Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by NormaTec Industries LP.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
NormaTec Industries LP
ClinicalTrials.gov Identifier:
NCT01175928
First received: August 3, 2010
Last updated: April 18, 2012
Last verified: April 2012

August 3, 2010
April 18, 2012
October 2010
September 2012   (final data collection date for primary outcome measure)
  • Nerve Conduction Studies [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
  • Nerve Conduction Studies [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
  • Nerve Conduction Studies [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).
Same as current
Complete list of historical versions of study NCT01175928 on ClinicalTrials.gov Archive Site
  • Sensory perception measurements [ Time Frame: baseline; 1 month; 2 months; 3 months ] [ Designated as safety issue: No ]
    Non-invasive sensory perception will be assessed with a 10-g monofilament (pressure); a 128 Hz tuning fork and a Neurothesiometer (vibration); a toothpick (sharp sensation); a cotton ball (soft sensation); an iced tuning fork (cold sensation); and calculation of the Neuropathy Disability Score.
  • Quality of life questionnaires [ Time Frame: baseline; 1 month; 2 months; 3 months ] [ Designated as safety issue: No ]
    The following questionnaires will be self-administered: Norfolk Quality-of-Life Questionnaire for Diabetic Neuropathy (QOL-DN); Neuropathy Total Symptom Score-6 (NTSS-6); Problem Areas in Diabetes (PAID)
Same as current
Not Provided
Not Provided
 
Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy
Phase 2 Study of the NormaTec PCD in the Treatment of Diabetic Peripheral Neuropathy

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Polyneuropathy
  • Device: Sham device
    Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day
    Other Name: NormaTec PCD (sham device)
  • Device: NormaTec PCD (Peristaltic Pulse PCD)
    Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day
    Other Name: NormaTec PCD
  • Experimental: Peristaltic Pulse PCD
    Peristaltic Pulse Pneumatic Compression Device (NormaTec PCD)
    Intervention: Device: NormaTec PCD (Peristaltic Pulse PCD)
  • Sham Comparator: Sham Device
    Sham Pneumatic Compression Device (looks and sounds like real device, but applies no compression)
    Intervention: Device: Sham device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01175928
NormaTec_90513134-01, 1R43DK088634-01
No
NormaTec Industries LP
NormaTec Industries LP
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Nicholas Spirito, MD Saints Medical Center
NormaTec Industries LP
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP