Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy - Full Text View

Sponsor:	NormaTec Industries LP
Collaborator:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):	NormaTec Industries LP
ClinicalTrials.gov Identifier:	NCT01175928

Purpose

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.

Condition	Intervention	Phase
Diabetic Polyneuropathy	Device: Sham device Device: NormaTec PCD (Peristaltic Pulse PCD)	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 2 Study of the NormaTec PCD in the Treatment of Diabetic Peripheral Neuropathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Peripheral Nerve Disorders

U.S. FDA Resources

Further study details as provided by NormaTec Industries LP:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

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)

Estimated Enrollment:	60
Study Start Date:	October 2010
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Peristaltic Pulse PCD Peristaltic Pulse Pneumatic Compression Device (NormaTec PCD)	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
Sham Comparator: Sham Device Sham Pneumatic Compression Device (looks and sounds like real device, but applies no compression)	Device: Sham device Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day Other Name: NormaTec PCD (sham device)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175928

Locations

United States, Massachusetts
NormaTec
Newton Center, Massachusetts, United States, 02459

Sponsors and Collaborators

NormaTec Industries LP

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Nicholas Spirito, MD

Saints Medical Center

More Information

No publications provided

Responsible Party:	NormaTec Industries LP
ClinicalTrials.gov Identifier:	NCT01175928 History of Changes
Other Study ID Numbers:	NormaTec_90513134-01, 1R43DK088634-01
Study First Received:	August 3, 2010
Last Updated:	April 18, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by NormaTec Industries LP:

Diabetic polyneuropathy
Pneumatic Compression Device

Additional relevant MeSH terms:

Peripheral Nervous System Diseases
Polyneuropathies
Diabetic Neuropathies
Neuromuscular Diseases

Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2012