An interventional study of Erchonia HP Scanner (HPS) in Defective; Circulation, sponsored by Erchonia Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-14.
Sponsored by Erchonia Corporation · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether low level laser light therapy is effective in increasing local blood circulation in people with chronic heel pain arising from plantar fasciitis.
Healthy blood circulation is important to overall health and well-being, as strong and steady local blood flow delivers fresh nutrients to the cells and prevents accumulation of waste materials within the cells necessary to maintain healthy cell function. Conversely, poor local blood circulation can cause numerous acute and chronic health problems, and can manifest itself in symptoms of pain, numbness, weakness and swelling, and can exacerbate these symptoms in co-existing acute and chronic conditions. Chronic conditions that may result from poor blood circulation that is untreated and persists over a long period of time include varicose veins, kidney damage, stroke and heart attack. Memory loss, frequent headaches, dizzy spells and slowed mental response can also result.
Therefore, improving local blood circulation has significant positive implications for both the overall health and well-being of an individual and for improving, relieving and preventing symptoms and long-term complications of poor blood circulation. Treatment to improve blood circulation include simple options such as changes in dietary and exercise habits, and alternative treatments such as acupuncture and herbal remedies. Medications may be prescribed to assist with contributory conditions such as high blood pressure or cholesterol. In more progressed cases, surgical options such as angioplasty or bypass may be performed to treat narrowed or blocked arteries.
However, less invasive options are usually minimally effective, medication has its own risks and side-effects and surgical procedures are invasive and carry significant procedural risks and potential complications. The purpose of this study is to evaluate the efficacy of low level laser therapy as a means of increasing local blood circulation as it is related to reducing chronic heel pain arising from plantar fasciitis that is simple, non-invasive and risk-free.
Low level laser therapy is believed to effect various physiological mechanisms of change that include improved blood flow and increased cell metabolism, advanced healing, anti-inflammatory actions and stimulation of the immune system. The laser directs light energy into the body's cells. The cells then convert this light energy into chemical energy to promote natural healing and pain relief. The laser also allows photons to enter the tissue and become absorbed in the cells mitochondria within which the photonic energy is converted to electromagnetic energy in the form of adenosine triphosphate (ATP). This additional ATP is energy the cell uses to trigger positive physiological responses from the body such as increased cell metabolism and development of muscle tissue and collagen, improvement of blood circulation, stimulation of tissue repair, wound healing and stimulation of the nervous and immune systems.
Erchonia Corporation is the lead sponsor of 48 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
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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.
Device: 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)
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
Change in Skin Surface Temperature on the Hind Foot
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
| Milestone | Erchonia HP Scanner (HPS) |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
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.
| percentage of change | Erchonia HP Scanner (HPS) |
|---|---|
| Change in Skin Perfusion Pressure (SPP) | 17.68 ± 30.37 |
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.
| Degrees Farenheit | Erchonia HP Scanner (HPS) |
|---|---|
| Change in Skin Surface Temperature on the Hind Foot | 2.93 ± 3.55 |
Collected over 3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erchonia HP Scanner (HPS) | — | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Erchonia HP Scanner (HPS) |
|---|---|
| Mean | 51.79 ± 11.31 |
| Sex: Female, Male(Participants) | Erchonia HP Scanner (HPS) |
|---|---|
| Female | 12 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Erchonia HP Scanner (HPS) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Erchonia HP Scanner (HPS) |
|---|---|
| United States | 14 |
| Duration of Heel Pain(months) | Erchonia HP Scanner (HPS) |
|---|---|
| Mean | 15.93 ± 15.52 |
| Degree of Heel Pain on the Visual Analog Scale (VAS)(units on a scale) | Erchonia HP Scanner (HPS) |
|---|---|
| Mean | 69.29 ± 10.67 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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