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

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ClinicalTrials.gov Identifier: NCT01580917
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Temple University

Brief Summary:

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.


Condition or disease
Foot Ulcer, Diabetic

Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control
Study Start Date : November 2007
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Group/Cohort
Diabetic Test
Diabetic individuals with a history of previous plantar ulcer and a high risk of developing a foot ulceration
Healthy Controls
Non-diabetic, healthy individuals with low risk of developing a neurogenic foot ulcer



Primary Outcome Measures :
  1. Latency time after occlusive loading [ Time Frame: approximately 2.75 minutes after start of collection protocol ]
    The time between removal of occluding pressure and the initiation of the post-occlusive hyperemic response as measured by laser Doppler.


Secondary Outcome Measures :
  1. Response time to baseline [ Time Frame: 2.75 seconds after start of collection protocol ]
    The time interval between the start of post-occlusive hyperemic response and when the response curve reaches the baseline, or reference, flow level as measured by laser doppler.

  2. Response time to Maximum Flow [ Time Frame: At least 2.75 seconds after the start of collection protocol. ]
    The time interval between the start of the post-occlusive hyperemic response and the time to reach maximum flow as measured by laser doppler



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A community sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580917


Locations
United States, Pennsylvania
Temple University School of Podiatric Medicine Gait Study Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Temple University
Investigators
Study Director: Jinsup Song, DPM, PhD Temple University
Principal Investigator: James A Furmato, DPM, PhD Temple University

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01580917     History of Changes
Other Study ID Numbers: TUSPM-JF-01
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016

Keywords provided by Temple University:
laser doppler anemometry
dynamic testing of tissue mechanical property
diabetic foot complications
ulcer genesis

Additional relevant MeSH terms:
Foot Ulcer
Diabetic Foot
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies