Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT05971004
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2023-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}], 'ancestors': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-30', 'studyFirstSubmitDate': '2023-07-17', 'studyFirstSubmitQcDate': '2023-07-30', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC', 'timeFrame': '6 months', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.'}], 'secondaryOutcomes': [{'measure': 'VAS (Visual Analogue Pain)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Visual Analogue Pain assessing pain from 0 (no pain) to 10 (unbearable pain)'}, {'measure': 'Ultrasound', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Ultrasound evaluation for hypoechoic (signal reduction), normal, and hyperechoic (signal amplification) ligaments. Hypoechoic signal suggests damage or degeneration of the ligament; normal signal suggests healthy ligament tissue; hyperechoic signal suggests calcification, scar, or inflammation.'}, {'measure': 'Likert', 'timeFrame': 'Baseline, 6 months', 'description': "Likert scale for patients' satisfaction from 1 (no statisfaction) to 5 (maximum satisfaction)"}, {'measure': 'WOMAC', 'timeFrame': 'Baseline, 3 months', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Collateral Ligament Pain', 'Knee Pain', 'Knee Instability', 'Sports Trauma', 'Collagen Peptide Injections', 'Ligament Healing'], 'conditions': ['Collateral Ligament Injury of Stifle Joint']}, 'descriptionModule': {'briefSummary': 'Conducted by Binh Luu Thi, Lan Tran Thi, and Minh Hang Hoang Thi at Thai Nguyen National Hospital, the study investigates a new approach to treating persistent collateral ligament pain, common among athletes. The research examines the therapeutic use of hydrolyzed collagen peptide injections, a treatment that addresses pain and inflammation in ways previous methods have not.\n\nThe study involves a randomized controlled trial with 62 patients, all diagnosed with inflammation in the collateral ligament site. The patients are split into two groups: one receiving collagen injections alongside oral painkillers and the other receiving depo-medrol injections with oral painkillers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age above 18 years,\n* lateral knee pain with a duration of 3 months or longer,\n* ultrasound evidence of inflammation of the femoral condyle attachment point,\n* agreement to participate in the study\n\nExclusion Criteria:\n\n* trauma,\n* infection,\n* dermatitis at the site of the inflammation,\n* damage to surrounding knee structures,\n* history of chronic inflammatory arthritis (such as gout or rheumatoid arthritis),\n* local corticosteroid injection within 3 months before participating in the study.'}, 'identificationModule': {'nctId': 'NCT05971004', 'briefTitle': 'Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain', 'organization': {'class': 'INDUSTRY', 'fullName': "Tiss'You srl"}, 'officialTitle': 'Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Collagen Peptide Ligament'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collagen Peptide Group', 'description': "The Collagen Peptide Group (31 patients) received oral pain relievers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point (femoral condyle).", 'interventionNames': ['Device: Arthrys (Collagen Peptide solution)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cortison Group', 'description': 'The Cortison Group (31 patients) received oral painkillers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar 50mg) for 3 consecutive months.', 'interventionNames': ['Drug: Depo medrol']}], 'interventions': [{'name': 'Arthrys (Collagen Peptide solution)', 'type': 'DEVICE', 'description': "one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point", 'armGroupLabels': ['Collagen Peptide Group']}, {'name': 'Depo medrol', 'type': 'DRUG', 'description': 'one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar 50mg) for 3 consecutive months.', 'armGroupLabels': ['Cortison Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47895', 'city': 'Domagnano', 'state': 'RSM', 'country': 'San Marino', 'facility': "Tiss'You", 'geoPoint': {'lat': 43.94961, 'lon': 12.46828}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Tiss'You srl", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Prof. Binh Luu Thi', 'investigatorAffiliation': "Tiss'You srl"}}}}