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

• ClinicalTrials.gov Identifier: NCT01882725
• Recruitment Status: Completed
• First Posted: June 20, 2013
• Results First Posted: July 14, 2015
• Last Update Posted: July 14, 2015
• Sponsor: Erchonia Corporation
• Information provided by (Responsible Party): Erchonia Corporation

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Defective; Circulation
• Intervention: Device: Erchonia HP Scanner (HPS)
• Enrollment: 14

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Erchonia HP Scanner (HPS)
Arm/Group Description	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.
Period Title: Overall Study
Started	14
Completed	14
Not Completed	0

Baseline Characteristics

Arm/Group Title		Erchonia HP Scanner (HPS)
Arm/Group Description		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 Number of Baseline Participants		14
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	14 participants
		51.79 (11.31)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants
	Female	12 85.7%
	Male	2 14.3%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants
	Hispanic or Latino	1 7.1%
	Not Hispanic or Latino	13 92.9%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	14 participants
		14
Duration of Heel Pain [1]; Mean (Standard Deviation); Unit of measure: Months
	Number Analyzed	14 participants
		15.93 (15.52)
		[1] Measure Description: Duration of heel pain is recorded as number of months of chronic heel pain experienced prior to study enrollment
Degree of Heel Pain on the Visual Analog Scale (VAS) [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	14 participants
		69.29 (10.67)
		[1] Measure Description: The Visual Analog Pain Scale (VAS) is one of the three most commonly used scales for assessing chronic pain consisting of a 100 millimeter (mm) horizontal line anchored at one end by the label "0: no pain at all" and at the other end "100: worst pain imaginable". The subject marks on the line the spot for the overall degree of pain experienced in the study treated heel region upon waking in the morning and taking the first few steps of the day, which is then measured using a ruler.

Outcome Measures

1. Primary Outcome

Title	Change in Skin Perfusion Pressure (SPP)
Description	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.
Time Frame	baseline and 3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erchonia HP Scanner (HPS)
Arm/Group Description:	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 Number of Participants Analyzed	14
Mean (Standard Deviation); Unit of Measure: percentage of change
	17.68 (30.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erchonia HP Scanner (HPS)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]

2. Secondary Outcome

Title	Change in Skin Surface Temperature on the Hind Foot
Description	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.
Time Frame	baseline and 3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erchonia HP Scanner (HPS)
Arm/Group Description:	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 Number of Participants Analyzed	14
Mean (Standard Deviation); Unit of Measure: Degrees Farenheit
	2.93 (3.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erchonia HP Scanner (HPS)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.01
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	3 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Erchonia HP Scanner (HPS)
Arm/Group Description	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.
All-Cause Mortality
	Erchonia HP Scanner (HPS)
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Erchonia HP Scanner (HPS)
	Affected / at Risk (%)
Total	0/14 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Erchonia HP Scanner (HPS)
	Affected / at Risk (%)
Total	0/14 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Kerry Zang, DPM
• Organization: Arizona Institute of Footcare Physicians
• Phone: 480-834-8804
• EMail: kerryzang@aol.com

• Responsible Party: Erchonia Corporation
• ClinicalTrials.gov Identifier: NCT01882725
• Other Study ID Numbers: EC_HPBC_001_ZANG
• First Submitted: June 17, 2013
• First Posted: June 20, 2013
• Results First Submitted: April 4, 2014
• Results First Posted: July 14, 2015
• Last Update Posted: July 14, 2015