Diabetic Peripheral NeuropathyPhase 2NCT02328911
Laser Therapy for Diabetic Peripheral Neuropathic Pain
A Phase 2 study testing Laser treatment in people with Diabetic Peripheral Neuropathy, run by University of Miami at 1 site in United States.
Trial summary
The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy of a course of laser therapy on peripheral neuropathic pain in persons with diabetes. The hypothesis is that laser therapy will produce significant improvement on measures of self-reported pain among adults with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Is age 18 or older
- Has diabetes
- Has chronic, unresolved neuropathic pain of the feet for more than 3 months
- able to attend the treatment schedule on-campus for the period of the intervention
- Is willing to provide informed consent to participate in study
Who cannot join
- Has any chronic open wounds on your back or bottom of the feet
- Is pregnant
- Diagnosed with schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, or alcohol or substance abuse/dependence
- Diagnosed with a bleeding disorder
- Diagnosed with aphasia or sensory, motor, or visual disturbances that could interfere with assessments
- Diagnosed with any major pulmonary, renal, thyroid, hepatic, gastrointestinal, or seizure conditions
Show all 14Show fewer
- Had any hematologic or ontological disorders treated with chemotherapy in the previous two years
- Is currently undergoing any chemotherapy or radiation treatment for cancer
- Has had more than three major medical or psychiatric hospitalizations in the past year
- Has been diagnosed with a terminal illness
- Is you currently participating in another trial with drugs, dietary supplements, or medical treatment that affects neuropathic pain
- Is currently taking any opioid or other pain medication
- Is currently taking any pain-relieving nutritional supplement, herb, antioxidants or integrative medicine for diabetic neuropathy
- Is currently taking prescription or over-the-counter pain relievers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry & Behavioral Sciences
Miami, Florida, 33136
About this study
Official title: Laser Therapy Treatment of Peripheral Neuropathic Pain in Individuals With Diabetes
The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy of a course of laser therapy on peripheral neuropathic pain in persons with diabetes. The hypothesis is that laser therapy will produce significant improvement on measures of self-reported pain among adults with diabetes.
Read the detailed description
The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy of a course of laser therapy on peripheral neuropathic pain in persons with diabetes. Participants will be assessed at baseline, post-intervention, and 3-months followup, and the study will consist of two treatment arms, including: (a) twice-per-week laser treatment for 4 weeks and once-per-week laser treatment for 8 weeks or (b) same treatment schedule sham (or placebo) for 12 weeks. Additionally, the study will examine inflammatory markers, functional status, and quality of life.
Specific Aim 1. Change from baseline in self-reported pain in a sample of adults with diabetes at their last visit and at 3 months. Hypothesis 1: The laser therapy will produce significant improvement at post-intervention and three-month followup on measures of self-reported pain among adults with diabetes. Specific Aim 2: Decrease biochemical markers of inflammation by investigating levels of cytokines. Hypothesis 2: The laser therapy will produce significant improvement at post-intervention and three-month followup on levels of inflammatory markers.Specific Aim 3: Improve quality of life. Hypothesis 3: The laser therapy will produce significant improvement at post-intervention and three-month followup on quality of life.No substantial psychological, medical, or social risks exist to the participants, other than minor discomfort associated with the venipuncture.
Although all measures to protect confidentiality will be put in place, the possibility exists that electronic data could be jeopardized. In the remote case that such event occurs, it will be immediately reported to the IRB.The proper use of the LiteCure LightForce FX Therapy Laser class IV laser therapy device should be harmless and presents no different risks than similar laser therapy devices currently on the market. At the time of this submission, no serious adverse events have been reported to the company or the regulatory authority by consumers. All study personnel will complete detailed training in the use of the device and will follow the directions of the manufacturer for operating the device; all instructions for use of the device will be followed for each subject.
As reported by LiteCure Medical the LiteCure LightForce FX therapy laser device has been cleared by the FDA, tested according IEC electrical safety standards for medical devices, and manufactured in an ISO13485 compliant facility. These certifications ensure that LiteCure Medical devices are manufactured in state of the art facilities, under strict quality control, and environmental protection standards. Participants will incur no additional appreciable psychological or social risks by participating in this study. The process of interviewing during the assessment may cause discomfort. Discomfort or fatigue may also be experienced in completing the assessment battery.
