Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT04667416
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2020-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone with treatment-emergent adverse events (TEAEs)', 'timeFrame': 'All adverse events (AEs) and serious adverse events (SAEs) will be recorded from the time of signing of the informed consent form through Week 64.', 'description': 'Treatment-emergent adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) and graded per the CTCAE Version 5.0.'}, {'measure': 'Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone who achieve complete ulcer closure by Week 12.', 'timeFrame': 'BWAT assessment and wound imaging will be performed at each study visit through end of treatment (Week 12)', 'description': 'Complete wound closure will be assessed by the Bates-Jensen Wound Assessment Tool (BWAT) and a photographic imaging and measurement device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic ulcer', 'Venous stasis ulcer'], 'conditions': ['Chronic Ulcer of Lower Extremity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able to read, understand and sign the informed consent form (ICF)\n* Available and willing to complete all study assessments\n* At least 12 weeks post lower extremity revascularization procedure, if one has been performed\n* Have chronic ulcer(s) of the lower extremities with the following characteristics:\n\n * Of diabetic or vascular etiology\n * Duration of ≥4 weeks, unresponsive to SOC\n * ≤20 cm2 in area\n * Extend through the full thickness of the skin but not down to muscle, tendon, or bone\n* For subjects with VLU:\n\n * Ulcer area is ≥1.5 cm2 and ≤20 cm2 and with a clean, granulating base with minimal adherent slough\n * Ulcer location is at or above the ankle (malleolus) and below the knee\n * Ulcer location is appropriate for use of compression therapy treatment\n* For subjects with DFU:\n\n * Ulcer area is ≥1.5 cm2 and ≤ 20 cm2 and is amenable to off-loading\n * Subject has diabetes mellitus (Type 1 or Type 2), requiring insulin or oral/injectable medications to control blood glucose levels\n * Glycosylated hemoglobin (HbA1c) level at screening is \\<12%\n* Adequate circulation to the affected lower extremities\n* Total serum bilirubin, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), hemoglobin, WBC, and PLT count all within limits specified in study protocol\n* No renal impairment or mild renal impairment, defined as creatinine clearance ≥50 mL/min (by Cockroft-Gault estimation)\n* Male subjects and female subjects of childbearing potential must use acceptable methods of contraception\n\nExclusion Criteria:\n\n* Clinical evidence of ongoing infection and/or receipt of IV, oral, or topical antimicrobials at the Baseline Visit\n* Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable)\n* Ulceration at the site of amputation\n* Undergoing renal dialysis\n* Known or suspected malignancy in the target ulcer, or a history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer)\n* Documented history of osteomyelitis at the target ulcer location within 6 months of screening\n* Current treatment or anticipated need for treatment over the course of the study with:\n\n * Immunosuppressants (including topical or systemic corticosteroids or glucocorticoids)\n * Cytotoxic chemotherapy\n * Growth hormone\n * Oral or systemic antifungal or antituberculosis treatment\n* History of radiation at the ulcer site\n* New York Heart Association Class III or IV congestive heart failure or uncontrolled cardiac dysrhythmia\n* Diagnosis of autoimmune disease(s) (rheumatoid arthritis, lupus, psoriasis, Sjogren's syndrome) or arthritis requiring corticosteroid treatment\n* Target ulcer(s) previously treated with negative pressure, hyperbaric oxygen, or tissue engineered materials (eg, Apligraf®, EpiFix® or Dermagraft®) or other scaffold materials (eg, Oasis, Matristem) within 4 weeks prior to Screening Visit\n* Target ulcer(s) anticipated to require negative pressure wound therapy or hyperbaric oxygen at any time during the study\n* Subjects with VLU who have:\n\n * Deep vein thrombosis diagnosed within 4 weeks prior to Screening Visit\n * Refusal or inability to tolerate compression therapy\n* Subjects with DFU who have:\n\n * Active Charcot foot (stable chronic Charcot foot is not exclusionary)\n * Ulcers on toes 2, 3, 4, and/or 5 only (ulcer on plantar surface of the great toe only is not exclusionary)\n* Pregnant or breast feeding\n* Allergic to DMSO\n* Healing of target ulcer is observed to be ≥35% at the end of the Run-in Period (between Screening and Baseline Visits)\n* Presence of any condition(s) which compromises the subject's ability to complete this study, including subjects with a known history of poor adherence to medical treatment\n* Subjects who, in the opinion of the Investigator, are not able to comply with study requirements\n* Treatment with an investigational drug(s) or device(s) within the 4 weeks preceding Screening"}, 'identificationModule': {'nctId': 'NCT04667416', 'briefTitle': 'Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amnio Technology, LLC'}, 'officialTitle': 'A Prospective, Multicenter, Randomized, Controlled Clinical Investigation of PalinGen® Flow Amniotic Tissue Allograft to Assess Safety, Tolerability, and Preliminary Efficacy for the Treatment of Chronic Lower Extremity Cutaneous Ulcers Compared to Standard of Care', 'orgStudyIdInfo': {'id': 'PGF-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care (SOC)', 'description': 'Participants will receive SOC for chronic ulcers of the lower extremities.'}, {'type': 'EXPERIMENTAL', 'label': 'PalinGen Flow Treatment plus SOC', 'description': 'Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC.', 'interventionNames': ['Biological: PalinGen Flow Amniotic Tissue Allograft']}], 'interventions': [{'name': 'PalinGen Flow Amniotic Tissue Allograft', 'type': 'BIOLOGICAL', 'description': 'Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC.', 'armGroupLabels': ['PalinGen Flow Treatment plus SOC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Center for Clinical Research', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'Center for Clinical Research', 'geoPoint': {'lat': 37.6941, 'lon': -122.08635}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Limb Preservation Platform', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Center for Clinical Research', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'ILD Research Center', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Acclaim Bone & Joint Institute and Plastic Surgery', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78501', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Futuro Clinical Trials', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}], 'overallOfficials': [{'name': 'Joseph M Caporusso, D.P.M.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Futuro Clinical Trials'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amnio Technology, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}