Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling



Status:Enrolling by invitation
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:25 - 90
Updated:3/16/2019
Start Date:March 2012
End Date:March 2021

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To Evaluate the Efficacy Treatment of Lower Extremity Pathologies Derived From Neurological Ischemia Disorders

Physician Clinical Trial Policy (CTP) to evaluate the efficacy treatment of lower extremity
pathologies derived from neurological ischemia disorders using the combination of
Monochromatic Infrared Photo Energy (MIRE) and Transcutaneous Electrical Nerve Stimulation
(TENS) therapies.

Although there are a number of pain disorders, associated with back, or lower extremity pain
and swelling, the American Association of Sensory Electrodiagnostic Medicine (AASEM/ DTSC)
study programs will accumulate received data following a protocol of treatment performed for
the purpose of eliminating pain, reducing swelling, and accelerating recovery periods as well
as to record the success or failure and/or improvement of the malfunctioning body part.

- Condition: Neuropathic Pain, Tingling or Numbness derived from neurological Ischemia

- Intervention: Treatments of Monochromatic Infrared Photo Energy (MIRE) in combination
with Electronic Signal Treatment (TENS) therapy

- Study Type: Interventional

- Study Design:

1. Allocation: Non-Randomized

2. Endpoint Classification: Efficacy Study

3. Intervention Model: Single Group Assignment

4. Masking: Open Label

5. Primary Purpose: Scientific record of treatment success or failure

Inclusion Criteria:

- In the investigator's judgment, a high probability of 5 year survival and compliance
with the study visit schedule.

Ability to comprehend and sign an informed consent document prior to study enrollment.

Exclusion Criteria:

- Any other excluding factors that, according to the investigator's judgment, would
preclude enrollment in the study.
We found this trial at
4
sites
2645 Nall Street
Port Neches, Texas 77651
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Port Neches, TX
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3901 Liberty Street
Erie, Pennsylvania 16509
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Erie, PA
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Louisville, Kentucky 40241
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Louisville, KY
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Silsbee, Texas 77656
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from
Silsbee, TX
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