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Laser Therapy
Low-Level Laser Therapy for Diabetic Foot Pain
N/A
Recruiting
Research Sponsored by Erchonia Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 weeks
Awards & highlights
Study Summary
This trial will test whether the Erchonia EVRL machine can provide relief from foot pain caused by diabetic neuropathy.
Who is the study for?
Adults over 18 with diabetic neuropathy who've had constant foot pain for at least 3 months can join. They must be on a stable pain medication routine without changes planned during the study and not use other pain therapies. Pregnant individuals, those with open wounds or cancerous growths on their feet, or severe hand dexterity issues due to conditions like MS are excluded.Check my eligibility
What is being tested?
The trial is testing the Erchonia EVRL laser's effectiveness in providing temporary relief of foot pain caused by diabetic neuropathy against a placebo laser. Participants will use these treatments at home as prescribed and report their levels of foot pain.See study design
What are the potential side effects?
Since this trial involves a low-level laser therapy device, side effects may include mild skin irritation at the treatment site. However, significant side effects are not commonly associated with such non-invasive treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Secondary outcome measures
Neuropathic Pain Symptom Inventory (NPSI)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Erchonia® EVRL™Active Control1 Intervention
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.
Group II: Placebo LaserPlacebo Group1 Intervention
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.
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Who is running the clinical trial?
Erchonia CorporationLead Sponsor
43 Previous Clinical Trials
1,935 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My foot pain level is 50 or higher on a scale of 0-100.I agree not to use other foot pain treatments during the study.You must be able to read and write English.I have been on a steady pain medication plan for at least 2 weeks with no changes expected.I agree not to take painkillers 6 hours before my foot pain rating.My pain medication dose has been stable for the last 14 days and I won't increase it during the study.I am over 18 years old.I have had constant pain in my feet for at least 3 months.I am over 18 years old.I have open wounds on my feet.I have had constant foot pain for the last 3 months.I have cancerous growths near my feet.I was diagnosed with nerve damage from diabetes by a doctor in the last 6 months.I have trouble using my hands due to a condition like severe arthritis or Parkinson's.I agree not to use other treatments for foot pain during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Erchonia® EVRL™
- Group 2: Placebo Laser
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of participants for this trial?
"Affirmative. Clinicaltrials.gov attests that this research, which was initially proposed on February 17th 2022, is actively looking for participants. A total of 64 individuals must be recruited from 3 distinct medical sites."
Answered by AI
Does enrollment in this project remain open to interested participants?
"Indeed, the clinical trial is looking for new participants. Initially posted on February 17th 2022 and freshly updated on August 1st 2022, 64 volunteers are needed from 3 medical centers to take part in this study."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
CiC Foot & Ankle
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
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