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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01580917

Acronym

ILH

Enrollment

Registered

2012-04-19

Start date

2007-11-30

Completion date

2015-10-31

Last updated

2016-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Ulcer, Diabetic

Keywords

laser doppler anemometry, dynamic testing of tissue mechanical property, diabetic foot complications, ulcer genesis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results