Clinical trial NCT01175928: Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy
Official title: Phase 2 Study of the NormaTec PCD in the Treatment of Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Polyneuropathy
Keywords: Diabetic polyneuropathy
Pneumatic Compression Device
Lead sponsor: NormaTec Industries LP
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 common causes for hospital admissions and lower-limb amputations among diabetic patients. However, to date there are no medications currently approved by the Food and Drug Administration to treat DPN.

The goal of this research project is to assess the effectiveness of a non-invasive, patented peristaltic pulse pneumatic compression device (the NormaTec PCD) in a home treatment program to improve the symptoms of DPN (e.g. numbness, pain, and tingling in the legs) and the underlying functioning of the nerves in the legs (as determined by sensory perception assessments and Nerve Conduction Studies testing).

In this prospective, randomized, double-blind study, subjects will be randomly placed in one of two groups: a control group using a sham NormaTec PCD ("placebo"); and an experimental group using a NormaTec PCD.

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

Primary outcomes:
measure: Nerve Conduction Studies
timeFrame: 3 months
measure: Nerve Conduction Studies
timeFrame: 1 month
measure: Nerve Conduction Studies
timeFrame: 2 months
Secondary outcomes:
measure: Sensory perception measurements
timeFrame: baseline; 1 month; 2 months; 3 months
measure: Quality of life questionnaires
timeFrame: baseline; 1 month; 2 months; 3 months
Other outcomes:
Locations:
city: Newton Center
country: United States
facility: NormaTec
state: Massachusetts
Study officials:
affiliation: Saints Medical Center
name: Nicholas Spirito, MD
role: PRINCIPAL_INVESTIGATOR
References: