NCT01040962

Brief Summary

Fall risk is increased in people with diabetic peripheral neuropathy (DPN) and yet, minimal research has been conducted to identify appropriate fall risk assessment tools and improve our understanding of falls in these individuals. Purpose: The primary purpose of this study is to establish a foundation of knowledge needed to address falls in people with DPN. This will be accomplished through 1) comparing the validity of 4 fall risk assessment tools, 2) identifying risk factors for falls and 3) determining how quality of life is influenced by factors related to falls in people with DPN.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

August 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

December 28, 2009

Last Update Submit

June 15, 2012

Conditions

Keywords

neuropathydiabetes

Study Arms (1)

Falls Risk Assessment, Diabetic Peripheral Neuropathy Patients

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons that have diabetic peripheral neuropathy

You may qualify if:

  • diagnosed with diabetic peripheral neuropathy

You may not qualify if:

  • major medical depression
  • non-diabetes related musculoskeletal problems that limit ambulation
  • open wounds on the weight bearing surfaces of the feet
  • requires another person's assistance to walk
  • uncorrected visual deficits that influence gait and/or balance
  • history of stroke or other CNS pathology that impairs gait and/or balance
  • diagnosed untreated vestibular disorder that results in gait and/or balance disturbances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Steve Jernigan

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 30, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations