Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain

Description

The purpose of this clinical study is to determine the effectiveness of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Company), in providing prescription home use application for temporary relief of diabetic neuropathy foot pain in individuals diagnosed with diabetic neuropathy by a suitably qualified and licensed health professional.

Conditions

Neuropathy, Diabetic, Neuropathy;Peripheral, Neuropathy, Painful

Study Overview

Study Details

Study overview

The purpose of this clinical study is to determine the effectiveness of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Company), in providing prescription home use application for temporary relief of diabetic neuropathy foot pain in individuals diagnosed with diabetic neuropathy by a suitably qualified and licensed health professional.

Clinical Efficacy and Human Factors Validation Testing for Prescription Home Use of the Erchonia Corporation EVRL™ for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain

Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain

Condition
Neuropathy, Diabetic
Intervention / Treatment

-

Contacts and Locations

Phoenix

CiC Foot & Ankle, Phoenix, Arizona, United States, 85028

West Covina

Laser Chiropractic, West Covina, California, United States, 91790

Dunedin

Cesar A. Lara M.D. Weight Loss & Wellness, Dunedin, Florida, United States, 34698

Miramar

FRANCO & CO Podiatric Medicine & Surgery, Miramar, Florida, United States, 33025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Previously diagnosed with diabetes induced peripheral neuropathy by a suitably qualified and licensed health professional within the past 6 months
  • * Over the age of 18 years of age
  • * Able to read and write English.
  • * Constant feet pain on-going over at least the past 3 months.
  • * If using analgesics (pain medication), you must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment; and willing and able to not have planned upward dose titration of analgesics during the study period. You may elect to decrease analgesic use during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context.
  • * Willing and able to refrain from engaging in any non-study procedure therapies for the management of foot pain throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.
  • * Agrees to refrain from taking a dosage of analgesic (pain medication) for at least 6 hours before a scheduled VAS foot pain rating is to be recorded.
  • * Subjects' degree of foot pain on the 0-100 VAS, with "0" being no pain and "100" being worst pain imaginable, is 50 or greater.
  • * Pregnant or think you might be pregnant.
  • * Open wounds (sores, cuts, ulcers, etc) around the feet
  • * Cancerous growths around the feet
  • * Difficulty with hand dexterity sufficient to impact ability to administer treatments with the laser such as from severe arthritis in the hands, Multiple Sclerosis, Cerebral Palsy, Parkinson's Disease, Huntington's Disease, etc.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Erchonia Corporation,

Study Record Dates

2024-12-17