Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389636
Status:
UNKNOWN
Last Update Posted:
2008-05-07
First Post:
2006-10-18
Brief Title:
TheraGauze Alone and RegranexGel 001 Plus TheraGauze in the Treatment of Wagner Stage I Diabetic Foot Ulcers
Sponsor:
Solsys Medical LLC
Organization:
Solsys Medical LLC
Study Overview
Official Title:
TheraGauze Alone and RegranexGel 001 Plus TheraGauze in the Treatment of Wagner Stage I Diabetic Foot Ulcers
Status:
UNKNOWN
Status Verified Date:
2008-05
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:
Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers
Detailed Description:
This study will evaluate the use of TheraGauzeT Soluble Systems LLC wound dressing a polymer hydrogel chemically impregnated into a rayonpolyester formed fabric forming a pliable conforming solid matrix TheraGauze is FDA Class I exempt regulation 21CFR product code 58784022 It is hypothesized that this material will be useful for the treatment of full-thickness diabetic ulcers It is further hypothesized that this material will enhance the action of Regranex becaplermin gel by providing an optimal environment for this growth factor to function This study will observe patient outcomes following diabetic foot ulcer treatment with TheraGauze and with or without the use of Regranex
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