NCT01175928

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

August 3, 2010

Last Update Submit

April 18, 2012

Conditions

Diabetic Polyneuropathy

Keywords

Diabetic polyneuropathyPneumatic Compression Device

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Sensory perception measurements

    baseline; 1 month; 2 months; 3 months

  • Quality of life questionnaires

    baseline; 1 month; 2 months; 3 months

Study Arms (2)

Peristaltic Pulse PCD

EXPERIMENTAL

Peristaltic Pulse Pneumatic Compression Device (NormaTec PCD)

Device: NormaTec PCD (Peristaltic Pulse PCD)

Sham Device

SHAM COMPARATOR

Sham Pneumatic Compression Device (looks and sounds like real device, but applies no compression)

Device: Sham device

Interventions

Sham deviceDEVICE

Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day

Also known as: NormaTec PCD (sham device)
Sham Device
NormaTec PCD (Peristaltic Pulse PCD)DEVICE

Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day

Also known as: NormaTec PCD
Peristaltic Pulse PCD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NormaTec

Newton Center, Massachusetts, 02459, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Nicholas Spirito, MD

    Saints Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 5, 2010

Study Start

October 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

US(1)