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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Temple University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01580917
First received: April 17, 2012
Last updated: April 18, 2012
Last verified: June 2011
  Purpose

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
Foot Ulcer, Diabetic

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Latency time after occlusive loading [ Time Frame: approximately 2.75 minutes after start of collection protocol ] [ Designated as safety issue: No ]
    The time between removal of occluding pressure and the initiation of the post-occlusive hyperemic response as measured by laser Doppler.


Secondary Outcome Measures:
  • Response time to baseline [ Time Frame: 2.75 seconds after start of collection protocol ] [ Designated as safety issue: No ]
    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.

  • Response time to Maximum Flow [ Time Frame: At least 2.75 seconds after the start of collection protocol. ] [ Designated as safety issue: No ]
    The time interval between the start of the post-occlusive hyperemic response and the time to reach maximum flow as measured by laser doppler


Estimated Enrollment: 50
Study Start Date: November 2007
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580917

Contacts
Contact: Dana N Tango, BS 215-625-5365 dtango@tuspm.temple.edu
Contact: Reagan Kane, MS 215-625-5365 rjane@tuspm.temple.edu

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

No publications provided

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01580917     History of Changes
Other Study ID Numbers: TUSPM-JF-01
Study First Received: April 17, 2012
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014