The information obtained in this study will help in determining the efficacy of using a class IV laser therapy device for neuropathic pain, inflammation, and quality of life in persons with diabetic distal symmetric peripheral neuropathy. By participating in the study, subjects may feel less pain, have lower inflammation, and experience improved quality of life. The minimal risk of participating in this study is reasonable because of the potential benefit gained in pain status, inflammatory status, and quality of life.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Laser treatment, Sham treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentDevice
Also called LiteCure™ LCT-1000 laser
Laser energy will be applied to the skin of the back and feet manually by physician though a device with a movable head, in contact with the skin, that emits therapeutic dual-wavelength infrared laser energy as well as red visible light.
Sham treatmentDevice
Also called LiteCure™ LCT-1000 laser with laser device disabled
A sham treatment will be applied to the skin of the back and feet manually by physician though a device with a movable head, in contact with the skin, that emits only red visible light.
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Twice-per-week laser treatment for 4 weeks and once-per-week laser treatment for 8 weeks. Inflammatory markers, functional status, and quality of life will be examined. Receives: Device: Laser treatment |
| Sham treatment | Sham comparator | Twice-per-week sham treatment for 4 weeks and once-per-week sham treatment for 8 weeks. Inflammatory markers, functional status, and quality of life will be examined. Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported pain.
Pain will be quantitatively assessed through the use of the vibration testing technique (on-off method) and the Semmes-Weinstein monofilament test .The assessment will be carried out at baseline, baseline up to 12 weeks (weekly), and at 3 months follow-up. In addition, changes in pain over the course of the study will be assessed with several questionnaires and tests, including the Visual Analogue Scale Quadruple Pain Scale, (VAS-QPS), the Neuropathic Pain Scale (NPS), and the Pain Disability Questionnaire (PDQ).
Measured: Baseline, from baseline up to 12 weeks (weekly) , and 3-month follow-up.
Secondary outcomes (2)
Change in inflammation by measuring levels of biochemical markers.
Subjects will have blood drawn, and the tests will include a cytokine panel to check for inflammation in the body at baseline, baseline up to 12 weeks (weekly), and at 3 months follow-up.
Measured: Baseline, from baseline up to 12 weeks (weekly) , and 3-month follow-up.
Change in quality of life.
Subjects will be asked to complete the Medical Outcomes Study Short Form 36 (SF-36) in order to assess the subjects' functional status and measure general health-related quality of life at baseline, baseline up to 12 weeks (weekly), and at 3 months follow-up.
Measured: Baseline, from baseline up to 12 weeks (weekly) , and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Difficulty recruiting qualified subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- LiteCure LLC
- Responsible party
- Principal investigator, John E. Lewis, University of Miami
- Investigators
- John E. Lewis, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328911
- Sponsor's protocol ID
- 20110921
- Status last verified
- Sep 2015
- First submitted
- 16 Nov 2014
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Alster TS, Bryan H, Williams CM. Long-pulsed Nd:YAG laser-assisted hair removal in pigmented skin: a clinical and histological evaluation. Arch Dermatol. 2001 Jul;137(7):885-9.
PubMed 11453807Hegedus B, Viharos L, Gervain M, Galfi M. The effect of low-level laser in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial. Photomed Laser Surg. 2009 Aug;27(4):577-84. doi: 10.1089/pho.2008.2297.
PubMed 19530911Kaviani A, Djavid GE, Ataie-Fashtami L, Fateh M, Ghodsi M, Salami M, Zand N, Kashef N, Larijani B. A randomized clinical trial on the effect of low-level laser therapy on chronic diabetic foot wound healing: a preliminary report. Photomed Laser Surg. 2011 Feb;29(2):109-14. doi: 10.1089/pho.2009.2680. Epub 2011 Jan 9.
PubMed 21214368Meireles SM, Jones A, Jennings F, Suda AL, Parizotto NA, Natour J. Assessment of the effectiveness of low-level laser therapy on the hands of patients with rheumatoid arthritis: a randomized double-blind controlled trial. Clin Rheumatol. 2010 May;29(5):501-9. doi: 10.1007/s10067-009-1347-0. Epub 2010 Jan 16.
PubMed 20082104Montes-Molina R, Madronero-Agreda MA, Romojaro-Rodriguez AB, Gallego-Mendez V, Prados-Cabiedas C, Marques-Lucas C, Perez-Ferreiro M, Martinez-Ruiz F. Efficacy of interferential low-level laser therapy using two independent sources in the treatment of knee pain. Photomed Laser Surg. 2009 Jun;27(3):467-71. doi: 10.1089/pho.2008.2315.
