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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Polyneuropathy
• Intervention / Treatment: Device: NormaTec PCD (Peristaltic Pulse PCD); Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: NormaTec PCD (sham device)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerve Conduction Studies	Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).	3 months
Nerve Conduction Studies	Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).	1 month
Nerve Conduction Studies	Nerve conduction studies of the peroneal motor nerve performed bilaterally (amplitude, velocity, distal latency).	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory perception measurements	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.	baseline; 1 month; 2 months; 3 months
Quality of life questionnaires	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)	baseline; 1 month; 2 months; 3 months

Collaborators and Investigators

• Sponsor: NormaTec Industries LP
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Nicholas Spirito, MD, Saints Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: August 3, 2010
• First Submitted That Met QC Criteria: August 3, 2010
• First Posted (Estimate): August 5, 2010

Study Record Updates

• Last Update Posted (Estimate): April 20, 2012
• Last Update Submitted That Met QC Criteria: April 18, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Diabetic polyneuropathy; Pneumatic Compression Device
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies
• Other Study ID Numbers: NormaTec_90513134-01; 1R43DK088634-01 (U.S. NIH Grant/Contract)