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

Primary Purpose

Neuropathy, Diabetic, Neuropathy;Peripheral, Neuropathy, Painful

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia® EVRL™
Placebo Laser
Sponsored by
Erchonia Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathy, Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • CiC Foot & AnkleRecruiting
  • FRANCO & CO Podiatric Medicine & SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Erchonia® EVRL™

Placebo Laser

Arm Description

The Erchonia® EVRL™ is made up of (1) 635 nanometers red laser diode and (1) 405 nanometers violet laser diode mounted in a portable handheld device.

The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.

Outcomes

Primary Outcome Measures

Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) from baseline to endpoint (6 weeks) measurement is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome. For the primary study outcome, the overall study success is defined as a 35% or greater difference between the proportion (number) of individual successes in each treatment group.

Secondary Outcome Measures

Neuropathic Pain Symptom Inventory (NPSI)
The NPSI is a 12-item self-administered patient-reported outcome (PRO) assessment tool with a recall/ observation period of over the past 24 hours. It contains 10 descriptors representing 5 distinct dimensions on the basis of factor analysis: burning pain, deep pain, paroxysmal pain, evoked pain, paresthesia/dysesthesia, and 2 temporal items designed to assess pain duration and the number of pain paroxysms. The NPSI has been validated in patients with definite neuropathic pain of peripheral or central origin.

Full Information

First Posted
March 14, 2022
Last Updated
March 28, 2023
Sponsor
Erchonia Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05291975
Brief Title
Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
December 17, 2023 (Anticipated)
Study Completion Date
December 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Human Factors Validation Testing will initially be conducted to valuate a lay person's ability to understand and apply as applicable the information contained in the EVRL™ Use Device Proper Use Reference Guide, and device packaging and labeling materials to correctly, safely, and successfully activate and operate the EVRL™ to administer the treatment; and to identify any and all use difficulties, problems and errors, including those pertaining to critical tasks and close calls demonstrated by the lay person during device operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification, as applicable Phase Two will commence following the successful completion of Phase One. Phase Two comprises the performance of a double-blind, randomized, placebo-controlled, clinical study of the efficacy of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Sponsor), for prescription home use application in providing temporary relief of diabetic peripheral neuropathy foot pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy, Diabetic, Neuropathy;Peripheral, Neuropathy, Painful

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erchonia® EVRL™
Arm Type
Active Comparator
Arm Description
The Erchonia® EVRL™ is made up of (1) 635 nanometers red laser diode and (1) 405 nanometers violet laser diode mounted in a portable handheld device.
Arm Title
Placebo Laser
Arm Type
Placebo Comparator
Arm Description
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.
Intervention Type
Device
Intervention Name(s)
Erchonia® EVRL™
Intervention Description
The Erchonia® EVRL™ is made up of (1) 635 nanometers red laser diode and (1) 405 nanometers violet laser diode mounted in a portable handheld device. The diodes are positioned approximately 3 to 6 inches from the top of the foot. The treatments will be self-administered by the subject at his or her's place of residence, two times per day for 21 days. Each procedure administration lasts 5 minutes per foot, for a total of 10 minutes.
Intervention Type
Device
Intervention Name(s)
Placebo Laser
Intervention Description
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light. The diodes are positioned approximately 3 to 6 inches from the top of the foot. The treatments will be self-administered by the subject at his or her's place of residence, two times per day for 21 days. Each procedure administration lasts 5 minutes per foot, for a total of 10 minutes.
Primary Outcome Measure Information:
Title
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Description
The Visual Analog Scale (VAS) from baseline to endpoint (6 weeks) measurement is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome. For the primary study outcome, the overall study success is defined as a 35% or greater difference between the proportion (number) of individual successes in each treatment group.
Time Frame
Baseline and 3 weeks
Secondary Outcome Measure Information:
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
The NPSI is a 12-item self-administered patient-reported outcome (PRO) assessment tool with a recall/ observation period of over the past 24 hours. It contains 10 descriptors representing 5 distinct dimensions on the basis of factor analysis: burning pain, deep pain, paroxysmal pain, evoked pain, paresthesia/dysesthesia, and 2 temporal items designed to assess pain duration and the number of pain paroxysms. The NPSI has been validated in patients with definite neuropathic pain of peripheral or central origin.
Time Frame
Baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
CiC Foot & Ankle
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Zang, DPM
Phone
602-954-0777
Email
kerryzang@aol.com
Facility Name
FRANCO & CO Podiatric Medicine & Surgery
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Franco
Phone
954-436-7400
Email
jmfranco@francoandcompany.com
First Name & Middle Initial & Last Name & Degree
Sandra Franco, DPM

12. IPD Sharing Statement

Plan to Share IPD
No

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

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