Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-02 @ 2:35 AM
Study NCT ID:
NCT05755750
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2023-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intratendinous Genipin Injection in Horses With Tendon Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C007834', 'term': 'genipin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-02-22', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery from tendon injury', 'timeFrame': '12 months', 'description': 'The amount of horses that regain AAEP lameness grade 0 (sound; free of lameness) after superficial digital flexor tendon injury'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Superficial Digital Flexor Tendonitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical and sonographic evidence of a tendon injury\n\nExclusion Criteria:\n\n* in the final analysis, only superficial digital flexor tendon injuries were included\n* if follow-up was less than 12 m due to euthanasia, death or other reasons, horses were excluded from the study'}, 'identificationModule': {'nctId': 'NCT05755750', 'briefTitle': 'Intratendinous Genipin Injection in Horses With Tendon Injuries', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Clinical and Ultrasonographic Evaluation of Intratendinous Genipin Injection in Horses With Superficial Digital Flexor Tendon Injuries', 'orgStudyIdInfo': {'id': 'Genipin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intratendinous genipin injection', 'description': 'Genipin was administrated intratendinously under sonographic guidance. For lesions up to 3 cm in length, two separate 0.2 ml injections of genipin solution were administered into the region of transition from degenerated to normal tendon tissue. One injection was given at the proximal end of the lesion and the other at the distal end.\n\nFor lesions longer than 3 cm, an additional 0.2 ml injection was used for every additional 3 cm of lesion length. In the illustrated example, the 6 cm lesion required a total of three injections, and therefore one additional injection was given in the middle of the lesion between the distal and proximal injections.\n\nGenipin treatment solution contained 100 mM genipin and 20% of the solvent dimethyl sulfoxidee in phosphate buffered saline. Instead of one administration of a relatively large volume, several individual administrations of 0.2 ml were performed depending on lesion size .', 'interventionNames': ['Drug: Genipin']}], 'interventions': [{'name': 'Genipin', 'type': 'DRUG', 'otherNames': ['Methyl (1R,4aS,7aS)-1-hydroxy-7-(hydroxymethyl)-1,4a,5,7a-tetrahydrocyclopenta[c]pyran-4-carboxylate'], 'description': 'Intratendinous genipin injection', 'armGroupLabels': ['Intratendinous genipin injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8057', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Equine surgery, Vetsuisse-Faculty, University of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Fürst Anton, Prof Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor, Head of Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. vet.', 'investigatorFullName': 'Corsin Heim', 'investigatorAffiliation': 'University of Zurich'}}}}