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

Completed

• Conditions: Foot Ulcer, Diabetic

• Registration Number: NCT01580917
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2016-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Latency time after occlusive loading	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

Name	Time	Method
Response time to baseline	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.
Response time to Maximum Flow	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

Trial Locations

Locations (1)

Temple University School of Podiatric Medicine Gait Study Center; 🇺🇸 Philadelphia, Pennsylvania, United States