay Institute for Research and Education
Investigators
Principal Investigator: Arthur LM Swislocki, MD VA Northern California Health Care System; UC Davis School of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00539175     History of Changes
Other Study ID Numbers: Swislocki-1
First Submitted: October 2, 2007
First Posted: October 4, 2007
Last Update Posted: October 4, 2007
Last Verified: October 2007

Keywords provided by East Bay Institute for Research and Education:
diabetes mellitus
neuropathy
diabetic neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Pain
Neuralgia
Polyneuropathies
Mononeuropathies
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases