Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT02352467
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2015-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Aurix Therapy in Pressure Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2015-01-28', 'studyFirstSubmitQcDate': '2015-01-28', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Heal', 'timeFrame': '16 weeks', 'description': 'Compare complete wound healing at 16 weeks for all pressure ulcers treated with Aurix plus standard of care with patients randomized to usual and customary care. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment, 2006).'}], 'secondaryOutcomes': [{'measure': 'Proportion of healed ulcers', 'timeFrame': '16 weeks', 'description': 'Proportion of patients with completely healed pressure ulcers'}, {'measure': 'W-QOL (Quality of Life with Chronic Wounds) score', 'timeFrame': '16 weeks', 'description': 'Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non Healing Wound'], 'conditions': ['Pressure Ulcer']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary Care.', 'detailedDescription': 'Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of Aurix to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard of care to determine time to heal at 16 weeks. Comparison will be made to patients receiving undefined Usual and Customary Care in a 1:1 manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Medicare eligible\n2. ≥18 years of age\n3. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)\n4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter\n5. For subjects with potentially multiple eligible PUs, the largest ulcer will be selected as the Index Ulcer for study. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)\n6. Debrided ulcer size between 3 cm2 and 200 cm2\n7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic\n8. Demonstrated adequate pressure relief regimen\n9. Duration ≥ 1 month at first visit\n10. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.\n\nExclusion Criteria:\n\n1. Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin\n2. Stage I pressure ulcers\n3. Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound\n4. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by Aurix\n5. Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)\n6. Patients on chemotherapeutic agents or any malignancy in the wound area\n7. Subjects who are cognitively impaired\n8. Serum albumin of less than 2.5 g/dL\n9. Plasma Platelet count of less than 100 x 109/L\n10. Hemoglobin of less than 10.5 g/dL\n11. Subject has inadequate venous access for repeated blood draw required for Aurix Administration.\n12. Life expectancy of \\< 6 months.'}, 'identificationModule': {'nctId': 'NCT02352467', 'briefTitle': 'Effectiveness of Aurix Therapy in Pressure Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nuo Therapeutics'}, 'officialTitle': 'A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers', 'orgStudyIdInfo': {'id': 'CM004 Gold'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aurix + UCC', 'description': 'Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive Aurix treatment and usual and customary care, which can include advanced therapeutics.', 'interventionNames': ['Device: Aurix']}, {'type': 'NO_INTERVENTION', 'label': 'Usual and Customary Care', 'description': 'Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive usual and customary care, which can include advanced therapeutics.'}], 'interventions': [{'name': 'Aurix', 'type': 'DEVICE', 'description': 'Aurix is a platelet-rich plasma gel used in the treatment of non-healing wounds. It will be administered twice weekly for 2 weeks then weekly.', 'armGroupLabels': ['Aurix + UCC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91007', 'city': 'Arcadia', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Villarama', 'role': 'CONTACT', 'phone': '626-898-8927'}], 'facility': 'Methodist Hospital Wound Care Center', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '90640', 'city': 'Montebello', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Omar Sabha', 'role': 'CONTACT', 'phone': '323-726-1222'}], 'facility': 'Beverly Hospital Wound and Hyperbaric Center', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'zip': '93277', 'city': 'Visalia', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Klara Bergholdt', 'role': 'CONTACT', 'email': 'kbergtho@kdhcd.org', 'phone': '559-624-3944'}, {'name': 'Beth Hirsch, NP', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kaweah Delta Rehabiliation Hospital', 'geoPoint': {'lat': 36.33023, 'lon': -119.29206}}, {'zip': '06410', 'city': 'Bristol', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristopher Jones', 'role': 'CONTACT', 'email': 'kristopher.jones@restorixhealth.com', 'phone': '860-585-3397'}], 'facility': 'Bristol Hospital Wound Care Center', 'geoPoint': {'lat': 41.67176, 'lon': -72.94927}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ronald Devine, MD', 'role': 'CONTACT', 'phone': '404-351-8873'}, {'name': 'Teri