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NCT00539175 · ClinicalTrials.gov registry record · NA
Treatment of Painful Diabetic Neuropathy With Photon Stimulation
A NA study, sponsored by East Bay Institute for Research and Education.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT00539175 is a NA study that has completed, run by East Bay Institute for Research and Education. The registered enrollment target is 120 participants.
The verdict
NCT00539175, a NA study, has completed, sponsored by East Bay Institute for Research and Education.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study 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 th
Interventions
- DEVICE infrared light
- DEVICE infrared light; placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2004-10 |
| Est. Completion | 2006-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00539175
The ClinicalTrials.gov registry entry for NCT00539175 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is East Bay Institute for Research and Education, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which infrared light is the first listed.
NCT00539175 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00539175 about?
NCT00539175 is a clinical study titled "Treatment of Painful Diabetic Neuropathy With Photon Stimulation". 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 ...
What is the current status of trial NCT00539175?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2004-10. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00539175?
The interventions under investigation include: infrared light (DEVICE), infrared light; placebo (DEVICE).
Who is sponsoring clinical trial NCT00539175?
This trial is sponsored by East Bay Institute for Research and Education, which has 5 total clinical trials registered on ClinicalTrials.gov.
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