COMPLETED

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

Conditions

Neuropathy, Diabetic Neuropathy;Peripheral Neuropathy, Painful

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-02-17

Study Completion:2024-12-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05291975

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

CiC Foot & Ankle

Phoenix, Arizona, 85028

United States

Laser Chiropractic

West Covina, California, 91790

United States

Cesar A. Lara M.D. Weight Loss & Wellness

Dunedin, Florida, 34698

United States

FRANCO & CO Podiatric Medicine & Surgery

Miramar, Florida, 33025

United States

Collaborators and Investigators

Sponsor: Erchonia Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-17

Study Completion Date2024-12-12

Study Record Updates

Study Start Date2022-02-17

Study Completion Date2024-12-12

Terms related to this study

Additional Relevant MeSH Terms

Neuropathy, Diabetic
Neuropathy;Peripheral
Neuropathy, Painful