Treatment of Painful Diabetic Neuropathy With Photon Stimulation
Condition: Diabetic Neuropathy, Painful; Diabetic Neuralgia; Diabetic Polyneuropathy; Diabetic Mononeuropathy
MeSH terms: Peripheral Nervous System Diseases; Neuralgia; Diabetic Neuropathies; Polyneuropathies; Mononeuropathies; Pain
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): infrared light; infrared light; placebo
Intervention type(s): Device; Device
Intervention description(s): pulsed infrared light will be applied to feet, ankles and popliteal fossae of patients with diabetic neuropathy; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes mellitus; neuropathy; diabetic neuropathy