Status:
UNKNOWN
Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy
Lead Sponsor:
NormaTec Industries LP
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Polyneuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of the NormaTec PCD, a non-invasive pneumatic compression device with the patented peristaltic pulse pneumatic waveform, in the treatment of Diabe...
Detailed Description
Diabetes frequently leads to decreased sensation in the legs caused by diabetic peripheral neuropathy (DPN). DPN is an important risk factor for the development of foot ulceration, one of the most com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01175928
Start Date
October 1 2010
End Date
September 1 2012
Last Update
April 20 2012
Active Locations (1)
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1
NormaTec
Newton Center, Massachusetts, United States, 02459