Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:50 AM
Study NCT ID:
NCT07335861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The subject will be randomized to one of the following treatments:\n\nStandard of care (SOC) combined with Hyalomatrix or SOC alone.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2026-01-09', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Closure', 'timeFrame': '1-12 weeks', 'description': 'Average number of grafts/weeks used to achieve wound closure'}, {'measure': 'Follow-Up Closure', 'timeFrame': '2 weeks', 'description': 'Number of wounds that re-opened during the 2-week follow-up'}, {'measure': 'Adverse Events and Serious Adverse Events', 'timeFrame': '1-12 weeks', 'description': 'The number and nature of adverse events (AEs) and serious adverse events (SAEs) occurring during the study will be tracked and reported.'}], 'primaryOutcomes': [{'measure': 'Complete Wound Closure', 'timeFrame': '1-12 weeks', 'description': 'The primary endpoint will be the percentage of target wounds that achieve complete wound closure within 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Weekly Percentage Area Reduction', 'timeFrame': '1-12 weeks', 'description': 'The percentage reduction in wound area from 1-12 weeks will be measured weekly using digital photographic planimetry and physical examination.'}, {'measure': 'Pain Assessment', 'timeFrame': '1-14 weeks', 'description': 'Change in pain associated with the target wound will be assessed using the Numeric Pain Rating Scale throughout the study. Numeric Rating on a scale of 0-10. o is No pain and 10 is the worst possible pain.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Venous Leg Ulcer', 'Chronic Wounds']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.', 'detailedDescription': 'This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus Hyalomatrix. The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to crossover to the IP arm (SOC plus Hyalomatrix). Crossover subjects will begin IP arm treatment with weekly Hyalomatrix applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound\n3. Subject has a venous leg ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a venous leg ulcer with a historical wound measurement showing less than 25% healing within 14 days prior to screening\n5. Subject has a venous leg ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization\n6. Subject has a venous leg ulcer without infection or clinically visible exposed bone\n7. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit\n8. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \\>0.7 and \\<1.3, or TBI of \\>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.\n9. Venous Leg Ulcer is being treated with compression therapy for 14 days prior to treatment visit 1\n10. Index wound is free of necrotic debris prior to Hyalomatrix application\n11. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n12. Index wound is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.\n13. Subject is able and willing to follow the protocol requirements\n14. Subject had signed informed consent\n15. If 2 or more wounds are present, the wounds must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity\n2. Subject has a known life expectancy of \\<1 year\n3. Subject is unable to comply with protocol treatment\n4. Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders\n5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n7. Known contraindications to tissue-engineered allograft\n8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n12. Venous leg ulcer with active infection\n13. Wound depth with visible exposed bone\n14. HBOT within 14 days prior to randomization\n15. Revascularization surgery on the index wound leg within 30 days of screening phase\n16. Index wound suspicious of neoplasm in the opinion of the principal investigator'}, 'identificationModule': {'nctId': 'NCT07335861', 'briefTitle': 'Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'NuScience Medical Biologics, LLC'}, 'officialTitle': 'Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers: A Randomized Controlled Multicenter Crossover Trial', 'orgStudyIdInfo': {'id': 'HALO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Wound cleansing, sharps debridement, dressing for moisture balance, and compression therapy', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Hyalomatrix + Standard of Care', 'description': 'Wound cleansing, sharps debridement, Hyalomatrix application, dressing for moisture balance, compression therapy', 'interventionNames': ['Device: Hyalomatrix']}], 'interventions': [{'name': 'Hyalomatrix', 'type': 'DEVICE', 'description': 'Hyalomatrix is a hyaluronic acid-based wound dressing designed for advanced wound therapy.', 'armGroupLabels': ['Hyalomatrix + Standard of Care']}, {'name': 'Standard of Care', 'type': 'OTHER', 'otherNames': ['SOC'], 'description': 'Wound cleansing, Sharps debridement, Dressing for moisture balance, Compression therapy', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sarah Moore', 'role': 'CONTACT', 'email': 'sarah.moore@sygnola.com', 'phone': '985-629-4013'}, {'name': 'Angelina Ferguson', 'role': 'CONTACT', 'email': 'dr.aferguson@sygnola.com', 'phone': '985-629-4013'}], 'overallOfficials': [{'name': 'Angelina Ferguson, DNP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SygNola, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NuScience Medical Biologics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}