Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study (ILH)
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.
Foot Ulcer, Diabetic
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control|
- Latency time after occlusive loading [ Time Frame: approximately 2.75 minutes after start of collection protocol ] [ Designated as safety issue: No ]The time between removal of occluding pressure and the initiation of the post-occlusive hyperemic response as measured by laser Doppler.
- Response time to baseline [ Time Frame: 2.75 seconds after start of collection protocol ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]The time interval between the start of the post-occlusive hyperemic response and the time to reach maximum flow as measured by laser doppler
|Study Start Date:||November 2007|
|Study Completion Date:||October 2015|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Diabetic individuals with a history of previous plantar ulcer and a high risk of developing a foot ulceration
Non-diabetic, healthy individuals with low risk of developing a neurogenic foot ulcer
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580917
|United States, Pennsylvania|
|Temple University School of Podiatric Medicine Gait Study Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Director:||Jinsup Song, DPM, PhD||Temple University|
|Principal Investigator:||James A Furmato, DPM, PhD||Temple University|