NCT00822198

Brief Summary

The purpose of this study is to assess the effect of vibration of the plantar surface of the foot on peripheral neuropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

1.4 years

First QC Date

January 13, 2009

Last Update Submit

January 13, 2009

Conditions

Peripheral Neuropathy

Keywords

peripheral neuropathydiabetesplantar vibration

Outcome Measures

Primary Outcomes (1)

  • intraepidermal nerve fiber density in ankle and thigh

    0, 6 and 12 months

Secondary Outcomes (2)

  • quality of life score

    0, 6 and 12 months

  • clinical assessment of peripheral neuropathy

    0, 6 and 12 months

Study Arms (1)

plantar vibration

EXPERIMENTAL

Subject will use Juvent plantar vibration device daily in the home or office for six months.

Device: plantar vibration

Interventions

plantar vibrationDEVICE

Subjects in the experimental component of the trial will be provided with a Juvent 1000-CS device in their home or workplace. The device will be placed in a convenient location where the device does not represent a trip hazard, and yet is readily accessible for use. The subjects will be instructed to use the device whenever it is convenient to do so, either by standing on the device, or by sitting with their feet on the device. Downloads of usage data will be obtained intermittently. Period interviews with the subjects will be conducted to ensure that the device is operating and that no problems are encountered with device usage.

plantar vibration

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical evidence of neuropathy
  • Normal to moderate evidence of neuropathy on nerve conduction studies

You may not qualify if:

  • Currently on medications with a known risk of neuropathy
  • Pregnant
  • Evidence of peripheral vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurology Associates

Corning, New York, 14830, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Leann M Lesperance, MD, PhD

    Binghamton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

March 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

US(1)