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

This study is currently recruiting participants.
Verified June 2011 by Temple University
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
History of Changes

April 17, 2012
April 18, 2012
November 2007
October 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01580917 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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Not Provided
 
Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study
Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control

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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

A community sample
Foot Ulcer, Diabetic
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact: Dana N Tango, BS 215-625-5365 dtango@tuspm.temple.edu
Contact: Reagan Kane, MS 215-625-5365 rjane@tuspm.temple.edu
United States
 
NCT01580917
TUSPM-JF-01
No
Temple University
Temple University
Not Provided
Study Director: Jinsup Song, DPM, PhD Temple University
Principal Investigator: James A Furmato, DPM, PhD Temple University
Temple University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP