Completed

NCT Number: NCT05755750

Intratendinous Genipin Injection in Horses With Tendon Injuries

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.

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Key information

Conditions

Superficial Digital Flexor Tendonitis

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Equine surgery, Vetsuisse-Faculty, University of Zurich

Zurich, Canton of Zurich, 8057, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

clinical and sonographic evidence of a tendon injury

Exclusion criteria

in the final analysis, only superficial digital flexor tendon injuries were included
if follow-up was less than 12 m due to euthanasia, death or other reasons, horses were excluded from the study

Treatment and study plan

Genipin

Drug

Intratendinous genipin injection

Other names: Methyl (1R,4aS,7aS)-1-hydroxy-7-(hydroxymethyl)-1,4a,5,7a-tetrahydrocyclopenta[c]pyran-4-carboxylate

Primary outcomes

Recovery from tendon injury

Time frame: 12 months

The amount of horses that regain AAEP lameness grade 0 (sound; free of lameness) after superficial digital flexor tendon injury

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Clinical and Ultrasonographic Evaluation of Intratendinous Genipin Injection in Horses With Superficial Digital Flexor Tendon Injuries

Important dates

Study start: 2016
Primary completion: 2023
Study completion: 2023
First posted: Mar 6, 2023
Registry last updated: Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.