Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy

Status unconfirmed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Diabetic Polyneuropathy

In brief

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 Diabetic Peripheral Neuropathy (DPN). The study will compare treatment with a NormaTec PCD and a sham device to assess whether the NormaTec PCD improves the signs and symptoms of DPN.

Key facts

Study ID

NCT01175928

Run by

NormaTec Industries LP

People needed

60

Starts

2010-10-01

Expected to finish

2012-09-01

Last updated by the study team

2012-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• NormaTec — Newton Center, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.