Trial Outcomes & Findings for Study of Low Level Laser Light Therapy to Improve Blood Circulation in People With Chronic Heel Pain (NCT NCT01882725)

Last Updated: 2015-07-14

Results Overview

Skin Perfusion Pressure (SPP) measured peripheral microcirculation or skin perfusion using a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia, the transient increase in blood flow that occurs following a brief period of ischemia. The SPP value was measured in mmHg. The per cent (%) change in mean Skin Perfusion Pressure (SPP) in mmHg was calculated as the % change in measurements from before the first procedure administration with the Erchonia® HPS Laser to after the sixth and final procedure administration. It was pre-determined that a minimum mean change in % SPP of +10% or greater across the evaluation period would be considered clinically meaningful. A positive (+) change indicates that SPP increased across the procedure administration phase and is positive for study efficacy. A negative (-) change indicates that SPP decreased across the procedure administration phase and is negative for study efficacy.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

baseline and 3 weeks

Results posted on

2015-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia HP Scanner (HPS) The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light. Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Low Level Laser Light Therapy to Improve Blood Circulation in People With Chronic Heel Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia HP Scanner (HPS) n=14 Participants The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light. Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
Age, Continuous	51.79 years STANDARD_DEVIATION 11.31 • n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	14 participants n=99 Participants
Duration of Heel Pain	15.93 months STANDARD_DEVIATION 15.52 • n=99 Participants
Degree of Heel Pain on the Visual Analog Scale (VAS)	69.29 units on a scale STANDARD_DEVIATION 10.67 • n=99 Participants

PRIMARY outcome

Timeframe: baseline and 3 weeks

Outcome measures

Outcome measures
Measure	Erchonia HP Scanner (HPS) n=14 Participants The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light. Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
Change in Skin Perfusion Pressure (SPP)	17.68 percentage of change Standard Deviation 30.37

SECONDARY outcome

Timeframe: baseline and 3 weeks

Skin surface temperature on the hind foot was recorded in degrees using an infrared thermometer. Change in skin surface temperature in degrees was calculated as the change in measurements before the first procedure administration (baseline) to after the sixth and final procedure administration. It was pre-determined that a minimum mean increase in skin surface temperature of +2.5 degrees across the procedure administration phase would be considered clinically meaningful. A positive (+) change indicates that the skin surface temperature increased across the procedure administration phase and is positive for study efficacy. A negative (-) change indicates that the skin surface temperature decreased across the procedure administration phase and is negative for study efficacy.

Outcome measures

Outcome measures
Measure	Erchonia HP Scanner (HPS) n=14 Participants The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light. Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
Change in Skin Surface Temperature on the Hind Foot	2.93 Degrees Farenheit Standard Deviation 3.55

Adverse Events

Erchonia HP Scanner (HPS)

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

Kerry Zang, DPM

Arizona Institute of Footcare Physicians

Phone: 480-834-8804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place