PubMed 19405858Moritz AR. Studies of Thermal Injury: III. The Pathology and Pathogenesis of Cutaneous Burns. An Experimental Study. Am J Pathol. 1947 Nov;23(6):915-41. No abstract available.
PubMed 19970971Naeser MA. Photobiomodulation of pain in carpal tunnel syndrome: review of seven laser therapy studies. Photomed Laser Surg. 2006 Apr;24(2):101-10. doi: 10.1089/pho.2006.24.101.
PubMed 16706688
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Therapy Treatment of Peripheral Neuropathic Pain in Individuals With Diabetes
- ClinicalTrials.gov ID
- NCT02328911
- Acronym / sponsor ID
- 20110921
- Conditions
- Diabetic Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting qualified subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- LiteCure LLC
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy of a course of laser therapy on peripheral neuropathic pain in persons with diabetes. The hypothesis is that laser therapy will produce significant improvement on measures of self-reported pain among adults with diabetes.
Detailed description
The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy of a course of laser therapy on peripheral neuropathic pain in persons with diabetes. Participants will be assessed at baseline, post-intervention, and 3-months followup, and the study will consist of two treatment arms, including: (a) twice-per-week laser treatment for 4 weeks and once-per-week laser treatment for 8 weeks or (b) same treatment schedule sham (or placebo) for 12 weeks. Additionally, the study will examine inflammatory markers, functional status, and quality of life.
Specific Aim 1. Change from baseline in self-reported pain in a sample of adults with diabetes at their last visit and at 3 months. Hypothesis 1: The laser therapy will produce significant improvement at post-intervention and three-month followup on measures of self-reported pain among adults with diabetes. Specific Aim 2: Decrease biochemical markers of inflammation by investigating levels of cytokines. Hypothesis 2: The laser therapy will produce significant improvement at post-intervention and three-month followup on levels of inflammatory markers.Specific Aim 3: Improve quality of life. Hypothesis 3: The laser therapy will produce significant improvement at post-intervention and three-month followup on quality of life.No substantial psychological, medical, or social risks exist to the participants, other than minor discomfort associated with the venipuncture.
Although all measures to protect confidentiality will be put in place, the possibility exists that electronic data could be jeopardized. In the remote case that such event occurs, it will be immediately reported to the IRB.The proper use of the LiteCure LightForce FX Therapy Laser class IV laser therapy device should be harmless and presents no different risks than similar laser therapy devices currently on the market. At the time of this submission, no serious adverse events have been reported to the company or the regulatory authority by consumers. All study personnel will complete detailed training in the use of the device and will follow the directions of the manufacturer for operating the device; all instructions for use of the device will be followed for each subject.
As reported by LiteCure Medical the LiteCure LightForce FX therapy laser device has been cleared by the FDA, tested according IEC electrical safety standards for medical devices, and manufactured in an ISO13485 compliant facility. These certifications ensure that LiteCure Medical devices are manufactured in state of the art facilities, under strict quality control, and environmental protection standards. Participants will incur no additional appreciable psychological or social risks by participating in this study. The process of interviewing during the assessment may cause discomfort. Discomfort or fatigue may also be experienced in completing the assessment battery.
The information obtained in this study will help in determining the efficacy of using a class IV laser therapy device for neuropathic pain, inflammation, and quality of life in persons with diabetic distal symmetric peripheral neuropathy. By participating in the study, subjects may feel less pain, have lower inflammation, and experience improved quality of life. The minimal risk of participating in this study is reasonable because of the potential benefit gained in pain status, inflammatory status, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Device: Laser treatmentTwice-per-week laser treatment for 4 weeks and once-per-week laser treatment for 8 weeks. Inflammatory markers, functional status, and quality of life will be examined. |
| Sham treatment | Sham comparator | Device: Sham treatmentTwice-per-week sham treatment for 4 weeks and once-per-week sham treatment for 8 weeks. Inflammatory markers, functional status, and quality of life will be examined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is age 18 or older
- Has diabetes
- Has chronic, unresolved neuropathic pain of the feet for more than 3 months
- able to attend the treatment schedule on-campus for the period of the intervention
- Is willing to provide informed consent to participate in study
Key exclusion criteria (14 listed)
- Has any chronic open wounds on your back or bottom of the feet
- Is pregnant
- Diagnosed with schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, or alcohol or substance abuse/dependence
- Diagnosed with a bleeding disorder
- Diagnosed with aphasia or sensory, motor, or visual disturbances that could interfere with assessments
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 |
|---|---|---|
| Laser treatmentAlso: LiteCure™ LCT-1000 laserLaser energy will be applied to the skin of the back and feet manually by physician though a device with a movable head, in contact with the skin, that emits therapeutic dual-wavelength infrared laser energy as well as red visible light. | Device | Laser treatment |
| Sham treatmentAlso: LiteCure™ LCT-1000 laser with laser device disabledA sham treatment will be applied to the skin of the back and feet manually by physician though a device with a movable head, in contact with the skin, that emits only red visible light. | Device | Sham treatment |
Primary outcome
Change in self-reported pain.
