Efficacy of Near Infrared Phototherapy in Type 2 Diabetic Neuropathy

Stopped early · Not applicable · Has a placebo group

Conditions studied: Neuropathy

In brief

This is a double blind, randomized, placebo-controlled study in which a total of 120 patients will be selected from a broad spectrum group of typical Americans (all demographics including various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy. All patients will meet inclusion and/or exclusion criteria.

Key facts

Study ID

NCT02798393

Run by

Healthlight, LLC

People needed

22

Starts

2016-06-01

Expected to finish

2016-10-01

Last updated by the study team

2017-03-01

Who can join

Age: 25 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Type 2 Diabetes Mellitus on oral hypoglycemic medication, and/or injectable insulin
• Hg A1C 5.7 or above ((Pre-Diabetes is 5.7 to 6.4%) (Diabetes is above 6.5%)), Hg A1C below 9.1
• Peripheral Neuropathy of the feet, or feet and legs
• If the patient has a lower extremity ulceration that is not showing any signs of infection, and this patient has ABPI and TBPI above 55 mm of Hg, they may be included in the study, at the discretion of the Principal Investigator (PI). If the patients infection is localized (not osseous in nature) and the infection can be treated and cleared and remain uninfected for 30 days, the patient could be reevaluated and included in the study at the discretion of the PI.
• If the patient has an area of injury or erythema or induration, they may still be included in the study if they have ABPI and TBPI above 55 mm of Hg, at the discretion of the PI
• Positive MNS
• All medications or other treatments for neuropathy are held constant for at least 30 days prior to the study, during the baseline and treatment period of the study.
• Subjects will have pain and insensate sites on each foot (both feet will be assessed and pain scales for both extremities will be measured/followed).
• Moderately positive MNS score.

You may not qualify if…

• Any other causes of Peripheral Neuropathy
• Known Spinal Stenosis
• Previous Back Injury
• Comorbid issues of exacerbated CHF
• Exacerbation of COPD
• Chronic steroid use
• Underlying connective tissue disease
• Previous trauma or underlying fracture
• Current injury or trauma
• Skin ulceration
• ABPI and TBPI measurements will be measured and if the patient has an open ulceration with signs of infection and the wound is weeping any serous or purulent fluid, anywhere on their foot or lower extremity
• Negative MNS
• Previous amputation of a portion of the foot
• Amputation of digit or digits are not considered exclusion criteria
• Previous arterial bypass graft
• Known cardiac arrhythmia
• HG A1C above 9.1%
• Uncontrolled fasting blood sugar, or Type 1 Diabetes.
• If on any anti-epileptic or anti-depressant medications
• If patient has had any change in pain or anti-inflammatory medication anytime within the past 30 days.
• Pregnancy or planned pregnancy (If a patient has begun our research study and does not know that they are pregnant or they become pregnant during the study, they will not be dropped from the study) (Reasoning: there is no evidence for or against using HealthLight therapy in pregnant individuals.)
• Active osteomyelitis or positive for osteomyelitis within the past six months
• Open ulceration with signs and symptoms of active infection.
• Known Peripheral Arterial Disease (PAD)
• Previous Lumbar surgery or Lumbar Disc intervention anytime within the past year

Where it is running

• Midwest Medical Research — Topeka, Kansas, United States

Full record on ClinicalTrials.gov

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