Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:42 AM
Study NCT ID:
NCT07438951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing in the Treatment of Diabetes Related Foot Ulcers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage area reduction', 'timeFrame': 'at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence of wound closure', 'timeFrame': 'at 12 weeks'}, {'measure': 'Percentage area reduction', 'timeFrame': 'at 4 weeks'}, {'measure': 'Incidence of >50% percentage area reduction', 'timeFrame': 'at 4 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic foot ulcers', 'Nitric Oxide', 'Wound', 'dressing', 'Woundcare'], 'conditions': ['Diabetic Foot Ulcers (DFUs)']}, 'descriptionModule': {'briefSummary': 'Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects over the age of 18 years with a non-healing DFU (defined as failing to progress on a healing trajectory in the previous 4 weeks prior to enrolment) and treated with ConvaNiox (EDX110) will be screened for eligibility based on medical record review and discussions with the subject and their treating physician.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIC-1 - Subjects at least 18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study\n\nIC-2 - The subject must have either type 1 or type 2 diabetes and a diabetes-related ulcer meeting all the following characteristics:\n\nIC-2a Classified as University of Texas (UT) Classification Grade 1 stages A-D IC-2b At or below the level of malleolus IC-2c Neuropathic or neuroischemic etiology confirmed through Electronic Medical Records (EMR) IC-2d Ulcer surface area between ≥1 and ≤25 cm² IC-2e For subjects who have more than one ulcer, the largest ulcer will be the study ulcer\n\nIC-3 Non-infected and infected ulcers are eligible for inclusion, with infection being classified using the International Working Group on the Diabetic Foot (IWGDF) Infection guidelines.\n\nOnly PEDIS 2 infections are permitted - Mild superficial skin and soft tissue infections with no systemic manifestations and involving:\n\n• Erythema extending ≥2 cm from the wound margin, and/or tissue deeper than skin and subcutaneous tissues (e.g., tendon, muscle, joint, and bone)\n\nIC-4 Adequate arterial supply in the lower extremity as defined by Wound, Ischemia, foot Infection (WIfI) Ischemia grade 0-1;\n\n1. Palpable foot pulse with biphasic or triphasic pedal Doppler waveforms, AND\n2. Ankle Brachial Index (ABI) \\>0.6 OR Toe Brachial Index (TBI) \\>0.5, OR\n3. Toe pressure \\>40mmHg\n\nExclusion Criteria:\n\nEC-1 Ulcers that are tunnelling or have cavities (\\>10mm in depth)\n\nEC-2 An ulcer that is actively bleeding. Subjects may be re-screened once active bleeding has stopped\n\nEC-3 Subjects taking any medication known to inhibit wound closure including chemotherapy and immunomodulatory biological agents. The use of systemic corticosteroids \\<10mg/kg/day is permitted\n\nEC-4 Active Charcot foot'}, 'identificationModule': {'nctId': 'NCT07438951', 'acronym': 'ONWARD', 'briefTitle': 'A Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing in the Treatment of Diabetes Related Foot Ulcers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'ConvaTec Inc.'}, 'officialTitle': 'A Prospective, Multi-Centre, Observational, Real World Evidence Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing (ConvaNiox™) in the Treatment of Diabetes Related Foot Ulcers (DFUs).', 'orgStudyIdInfo': {'id': 'WC-25-465'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with non-healing diabetes-related foot ulcers, treated with ConvaNiox', 'interventionNames': ['Device: ConvaNiox']}], 'interventions': [{'name': 'ConvaNiox', 'type': 'DEVICE', 'description': 'At each visit subjects will receive their Standard of Care (SoC) treatment for their DFU, but instead of their normal primary dressing they will receive an application of ConvaNiox (EDX110).', 'armGroupLabels': ['Subjects with non-healing diabetes-related foot ulcers, treated with ConvaNiox']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrew Thomas', 'role': 'CONTACT', 'email': 'andrew.thomas@convatec.com', 'phone': '+44 (0) 7791904279'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ConvaTec Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}