Trial Outcomes & Findings for Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain (NCT NCT05091047)

Results Overview

The Numerical Rating Scale (NRS) assesses the level or degree of pain. With '0: no pain at all' and '100: worst pain imaginable. The subject will be asked to rate the level of foot pain he or she is experiencing at that time.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

Baseline and 3 week

Results posted on

2022-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia EVRL 635 nanometers (nm) and 405 nm laser application Erchonia EVRL: 42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia EVRL n=8 Participants 635 nanometers (nm) and 405 nm laser application Erchonia EVRL: 42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks.
Age, Categorical <=18 years	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=8 Participants
Age, Categorical >=65 years	3 Participants n=8 Participants
Sex: Female, Male Female	5 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=8 Participants
Duration of Feet Pain	6.5 years n=8 Participants

PRIMARY outcome

Timeframe: Baseline and 3 week

The Numerical Rating Scale (NRS) assesses the level or degree of pain. With '0: no pain at all' and '100: worst pain imaginable. The subject will be asked to rate the level of foot pain he or she is experiencing at that time.

Outcome measures

Outcome measures
Measure	Erchonia EVRL n=8 Participants 635 nanometers (nm) and 405 nm laser application Erchonia EVRL: 42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks.
Change in Pain Numerical Rating Scale (NRS)	43.75 units on a scale Standard Deviation 20.98

Adverse Events

Erchonia EVRL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Affairs Manager

Erchonia Corporation

Phone: 888.242.0571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place