Heat Shock Therapy to Improve Mitochondrial Function in Neuropathy

Exclusion Criteria

• •1. skin conditions, circulatory insufficiency, or open wounds in the leg that would interfere with healing from a biopsy;
• •2. stroke or other significant nervous system pathology;
• •3. lidocaine allergy;
• •4. anticipated difficulty with blood clotting due to disorder or use of a blood thinner such as Coumadin, Xarelto, or Eliquis;
• •5. use of any medication used to treat abnormal blood glucose such as Metformin;
• •6. body weight \> 350 lbs.;
• •7. history of anemia or vitamin b12 deficiency;
• •8. clinical anemia (hematocrit \<32 for women, \<36 for men);
• •9. abnormal SPEP result;
• •10. history of cancer or chemotherapy treatment;
• •11. current or recent use (within the last 6 months) of artificial fingernails / nail enhancements that would interfere with quantitative sensory testing;
• •12. no special classes of subjects such as fetuses, neonates, pregnant women, prisoners, institutionalized individuals, non-English speaking individuals, or other who may be considered vulnerable populations will be included in this study.
• •Withdrawal/Termination criteria: Prediabetes will be determined using the American Diabetes Association (ADA) Diabetes Management Guidelines. The subject will meet the criteria for a diagnosis of pre-diabetes if the subject has one or more positive test(s) for either A1c (5.7-6.4%), fasting glucose (100-125 mg/dl), or 2-hr oral glucose tolerance test (140-199 mg/dl). If at pre-intervention evaluation, the subject does not meet the criteria for prediabetes (lower than the above-mentioned range), meets the ADA criteria for diabetes (higher than the above-mentioned range), the subject will be considered a screen fail and will not progress to skin biopsy or intervention.