Biven', 'role': 'CONTACT', 'phone': '404-351-8873'}], 'facility': 'Piedmont', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '86342', 'city': 'Meridian', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lydia Nixt', 'role': 'CONTACT', 'email': 'nixtl@slhs.org', 'phone': '208-489-4326'}, {'name': 'Warren Gude', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Luke's Wound and Hyperbaric Center", 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '61032', 'city': 'Freeport', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Casey Euell, RN', 'role': 'CONTACT', 'email': 'Ceuell1@fhn.org', 'phone': '815-599-7410'}], 'facility': 'The Center for Wound Healing at FHN', 'geoPoint': {'lat': 42.29669, 'lon': -89.62123}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathryne Beasley', 'role': 'CONTACT', 'email': 'kbeasley@tuftsmedicalcenter.org', 'phone': '617-636-5287'}, {'name': 'Geneve Allison, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tufts Medical Center - Center for Wound Healing', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48341', 'city': 'Pontiac', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Cardwell, RN', 'role': 'CONTACT', 'phone': '248-858-2606'}], 'facility': 'St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine', 'geoPoint': {'lat': 42.63892, 'lon': -83.29105}}, {'zip': '12742', 'city': 'Harris', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Johnston', 'role': 'CONTACT', 'email': 'jennifer.johnston@restorixhealth.com', 'phone': '845-794-4620'}], 'facility': 'Catskill Regional Medical Center - Wound Healing Center', 'geoPoint': {'lat': 41.71426, 'lon': -74.72627}}, {'zip': '10940', 'city': 'Middletown', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Hinson', 'role': 'CONTACT', 'email': 'jessica.hinson@restorixhealth.com', 'phone': '845-333-7706'}, {'name': 'Inocencia Carrano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orange Regional', 'geoPoint': {'lat': 41.44593, 'lon': -74.42293}}, {'zip': '14301', 'city': 'Niagara Falls', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cassandra Laflair, RN', 'role': 'CONTACT', 'phone': '716-278-4424'}], 'facility': 'The Wound Center of Niagara', 'geoPoint': {'lat': 43.0945, 'lon': -79.05671}}, {'zip': '28546', 'city': 'Jacksonville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brandi Moore', 'role': 'CONTACT', 'email': 'brandi.moore@restorixhealth.com', 'phone': '910-577-4977'}], 'facility': 'Onslow Memorial Hospital - Wound Care and Hyperbaric Center', 'geoPoint': {'lat': 34.75405, 'lon': -77.43024}}, {'zip': '19013', 'city': 'Chester', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Barrett, DPM', 'role': 'CONTACT', 'email': 'christopher.barrett@restorixhealth.com', 'phone': '610-619-8400'}], 'facility': 'The Center for Wound Healing Crozer Chester Medical Center', 'geoPoint': {'lat': 39.84753, 'lon': -75.35785}}, {'zip': '19047', 'city': 'Langhorne', 'state': 'Pennsylvania', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Aria Health Bucks Wound Center', 'geoPoint': {'lat': 40.17455, 'lon': -74.92267}}, {'zip': '19124', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Aria Health Frankford Wound Care Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Shafer', 'role': 'CONTACT', 'email': 'rachel.shafer@restorixhealth.com', 'phone': '713-242-4325'}], 'facility': 'Memorial Hermann Memorial City', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine Stubbs', 'role': 'CONTACT', 'email': 'katherine.stubbs@memorialhermann.org', 'phone': '713-456-6100'}], 'facility': 'Memorial Hermann South West', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77089', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eber Lopez', 'role': 'CONTACT', 'email': 'eber.lopez@memorialhermann.org', 'phone': '832-658-5100'}], 'facility': 'Memorial Hermann South East', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77450', 'city': 'Katy', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamey Rush', 'role': 'CONTACT', 'email': 'jamey.rush@memorialhermann.org', 'phone': '281-579-5542'}], 'facility': 'Memorial Hermann Katy Rehab', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '25702', 'city': 'Huntington', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sabrina Briggs, RN', 'role': 'CONTACT', 'phone': '304-399-7450'}], 'facility': "St. Mary's Wound and Hyperbaric Center", 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}, {'zip': '25703', 'city': 'Huntington', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brandi Dillon, RN', 'role': 'CONTACT', 'phone': '304-399-3510'}], 'facility': 'The Center for Wound Healing Cabell Huntington Hospital', 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}], 'centralContacts': [{'name': 'Stacy Gardner', 'role': 'CONTACT', 'email': 'sgardner@nuot.com', 'phone': '240-406-1816'}], 'overallOfficials': [{'name': 'Peter Clausen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nuo Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nuo Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}