Skip to main content
Clinical Trials/NCT01580917
NCT01580917
Completed
Not Applicable

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

Temple University1 site in 1 country18 target enrollmentNovember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Foot Ulcer, Diabetic
Sponsor
Temple University
Enrollment
18
Locations
1
Primary Endpoint
Latency time after occlusive loading
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
October 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

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(2.75 seconds after start of collection protocol)
  • Response time to Maximum Flow(At least 2.75 seconds after the start of collection protocol.)

Study Sites (1)

Loading locations...

Similar Trials