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

A

American Association of Sensory Electrodiagnostic Medicine (AASEM)

Status

Active, not recruiting

Conditions

Lower Extremity Swelling Acute

Treatments

Device: Anodyne

Study type

Interventional

Funder types

Industry

Identifiers

NCT01979367
DTSC030113

Details and patient eligibility

About

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.

Full description

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

Enrollment

1,000 estimated patients

Sex

All

Ages

25 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,000 participants in 1 patient group

Anodyne
Experimental group
Description:
To evaluate the efficacy treatment of lower extremity pathologies from neurological ischemia disorders using the Monochromatic Infrared Photo Energy (MIRE)
Treatment:
Device: Anodyne

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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