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A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk

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ClinicalTrials.gov Identifier: NCT00013286
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
VA Office of Research and Development

Brief Summary:

This project will identify risk factors for diabetic foot ulcer by studying the relationship between endothelial dysfunction and foot ulcer risk. A fundamental defect in type 1 and 2 diabetic subjects is impaired vasodilatory reserve which is reflected in the dysfunction of endothelium-dependent vasodilation. Findings thus far point to an important role of the microvasculature in the development of diabetic foot ulcer and amputation.

In this study a a well-characterized cohort of 750 diabetic veterans without foot ulcer will be followed over 3-years.


Condition or disease Intervention/treatment
Diabetic Foot Ulcers Device: Prevention Diabetic Foot Ulcer

Detailed Description:

Prevention of foot ulcer should result in a reduction in the risk of lower limb amputation. We propose to identify risk factors for diabetic foot ulcer by studying the relationship between endothelial dysfunction and foot ulcer risk. It has been proposed that impaired vasoregulation in diabetic patients leads to the development and perpetuation of chronic foot ulceration via failure of the normal hyperemic response to injury. A fundamental defect that has been demonstrated in type 1 and 2 diabetic subjects is impaired vasodilatory reserve, which reflects dysfunction of endothelium-dependent vasodilation. Our findings thus far point to an important role of the microvasculature in the development of diabetic foot ulcer and amputation, with our demonstration of higher foot ulcer and lower-limb amputation risk in relation to lower dorsal foot transcutaneous oxygen level. The role of endothelial dysfunction in relation to diabetic foot ulcer risk has not previously been studied.

We will follow a well-characterized cohort of 750 diabetic veterans without foot ulcer over 3-year after obtaining baseline measures of endothelial function using iontophoretic application of acetylcholine to induce cutaneous endothelium-dependent vasodilation on the dorsal foot. Iontophoresis permits noninvasive delivery of ionic drugs cutaneously without damage to the skin or systemic effects. Change in microvascular flow will be measured using a laser Doppler imager (Moor LDI) over a 4x4 cm area divided into 18496 measurement sites. Endothelial function will be defined as the difference between readings before and after the iontophoretic application of a 1% acetylcholine solution at a current of 0.2 mA for 1 minute, with higher readings reflecting better endothelial function. These techniques are the accepted standard method for assessment of endothelium-dependent vasodilation in the cutaneous microvasculature. Additional measurements will be obtained on other ulcer risk factors to assess whether endothelial dysfunction independently influences foot ulcer risk, or whether it is merely a marker for different pathophysiologic conditions responsible for higher risk (eg., sensory neuropathy). Possible confounding factors considered will include sensory and autonomic neuropathy; dorsal foot transcutaneous oximetry; macrovascular function assessed with Doppler blood pressures; diabetes characteristics; in-shoe plantar pressure (F-scan), medication use, and foot deformity.


Study Type : Observational
Enrollment : 750 participants
Time Perspective: Prospective
Official Title: A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk
Study Start Date : October 1999
Actual Study Completion Date : September 2002

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Diabetic patients with foot ulcers

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013286


Locations
United States, Washington
VAMC, Seattle, WA
Seattle, Washington, United States
Sponsors and Collaborators
VA Office of Research and Development
Investigators
OverallOfficial: John Fryer, Ph.D. Asst. Director Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
OverallOfficial: Wijegupta Ellepola, Program Analyst Program Analysis & Review Section (PARS), Rehabilitation Research & Development Service

ClinicalTrials.gov Identifier: NCT00013286     History of Changes
Obsolete Identifiers: NCT00011271
Other Study ID Numbers: A2016R
First Posted: March 16, 2001    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: January 2001

Keywords provided by VA Office of Research and Development:
Diabetes mellitus, foot ulcer, endothelium

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases