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

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.

Study Overview

• Status: Completed
• Conditions: Foot Ulcer, Diabetic

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Temple University School of Podiatric Medicine Gait Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A community sample

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Temple University
• Investigators: Study Director: Jinsup Song, DPM, PhD, Temple University; Principal Investigator: James A Furmato, DPM, PhD, Temple University

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 19, 2012

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: laser doppler anemometry; dynamic testing of tissue mechanical property; diabetic foot complications; ulcer genesis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: TUSPM-JF-01