Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT02798393
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Type 2 Diabetes Mellitus on oral hypoglycemic medication, and/or injectable insulin
2. Hg A1C 5.7 or above ((Pre-Diabetes is 5.7 to 6.4%) (Diabetes is above 6.5%)), Hg A1C below 9.1
3. Peripheral Neuropathy of the feet, or feet and legs
4. 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.
5. 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
6. Positive MNS
7. 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.
8. 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).
9. Moderately positive MNS score.
Exclusion Criteria:
1. Any other causes of Peripheral Neuropathy
2. Known Spinal Stenosis
3. Previous Back Injury
4. Comorbid issues of exacerbated CHF
5. Exacerbation of COPD
6. Chronic steroid use
7. Underlying connective tissue disease
8. Previous trauma or underlying fracture
9. Current injury or trauma
10. Skin ulceration
11. 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
12. Negative MNS
13. Previous amputation of a portion of the foot
14. Amputation of digit or digits are not considered exclusion criteria
15. Previous arterial bypass graft
16. Known cardiac arrhythmia
17. HG A1C above 9.1%
18. Uncontrolled fasting blood sugar, or Type 1 Diabetes.
19. If on any anti-epileptic or anti-depressant medications
20. If patient has had any change in pain or anti-inflammatory medication anytime within the past 30 days.
21. 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.)
22. Active osteomyelitis or positive for osteomyelitis within the past six months
23. Open ulceration with signs and symptoms of active infection.
24. Known Peripheral Arterial Disease (PAD)
25. Previous Lumbar surgery or Lumbar Disc intervention anytime within the past year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
90 Years
Study:
NCT02798393
Study Brief:
Protocol Section:
NCT02798393