Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446472
Status:
UNKNOWN
Last Update Posted:
2010-06-04
First Post:
2007-03-08
Brief Title:
Evaluation of Windowed Casts With and Without Regranex Gel for Healing Diabetic Neuropathic Ulcers
Sponsor:
Southern California Institute for Research and Education
Organization:
Southern California Institute for Research and Education
Study Overview
Official Title:
Evaluation of Windowed Casts With and Without Regranex Gel for Healing
Status:
UNKNOWN
Status Verified Date:
2010-06
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:
None
Brief Summary:
The objective of this study is to compare the effectiveness and safety of windowed casts with Regranex topical becaplermin gel versus placebo inactive medication for treatment of diabetic ulcers on the legs and feet
Detailed Description:
Management of diabetic leg or foot ulcers is based on certain principals 1 effective off-loading of pressure on the wound via specialized shoes cast braces or casts 2 removal of infected or necrotic tissue vial surgery or non-surgical methods and 3 optimization of wound healing by interventions that promote wound repair such as nutritional support provision of optimal moisture balance and growth factor therapy
Application of casts or cast braces below knee removable boots with protective padding to protect and immobilize the ankle and foot have been demonstrated to provide superior wound healing than less cumbersome types of shoe gear 1-3 The benefit of casting may be the result of more effective off-loading of pressure than can be achieved with other devices but the inability of patients to remove their casts also appears to an important factor as non-compliance with removable cast-braces has been shown to be a pervasive and significant issue 45 One critical concept in diabetic foot ulcer management is the relation between chronically and limb loss - for each year a wound persists a patient has a 25 risk for major amputation due to complications from infection 6-8 Limb loss has a profound effect on Diabetics quality of life and rate of lower limb loss among diabetics is four per 1000 person years in comparison with three per 10000 person years 9-10
Application of casts or cast braces below knee removable boots with protective padding to protect and immobilize the ankle and foot have been demonstrated to provide superior wound healing than less cumbersome types of shoe gear 1-3 The benefit of casting may be the result of more effective off-loading of pressure than can be achieved with other devices but the inability of patients to remove their casts also appears to an important factor as non-compliance with removable cast-braces has been shown to be a pervasive and significant issue 45 One critical concept in diabetic foot ulcer management is the relation between chronically and limb loss - for each year a wound persists a patient has a 25 risk for major amputation due to complications from infection 6-8 Limb loss has a profound effect on Diabetics quality of life and rate of lower limb loss among diabetics is four per 1000 person years in comparison with three per 10000 person years 9-10
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