Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT01979666
Status:
TERMINATED
Last Update Posted:
2024-04-02
First Post:
2013-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitrate Patch Use as Treatment of Knee AVN
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
the Effect of a Nitrate Patch on the Healing Process of AVN of the Knee
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to recruit patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates induce peripheral vasodilation and may improve blood supply to the affected tissue.
This study aims to test whether the use of a nicotine patch may accelerate the healing process from AVN of the knee.
This study aims to test whether the use of a nicotine patch may accelerate the healing process from AVN of the knee.
Detailed Description:
The main purpose of this study is to examine whether treatment with a local nitrate patch will improve MRI findings and clinical outcomes in patients with AVN of the knee.
This is a double-blind prospective study that will include 50 adult volunteers, randomly assigned to a "nitrate" group that will be given a nitrate patch, and a "placebo" group that will be given a placebo patch.
The following outcomes will be measured:
* MRI findings before and after the patch treatment
* Use of analgesics
* Subjective pain relief.
This is a double-blind prospective study that will include 50 adult volunteers, randomly assigned to a "nitrate" group that will be given a nitrate patch, and a "placebo" group that will be given a placebo patch.
The following outcomes will be measured:
* MRI findings before and after the patch treatment
* Use of analgesics
* Subjective pain relief.
Study Oversight
Has Oversight DMC:
False
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?: