Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013299
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-03-14
Brief Title:
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 23
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 23
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 is a randomized clinical trial to 1 Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers and 2 Estimate costs of ulcer prevention using these strategies
Detailed Description:
This is a randomized clinical trial to 1 Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of footulcers and 2 Estimate costs of ulcer prevention using these strategies Patients from the Seattle VA n214 and Group Health Cooperative n213 will be randomly assigned to one of two study arms They are 1 patients wearing study shoes and premolded polyurethane insoles and 2 the control group of patients wearing their own footwear
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