Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy

Exclusion Criteria

• •Refuses consent
• •Unlikely to be compliant with the research protocol as judged by the clinical investigator
• •Neuropathy documented to be caused by something other than diabetes
• •Medication for neuropathic pain initiated within the previous 3 months (to avoid confounding the results of the study)
• •Medication for glucose control changed within the previous 3 months (to avoid confounding the results of the study)
• •Documented DVT within the previous 3 months (since an acute DVT is a contraindication for Pneumatic Medicine treatment)
• •Significant hepatic disease as judged by the clinical investigator (that might cause neuropathy unrelated to diabetes)
• •Documented cancer treatment within the past 5 years (that might cause neuropathy unrelated to diabetes)
• •History of exposure to neurotoxins or heavy metals (that might cause neuropathy unrelated to diabetes)
• •Documented alcohol or drug abuse (that might cause neuropathy unrelated to diabetes)
• •Documented major psychiatric disorder (that could contribute to non-adherence to the protocol)
• •Presence of a major lower extremity amputation (since unable to perform bilateral distal sensory perception testing of the feet and NCS on the peroneal motor nerve)
• •Significant peripheral arterial disease defined as an ankle-brachial index ("ABI") \< 0.6 (to avoid critical limb ischemia and thus the high likelihood of the patient requiring a major amputation in the near future with drop out from the study)
• •Severe lower extremity edema as judged by the clinical investigator (in order to not confound the results)
• •End stage DPN where the peroneal motor nerve conduction results of both legs show an Amplitude = 0 mV
• •Currently participating in another clinical trial