Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304733
Status:
UNKNOWN
Last Update Posted:
2006-03-20
First Post:
2006-03-16
Brief Title:
Wound Healing Total Contact Cast Vs Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Sponsor:
Rehabilitation Centre Amsterdam
Organization:
Rehabilitation Centre Amsterdam
Study Overview
Official Title:
Wound Healing Total Contact Cast Vs Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Status:
UNKNOWN
Status Verified Date:
2001-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Objective to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes
Detailed Description:
In this prospective clinical trail 43 patients with plantar ulcer grade 1 or 2 wagner scale were randomized to one of two off-loading modalities total contact cast or custom-made temporary footwearoutcomes assessed were wound surface area reduction square cmand time to wound healing days0 at 248 and 16 weeks to evaluate safety possible side effects were recorded at each follow-up visit
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