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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT01175928
Eligibility Criteria:
Inclusion Criteria:
* Patient diagnosed with type 1 or type 2 diabetes
* Patient diagnosed with distal symmetric polyneuropathy (DPN) attributable to diabetes
* A1C ≤ 11%
* Abnormal peroneal motor nerve conduction study where CMAP amplitude is less than 4 mV bilaterally.
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01175928
Study Brief:
Protocol Section:
NCT01175928