Time frame: Baseline, from baseline up to 12 weeks (weekly) , and 3-month follow-up.
Pain will be quantitatively assessed through the use of the vibration testing technique (on-off method) and the Semmes-Weinstein monofilament test .The assessment will be carried out at baseline, baseline up to 12 weeks (weekly), and at 3 months follow-up. In addition, changes in pain over the course of the study will be assessed with several questionnaires and tests, including the Visual Analogue Scale Quadruple Pain Scale, (VAS-QPS), the Neuropathic Pain Scale (NPS), and the Pain Disability Questionnaire (PDQ).
2 secondary outcomes
Change in inflammation by measuring levels of biochemical markers.
Time frame: Baseline, from baseline up to 12 weeks (weekly) , and 3-month follow-up.
Change in quality of life.
Time frame: Baseline, from baseline up to 12 weeks (weekly) , and 3-month follow-up.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Background: PubMed 11453807Alster TS, Bryan H, Williams CM. Long-pulsed Nd:YAG laser-assisted hair removal in pigmented skin: a clinical and histological evaluation. Arch Dermatol. 2001 Jul;137(7):885-9.
- Background: PubMed 19530911Hegedus B, Viharos L, Gervain M, Galfi M. The effect of low-level laser in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial. Photomed Laser Surg. 2009 Aug;27(4):577-84. doi: 10.1089/pho.2008.2297.
- Background: PubMed 21214368Kaviani A, Djavid GE, Ataie-Fashtami L, Fateh M, Ghodsi M, Salami M, Zand N, Kashef N, Larijani B. A randomized clinical trial on the effect of low-level laser therapy on chronic diabetic foot wound healing: a preliminary report. Photomed Laser Surg. 2011 Feb;29(2):109-14. doi: 10.1089/pho.2009.2680. Epub 2011 Jan 9.
- Background: PubMed 20082104Meireles SM, Jones A, Jennings F, Suda AL, Parizotto NA, Natour J. Assessment of the effectiveness of low-level laser therapy on the hands of patients with rheumatoid arthritis: a randomized double-blind controlled trial. Clin Rheumatol. 2010 May;29(5):501-9. doi: 10.1007/s10067-009-1347-0. Epub 2010 Jan 16.
- Background: PubMed 19405858Montes-Molina R, Madronero-Agreda MA, Romojaro-Rodriguez AB, Gallego-Mendez V, Prados-Cabiedas C, Marques-Lucas C, Perez-Ferreiro M, Martinez-Ruiz F. Efficacy of interferential low-level laser therapy using two independent sources in the treatment of knee pain. Photomed Laser Surg. 2009 Jun;27(3):467-71. doi: 10.1089/pho.2008.2315.
- Background: PubMed 19970971Moritz AR. Studies of Thermal Injury: III. The Pathology and Pathogenesis of Cutaneous Burns. An Experimental Study. Am J Pathol. 1947 Nov;23(6):915-41. No abstract available.
- Background: PubMed 16706688Naeser MA. Photobiomodulation of pain in carpal tunnel syndrome: review of seven laser therapy studies. Photomed Laser Surg. 2006 Apr;24(2):101-10. doi: 10.1089/pho.2006.24.101.
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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.
John E. Lewis, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laser treatment in people with Diabetic Peripheral Neuropathy, run by University of Miami 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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 28 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 self-reported pain. (time frame: Baseline, from baseline up to 12 weeks (weekly) , and 3-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02328911, which also lists 7 linked publications.
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 28 Sep 2015.