Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-28 @ 6:19 PM
Study NCT ID:
NCT01518335
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2011-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2011-12-08', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function.', 'timeFrame': 'Day 0; Day2-3; Day 8-10; Day30', 'description': 'The primary outcome of this investigation is change from baseline in LEFS score, a previous validated 80-point scale used to quantify lower extremity function. A difference of 9 points is considered clinically significant.'}], 'secondaryOutcomes': [{'measure': 'Change in pain from baseline', 'timeFrame': 'Day 0; Day 2-3, Day 8-10, Day 30', 'description': 'Changes in level of pain from baseline was measured using VAS scale as well as comparing need for narcotics use at each follow up time point.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['platelet rich plasma', 'ankle', 'sprain', 'injection', 'Platelet Rich Plasma therapy', 'focal, invasive therapy for sprains'], 'conditions': ['Sprain of Ankle']}, 'descriptionModule': {'briefSummary': 'This research study hopes to determine whether or not platelet rich plasma therapy improves healing time of moderate to severe ankle sprain in comparison to standard of care therapy.', 'detailedDescription': "The intention of this research project is to study a new treatment for severe ankle sprains.This new treatment is called Platelet Rich Plasma (PRP) therapy and involves injecting concentrated platelet's from a patient's own blood into the site of injury to aid healing. Platelets, aside from their clotting capabilities also serve a role in re-vascularization of tissue as well as collagen repair. PRP therapy has been used in sports medicine for treatment of chronic injuries but has yet to be proven effective in acute injury of a joint. The investigators are comparing treatment and placebo groups based on a subjective patient questionnaire and pain score administered on the day of injury and 2-3 days and 8-10 days follow up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe ankle sprain\n* X-ray completed\n\nExclusion Criteria:\n\n* Pregnancy/breastfeeding\n* Police custody\n* active infection\n* metastatic disease/tumors\n* History of thrombocytopenia\n* Allergy to ester or amine anesthetics\n* On anticoagulant medication\n* Peripheral vascular disease\n* Known coagulopathy'}, 'identificationModule': {'nctId': 'NCT01518335', 'acronym': 'PRP', 'briefTitle': 'Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein Healthcare Network'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo Controlled Study Evaluating the Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department.', 'orgStudyIdInfo': {'id': 'HN4157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet Rich Plasma', 'description': 'Patients receive Platelet rich plasma injection + standard of care therapy(bandaging or boot and crutches) + non-NSAID pain medicine', 'interventionNames': ['Procedure: Platelet rich plasma injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/Standard of Care', 'description': 'Patient receives Placebo Comparator: Placebo/Standard of Care \\[saline injection + standard of care (bandaging or boot and crutches)\\] + non-NSAID pain medicine', 'interventionNames': ['Procedure: Placebo Comparator: Placebo/Standard of Care']}], 'interventions': [{'name': 'Platelet rich plasma injection', 'type': 'PROCEDURE', 'description': '50ml of blood drawn into a 60cc with 10cc of anticoagulant is processed using MAGELLAN® Autologous Platelet (Arteriocyte Medical Systems, Cleveland Ohio)to separate out approximately 3-6 cc of platelet rich plasma, which is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.', 'armGroupLabels': ['Platelet Rich Plasma']}, {'name': 'Placebo Comparator: Placebo/Standard of Care', 'type': 'PROCEDURE', 'description': '50ml of blood is drawn into a 60cc with 10cc of anticoagulant and is then discarded. 4 cc of saline solution is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.', 'armGroupLabels': ['Placebo/Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Einstein Healthcare Network', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Adam Rowden, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eisntein Healthcare Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein Healthcare Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'James Gardner, MD', 'investigatorAffiliation': 'Albert Einstein Healthcare Network'}}}}