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

NCT01979367 | Active Not Recruiting DMC FDA Device

• 1 other identifier: DTSC030113
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lower Extremity Swelling Acute

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Scientific record of treatment success or failure

  5 years

Study Arms (1)

Anodyne

EXPERIMENTAL

To evaluate the efficacy treatment of lower extremity pathologies from neurological ischemia disorders using the Monochromatic Infrared Photo Energy (MIRE)

Device: Anodyne

Interventions

Anodyne DEVICE

Subjects will be treated with MIRE therapy using the Anodyne® device within 72 hours of previous treatments, and in accordance with the Anodyne® package insert indications for use 30 to 45 minutes professional units on power setting of 8,. In addition, patients will undergo TENS therapy with the use of either the Avazzia® Pro Sport or TENS 3000 (for no less than 30 mins, both on label) in accordance with the indications for use of each TENS device, for a minimum of 15 minutes at the subjective site for pain and each vertebrae nerve base, when impairment is confirmed with the objective Small Pain Fiber (SPF) Nerve Conduction Study (NCS) test performed.

Anodyne

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any other excluding factors that, according to the investigator's judgment, would preclude enrollment in the study.

Sponsors & Collaborators

• American Association of Sensory Electrodiagnostic Medicine: lead

Study Officials

• Michael Boyer, M.D.

  American Association of Sensory Electrodiagnostic Medicine

  STUDY DIRECTOR

• Chad Pfefer, M.D.

  American Association of Sensory Electrodiagnostic Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 8, 2013
• Study Start: March 1, 2012
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share