Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT00304733
Status:
UNKNOWN
Last Update Posted:
2006-03-20
First Post:
2006-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Sponsor:
Rehabilitation Centre Amsterdam
Organization:
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 footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: