Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT06918561
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'CROSSOVER', 'interventionModelDescription': 'The subject will be randomized to one of the following treatments:\n\n* Standard of care\n* NeoThelium FT in addition to standard of care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events and Serious Adverse Events', 'timeFrame': 'Day -14 through 91 days', 'description': 'The number and nature of adverse events (AEs) and series adverse events (SAEs) occurring during the study will be tracked and reported.'}, {'measure': 'Follow-Up Closure', 'timeFrame': '2 weeks', 'description': 'Number of wounds remaining closed during the 2-week follow-up'}, {'measure': 'Time to Closure', 'timeFrame': '1-12 weeks', 'description': 'Average number of grafts and/or weeks used to achieve wound closure'}], 'primaryOutcomes': [{'measure': 'Complete Wound Closure', 'timeFrame': '1-12 weeks', 'description': 'The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.'}], 'secondaryOutcomes': [{'measure': 'Percentage Wound Area Change', 'timeFrame': '1-12 weeks', 'description': 'The percentage change in wound area from TV-1 to TV-13 will be measured weekly using digital photographic planimetry and physical examination.'}, {'measure': 'Pain Assessment', 'timeFrame': 'Day 0, Day 14, Day 35, Day 56, Day 84', 'description': 'Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale at designated time points'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic wounds', 'Wound Medicine', 'Cellular, Acellular, Matrix-like Product (CAMP)', 'Cellular and/or Tissue Product (CTP)', 'Dehydrated Complete Human Placental Membrane (dCHPM)'], 'conditions': ['Open Wound']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating chronic open wounds.', '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 NeoThelium FT.\n\nThe 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 cross over to the IP arm (SOC plus NeoThelium FT). Crossover subjects will begin IP arm treatment with weekly NeoThelium FT 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. All subjects will complete two-week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks. Secondary endpoints consist of wound percentage area reduction rates and pain assessment.'}, '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 "other" Open wound\n3. Subject has a chronic open wound 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 chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening\n5. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization\n6. Subject has an Open wound without infection or clinically visible exposed bone\n7. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit\n8. Index ulcer has a maximum depth of 1cm at screening visit 1\n9. The chronic open wound is treated with offloading therapy, if applicable to location, while standing, sitting, and lying down for 14 days prior to randomization\n10. Adequate circulation of wounds located below the knee demonstrated by an ABI of \\>0.7 and \\<1.3, or TBI of \\>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.\n11. Index ulcer is free of infection prior to randomization and during screening phase.\n12. Index ulcer is free of necrotic debris prior to NeoThelium FT application\n13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n14. Index ulcer 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.\n15. Subject is able and willing to follow the protocol requirements\n16. Subject had signed informed consent\n17. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"\n2. Subject has a known life expectancy of \\<1 year\n3. Subject is unable to comply with protocol treatment\n4. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing.\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 product 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. Open wound 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': 'NCT06918561', 'briefTitle': 'Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'NuScience Medical Biologics, LLC'}, 'officialTitle': 'A Randomized Controlled Multisite Crossover Trial Evaluating the Efficacy of NeoThelium FT in the Treatment of "Other" Open Wounds', 'orgStudyIdInfo': {'id': 'HEAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No Intervention: Standard of Care', 'description': 'Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention: NeoThelium FT & Standard of Care', 'description': 'Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading', 'interventionNames': ['Other: NeoThelium FT']}], 'interventions': [{'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading', 'armGroupLabels': ['No Intervention: Standard of Care']}, {'name': 'NeoThelium FT', 'type': 'OTHER', 'description': 'NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.', 'armGroupLabels': ['Intervention: NeoThelium FT & Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70403', 'city': 'Hammond', 'state': 'Louisiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chelsea Smith, RN', 'role': 'CONTACT', 'email': 'Chelsea.smith@medcentris.com'}, {'name': 'Melanie Knox, LPN', 'role': 'CONTACT', 'email': 'Melanie.knox@medcentris.com'}, {'name': 'Chris Keaton, NP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedCentris of Hammond', 'geoPoint': {'lat': 30.50463, 'lon': -90.46293}}, {'zip': '70458', 'city': 'Slidell', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donyille Singletary, RN', 'role': 'CONTACT', 'email': 'Donyille.singletary@medcentris.com', 'phone': '985-602-1215'}, {'name': 'Katie Schloegel, FNP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedCentris of Slidell', 'geoPoint': {'lat': 30.27519, 'lon': -89.78117}}, {'zip': '39540', 'city': "D'Iberville", 'state': 'Mississippi', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Candace Spears, LPN', 'role': 'CONTACT', 'email': 'candace.spears@medcentris.com', 'phone': '228-300-8235'}, {'name': 'Miranda Reeves, FNP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "MedCentris of D'iberville", 'geoPoint': {'lat': 30.42631, 'lon': -88.89086}}], 'centralContacts': [{'name': 'Angelina Ferguson, DNP', 'role': 'CONTACT', 'email': 'info@sygnola.com', 'phone': '(985) 629-4013'}, {'name': 'Sarah Moore, MBE', 'role': 'CONTACT', 'email': 'info@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'}, 'collaborators': [{'name': 'SygNola, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}