Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-09 @ 1:02 PM
Study NCT ID:
NCT02845466
Status:
UNKNOWN
Last Update Posted:
2018-04-09
First Post:
2016-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}, {'id': 'D017719', 'term': 'Diabetic Foot'}], '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'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077214', 'term': 'Becaplermin'}], 'ancestors': [{'id': 'D020574', 'term': 'Proto-Oncogene Proteins c-sis'}, {'id': 'D010982', 'term': 'Platelet-Derived Growth Factor'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D004268', 'term': 'DNA-Binding Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-06', 'studyFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Applied Growth Factors in Chronic Wound Fluid', 'timeFrame': '6 weeks', 'description': 'The levels of the growth factors applied to the chronic wound will be measured using samples of the wound fluid gathered at the first two visits each week.'}], 'secondaryOutcomes': [{'measure': 'Protease Levels in Chronic Wound Fluid', 'timeFrame': '6 weeks', 'description': 'The levels of enzyme activity in the chronic wound will be measured using samples of the wound fluid gathered at the first two visits each week.'}, {'measure': 'Chronic Wound Healing at 4 Weeks', 'timeFrame': '4 weeks', 'description': 'Chronic wound healing will be measured using the VISITRAK device, which traces the outline of the chronic wound.'}, {'measure': 'WOUNDCHEK Device Validity', 'timeFrame': '6 weeks', 'description': 'The WOUNDCHEK device will be used in order to test for levels of enzyme activity in the chronic wound. This data will then be compared to the enzyme activity as determined by the levels analyzed in the chronic wound fluid.'}, {'measure': 'Levels of Healing Biomarkers in Chronic Wound Fluid', 'timeFrame': '6 weeks', 'description': 'The levels of the potential biomarker of healing GMCSF in the chronic wound fluid will be measured using samples of the chronic wound fluid collected at the first two visits each week.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Venous Leg Ulcer', 'Diabetic Foot Ulcer', 'Wound Healing', 'Growth Factor', 'Protease Inhibitor'], 'conditions': ['Venous Ulcer', 'Foot Ulcer, Diabetic']}, 'referencesModule': {'references': [{'pmid': '29703712', 'type': 'DERIVED', 'citation': 'Stacey M. Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing: Protocol for a Randomized Controlled Proof-of-Concept Study. JMIR Res Protoc. 2018 Apr 27;7(4):e97. doi: 10.2196/resprot.8327.'}]}, 'descriptionModule': {'briefSummary': 'Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged ≥18 years\n* Ulcer size 1-64 cm²\n* Ulcer extends through both the epidermis and dermis, with no exposed tendon or bone\n* Ulcer duration \\>3 months\n* Ulcer located between and including the knee and ankle\n* For venous leg ulcers - Venous refilling time \\<25s on photoplethysmography or abnormal venous insufficiency Duplex scan\n* For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a haemoglobin A1C \\< 12%\n* Wounds have not been treated with Promogran in the previous 4 weeks\n* Patients able to give informed consent\n\nExclusion Criteria:\n\n* Ankle-brachial index \\<0.8\n* Ulcer with local or systemic signs of infection\n* Patients who have been previously treated with Becaplermin gel\n* Receiving corticosteroids or immune suppressants\n* History of autoimmune disease\n* Uncontrolled diabetes (baseline haemoglobin A1C \\> 12%)\n* Severe rheumatoid arthritis\n* Uncontrolled congestive heart failure\n* Malnutrition (albumin \\<2.5g/dL)\n* Unable to adhere to the protocol\n* Known sensitivities to the wound dressings used in the trial\n* A history of any previous malignancy\n* pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT02845466', 'briefTitle': 'Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Proof of Concept Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing', 'orgStudyIdInfo': {'id': 'Lower Limb Ulcer Topical Ther'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Becaplermin/Promagran Dressing', 'description': 'Topical Becaplermin with a protease inhibitor wound dressing.', 'interventionNames': ['Biological: Becaplermin', 'Device: Promagran Dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Becaplermin/Placebo Dressing', 'description': 'Topical Becaplermin with a placebo wound dressing.', 'interventionNames': ['Biological: Becaplermin', 'Device: Placebo Dressing']}], 'interventions': [{'name': 'Becaplermin', 'type': 'BIOLOGICAL', 'otherNames': ['Regranex'], 'description': '0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks.', 'armGroupLabels': ['Becaplermin/Placebo Dressing', 'Becaplermin/Promagran Dressing']}, {'name': 'Promagran Dressing', 'type': 'DEVICE', 'description': '44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks.', 'armGroupLabels': ['Becaplermin/Promagran Dressing']}, {'name': 'Placebo Dressing', 'type': 'DEVICE', 'otherNames': ['Aquacel'], 'description': 'Inactive wound dressing.', 'armGroupLabels': ['Becaplermin/Placebo Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Steve Phillips, MSc', 'role': 'CONTACT', 'email': 'phills3@mcmaster.ca', 'phone': '905-521-2100', 'phoneExt': '44167'}], 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Steve Phillips, MSc', 'role': 'CONTACT', 'email': 'phills3@mcmaster.ca', 'phone': '905-521-2100', 'phoneExt': '44167'}], 'overallOfficials': [{'name': 'Michael Stacey, MBBS, Doctor of Surgery', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}