Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study

NCT ID: NCT01580917

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this pilot study is to compare the dynamic response of microcirculation in the skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic subjects with a history of foot ulcer and 25 age-matched healthy controls to better understand the role of local hypoxia in neuropathic foot ulceration in subjects with diabetes.

The investigators hypothesize that if they apply a gait simulating load to the plantar foot and measure microvascular function, diabetic individuals will demonstrate an increased delay in reestablishing microvascular flow compared to healthy individuals.

Detailed Description

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Conditions

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Foot Ulcer, Diabetic

Keywords

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laser doppler anemometry dynamic testing of tissue mechanical property diabetic foot complications ulcer genesis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diabetic Test

Diabetic individuals with a history of previous plantar ulcer and a high risk of developing a foot ulceration

No interventions assigned to this group

Healthy Controls

Non-diabetic, healthy individuals with low risk of developing a neurogenic foot ulcer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* between ages 40 and 75
* history of diabetic neuropathic plantar ulcer (test subjects)
* no history of diabetes (control subjects)
* no peripheral sensory neuropathy (control subjects)

Exclusion Criteria

* amputation or surgery on right Great Toe
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinsup Song, DPM, PhD

Role: STUDY_DIRECTOR

Temple University

James A Furmato, DPM, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Temple University School of Podiatric Medicine Gait Study Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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TUSPM-JF-01

Identifier Type: -

Identifier Source: org_study_id