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

NCT01580917 | Completed

• 1 other identifier: TUSPM-JF-01
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Ulcer, Diabetic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Latency time after occlusive loading

  The time between removal of occluding pressure and the initiation of the post-occlusive hyperemic response as measured by laser Doppler.

  approximately 2.75 minutes after start of collection protocol

Secondary Outcomes (2)

• 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 Arms (2)

Diabetic Test

Diabetic individuals with a history of previous plantar ulcer and a high risk of developing a foot ulceration

Healthy Controls

Non-diabetic, healthy individuals with low risk of developing a neurogenic foot ulcer

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A community sample

You may qualify if:

• 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)

You may not qualify if:

• amputation or surgery on right Great Toe

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University School of Podiatric Medicine Gait Study Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• Jinsup Song, DPM, PhD

  Temple University

  STUDY DIRECTOR

• James A Furmato, DPM, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 19, 2012
• Study Start: November 1, 2007
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)