Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 7:01 PM
Study NCT ID:
NCT05755750
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2023-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intratendinous Genipin Injection in Horses With Tendon Injuries
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Clinical and Ultrasonographic Evaluation of Intratendinous Genipin Injection in Horses With Superficial Digital Flexor Tendon Injuries
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
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:
Our study is the first to use genipin, a naturally occurring collagen cross-linking agent, as a therapeutic agent to treat superficial digital flexor tendon (SDFT) injuries in horses. The promising approach of intratendinous genipin injection and tendon mechanical enhancement could be a viable alternative to current therapies for SDFT injuries.
Detailed Description:
Tendon injuries are a career limiting or ending condition in horses. Genipin (GP), an exogenous collagen crosslinker, provides ex-vivo tendon mechanical augmentation and excellent biosafety. The main objective of this study is to investigate treatment success of GP-induced collagen crosslinking in a clinical application in horses with superficial digital flexor tendon (SDFT) injuries. Horses with an AAEP (American Association of American Practitioners) lameness score \> 0 and sonographically confirmed tendinopathy are treated with intratendinous GP injection (IGI) and controlled exercise. Minimal follow-up was set at 12 months. Outcome factors are lameness (AAEP lameness score), soundness, assessment of return to previous use, and re-injury. Additionally, adverse effects are recorded.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: