Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013286
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-03-14
Brief Title:
A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
In this study a a well-characterized cohort of 750 diabetic veterans without foot ulcer will be followed over 3-years
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 02 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
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 02 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None