Defective; CirculationNCT01882725
Study of Low Level Laser Light Therapy to Improve Blood Circulation in People With Chronic Heel Pain
A study testing Erchonia HP Scanner (HPS) in people with Defective; Circulation, run by Erchonia Corporation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Defective; Circulation
- What is being tested?
- Erchonia HP Scanner (HPS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral Mechanical Plantar Heel Pain: insertional heel pain of the plantar fascia - plantar fasciitis - in one heel
- Chronic heel pain defined as at least 3 months of ongoing heel pain with no evidence of acute trauma to the heel
- A self-rating on the 0-100 Visual Analog Scale of at least 50 for heel pain experienced upon taking the first few steps of the study qualification evaluation day (recorded retrospectively), to be confirmed by the two-day average VAS attained during the Baseline Washout phase.
- Heel pain has been previously unresponsive to prescription non-steroidal anti-inflammatory drugs (NSAIDs) taken over a minimum period of 2 weeks; and any two or more of the following conservative treatments: rest, taping, stretching, orthotics, shoe modifications, night splinting, casting, physical therapy, or local corticosteroid injections.
- Subject is willing and able to refrain from consuming over-the-counter and/or prescription medications for the indication of the relief of pain throughout the study.
- Subject is willing and able to refrain from partaking in other non-study treatments or therapies for the relief of heel pain throughout the study.
Who cannot join
- Subject does not have any one or more of the following etiologies of chronic heel pain: Mechanical Posterior Heel Pain; Neurologic Heel Pain; Arthritic Heel Pain; and Traumatic Heel Pain
- Evidence of acute trauma to the heel
- Loss of plantar foot sensation
- Foot deformity
- Previous surgery to the heel
- Foot trauma within the previous three months
Show all 30Show fewer
- Skin ulceration - infection or wound - on the heel and surrounding treatment area
- Sciatica
- Benign and malignant tumors
- Acute infection of soft tissue/bone, e.g. osteomyelitis
- Presence of diabetic neuropathic pain
- Diabetes Type I
- Presence of sensory neuropathy
- Previous diagnosis of neuropathy affecting lower extremities
- Peripheral vascular disease or autoimmune disease
- Fibromyalgia
- Chronic fatigue syndrome
- Chronic pain disorders
- Metabolic disorders: Osteomalacia, Paget's disease, Sickle cell disease
- Blood coagulation disorders
- Significant heart conditions including Congestive Heart Failure (CHF) and implantable heart devices
- Non-ambulatory status
- Unable or unwilling to consume the study rescue medication of Tylenol
- Photosensitivity disorder
- Pregnant or lactating
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the consent form and ability to record the necessary measurements.
- History of drug or alcohol abuse
- Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to the study condition
- Participation in any type of research in the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Institute of Footcare Physicians
Mesa, Arizona, 85204
About this study
Official title: An Evaluation of the Effect of the Erchonia HP Scanner (HPS) Laser on Increasing Blood Circulation in Individuals With Chronic Heel Pain
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.
Read the detailed description
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.
- Conditions
- Defective; Circulation
- Being tested
- Erchonia HP Scanner (HPS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia HP Scanner (HPS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia HP Scanner (HPS) | Experimental | 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. Receives: Device: Erchonia HP Scanner (HPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3 weeks
Secondary outcomes (1)
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.
Measured: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Defective; CirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerry Zang, DPM, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882725
- Sponsor's protocol ID
- EC_HPBC_001_ZANG
- Status last verified
- Jul 2015
- First submitted
- 17 Jun 2013
- Last updated
- 14 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of the Erchonia HP Scanner (HPS) Laser on Increasing Blood Circulation in Individuals With Chronic Heel Pain
- ClinicalTrials.gov ID
- NCT01882725
- Acronym / sponsor ID
- EC_HPBC_001_ZANG
- Conditions
- Defective; Circulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Posted 14 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erchonia HP Scanner (HPS) | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral Mechanical Plantar Heel Pain: insertional heel pain of the plantar fascia - plantar fasciitis - in one heel
- Chronic heel pain defined as at least 3 months of ongoing heel pain with no evidence of acute trauma to the heel
- A self-rating on the 0-100 Visual Analog Scale of at least 50 for heel pain experienced upon taking the first few steps of the study qualification evaluation day (recorded retrospectively), to be confirmed by the two-day average VAS attained during the Baseline Washout phase.
- Heel pain has been previously unresponsive to prescription non-steroidal anti-inflammatory drugs (NSAIDs) taken over a minimum period of 2 weeks; and any two or more of the following conservative treatments: rest, taping, stretching, orthotics, shoe modifications, night splinting, casting, physical therapy, or local corticosteroid injections.
- Subject is willing and able to refrain from consuming over-the-counter and/or prescription medications for the indication of the relief of pain throughout the study.
Key exclusion criteria (30 listed)
- Subject does not have any one or more of the following etiologies of chronic heel pain: Mechanical Posterior Heel Pain; Neurologic Heel Pain; Arthritic Heel Pain; and Traumatic Heel Pain
- Evidence of acute trauma to the heel
- Loss of plantar foot sensation
- Foot deformity
- Previous surgery to the heel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Erchonia HP Scanner (HPS) |
Primary outcome
Change in Skin Perfusion Pressure (SPP)
Time frame: baseline and 3 weeks
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.
1 secondary outcome
Change in Skin Surface Temperature on the Hind Foot
Time frame: baseline and 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry Zang, DPM principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia HP Scanner (HPS) in people with Defective; Circulation, run by Erchonia Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Perfusion Pressure (SPP) (time frame: baseline and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.