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

Foot Ulcer, Diabetic Clinical Trial

— ILH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580917
• Other study ID #: TUSPM-JF-01
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: December 14, 2016
• Start date: November 2007
• Est. completion date: October 2015

Study information

• Verified date: December 2016
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic

Locations

Country	Name	City	State
United States	Temple University School of Podiatric Medicine Gait Study Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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.	No