Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-02-21 @ 1:33 AM
Study NCT ID:
NCT05160532
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2021-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function, pain, and stiffness in individuals with knee OA. Total scores range from 0-100, with higher scores indicating worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks', 'description': 'Measured using a visual analogue scale with 0 = no pain and 10=worst pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to learn more about treating Symptomatic Knee Osteoarthritis (OA) with an ultrasound-guided hypertonic dextrose injection. Researchers would like to determine best practice for injection frequency and effectiveness of the dextrose injection for symptomatic knee OA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of knee OA by clinical criteria (American College of Rheumatology).\n* Identification of knee osteoarthritis by a radiologist on an existing knee radiograph obtained within 3 years of enrollment.\n* Moderate to severe knee pain for at least 3 months, defined as a score of ≥ 4 (on a 0-10 point numeric rating scale) in response to the question "What is the average level of your left/right knee pain in the past 3 months?".\n\nExclusion Criteria:\n\n* Pregnancy.\n* Diabetes.\n* Anticoagulation therapy.\n* History of total knee replacement.\n* Prior knee prolotherapy or other regenerative product.\n* Any knee injection within 3 months.\n* Inflammatory (RA, gout, pseudogout etc.) or postinfectious knee arthritis.\n* Daily use of opioid medication.\n* Allergy or intolerance to study medication, corn allergy.\n* Body mass index (BMI) greater than 40 kg/m\\^2.\n* Comorbidity severe enough to prevent participation in the study protocol.'}, 'identificationModule': {'nctId': 'NCT05160532', 'briefTitle': 'Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '21-008778'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Four injections of placebo', 'description': 'Subjects will receive four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'One injection of DPT and three injections of placebo', 'description': 'Subjects will receive one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.', 'interventionNames': ['Drug: Placebo', 'Drug: Dextrose prolotherapy (DPT)']}, {'type': 'EXPERIMENTAL', 'label': 'Two injections of DPT and two injections of placebo', 'description': 'Subjects will receive two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.', 'interventionNames': ['Drug: Placebo', 'Drug: Dextrose prolotherapy (DPT)']}, {'type': 'EXPERIMENTAL', 'label': 'Four injections of DPT', 'description': 'Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).', 'interventionNames': ['Drug: Dextrose prolotherapy (DPT)']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '5ml of normal saline (NS)', 'armGroupLabels': ['Four injections of placebo', 'One injection of DPT and three injections of placebo', 'Two injections of DPT and two injections of placebo']}, {'name': 'Dextrose prolotherapy (DPT)', 'type': 'DRUG', 'description': '25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.', 'armGroupLabels': ['Four injections of DPT', 'One injection of DPT and three injections of placebo', 'Two injections of DPT and two injections of placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'David Patchett, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David C. Patchett, DO', 'investigatorAffiliation': 'Mayo Clinic'}}}}