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

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.

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Key information

Conditions

Foot Ulcer, Diabetic Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Temple University School of Podiatric Medicine Gait Study Center

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Latency time after occlusive loading

Time frame: 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 outcomes

Response time to baseline

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

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

Acronym: ILH

Important dates

Study start: 2007
Primary completion: 2015
Study completion: 2015
First posted: Apr 19, 2012
Registry last updated: Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed