Temporary relief of foot pain from diabetic neuropathy using a laser device
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
This study tests whether a laser device can help people with diabetic neuropathy find temporary relief from foot pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erchonia Corporation Industry-sponsored |
| Locations | 4 sites (Phoenix, Arizona and 3 other locations) |
| Trial ID | NCT05291975 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the effectiveness of the Erchonia® EVRL™ device in providing temporary relief for foot pain caused by diabetic peripheral neuropathy. The study will first conduct human factors validation testing to ensure that users can safely and effectively operate the device. Following this, a double-blind, randomized, placebo-controlled phase will assess the device's efficacy in a home-use setting for individuals diagnosed with diabetic neuropathy. Participants will be required to meet specific eligibility criteria, including stable pain management regimens.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been diagnosed with diabetes-induced peripheral neuropathy within the last six months and experience ongoing foot pain.
Not a fit: Patients who do not have a diagnosis of diabetic peripheral neuropathy or those who are not willing to refrain from other pain management therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new, non-invasive treatment option for patients suffering from diabetic neuropathy foot pain.
How similar studies have performed: While similar approaches have been explored, the specific use of the Erchonia® EVRL™ device for this purpose is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 3 other locations
- CiC Foot & Ankle — Phoenix, Arizona, United States (Completed)
- Laser Chiropractic — West Covina, California, United States (Recruiting)
- Cesar A. Lara M.D. Weight Loss & Wellness — Dunedin, Florida, United States (Completed)
- FRANCO & CO Podiatric Medicine & Surgery — Miramar, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.