Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330265
Status:
UNKNOWN
Last Update Posted:
2008-08-26
First Post:
2006-05-24
Brief Title:
Safety and Efficacy Study of an Interactive Wound Dressing KC002 for the Treatment of Diabetic Foot Ulcers
Sponsor:
KeraCure
Organization:
KeraCure
Study Overview
Official Title:
A Prospective Randomized Controlled Unmasked Multiple Treatment Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes Versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers
Status:
UNKNOWN
Status Verified Date:
2008-08
Last Known Status:
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:
KC-002PT
Brief Summary:
The objective of this study is to determine the safety and effectiveness of a device the KC-002 interactive wound dressing in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus
This is a prospective randomized multi-center unmasked controlled study All patients will receive care for the diabetic foot ulcer during the study
Participation in the study is for 24 weeks
This is a prospective randomized multi-center unmasked controlled study All patients will receive care for the diabetic foot ulcer during the study
Participation in the study is for 24 weeks
Detailed Description:
None
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