Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-29 @ 9:10 AM
Study NCT ID:
NCT05762432
Status:
RECRUITING
Last Update Posted:
2024-08-21
First Post:
2023-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetic Foot Ulcer Research Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D016523', 'term': 'Foot Ulcer'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001458', 'term': 'Bandages'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Subjects will be randomised 1:1 to RTD Wound Dressing or standard of care dressing. Randomisation will be in blocks of four.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Combination of normal standard of care and study device'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of Wound Healing', 'timeFrame': '12 weeks', 'description': '100% epithelialised'}, {'measure': 'Reduction in Wound Area', 'timeFrame': '12 weeks', 'description': '% reduction in size of Wound Area'}], 'secondaryOutcomes': [{'measure': 'Wound Infection Rates', 'timeFrame': '12 weeks', 'description': 'Rates at which the wound is infected'}, {'measure': 'Dressing Changes', 'timeFrame': '12 weeks', 'description': 'Number of dressing changes required per week and in total'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Foot Ulcer', 'Diabetic Foot Ulcer'], 'conditions': ['Diabetic Foot Ulcer', 'Diabetic Foot Ulcer Neuropathic', 'Diabetic Foot Ulcer Ischemic']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare safety and performance of the study device to the current typical NHS standards of care device. The main outcomes it aims to achieve are:\n\nComplete wound healing at 12 weeks (100% epithelialised)\n\n% Reduction in wound area at 12 weeks\n\nParticipants will attend their NHS podiatry clinic appointment as normal and will be assigned either the study device or the current typical NHS standard of care device. Researchers will compare the study device group to the standard group to assess the outcomes mentioned previously.', 'detailedDescription': 'The purpose of this clinical trial is to evaluate the safety and performance of the RTD Wound Dressing in the treatment of non-infected neuropathic, ischaemic, and neuro-ischaemic diabetic foot ulcers versus standard of care.\n\nThis clinical evaluation study will be performed under an open-label, comparative, design in the single health board of NHS Lanarkshire within 3 diabetic foot clinics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged ≥18 years old with a diagnosis of type 1 or type 2 diabetes.\n* New presentation for treatment of a neuropathic, ischaemic or neuro- ischaemic non- infected DFU\n* Subjects must be able to follow verbal and written instructions in English\n* Subjects must have full mental capacity and able to give written informed consent to participation in the trial including medical photography for the purposes of the clinical trial or clinical care.\n* DFU is \\>10mm2 and \\<100mm2\n\nExclusion Criteria:\n\n* Known allergy/hypersensitivity to any ingredient contained in the Keneric healthcare RTD Wound Dressing\n* Participants who will have problems following the protocol, including the offloading system, provided as standard of care, to wear on a daily basis\n* Suspected malignancy in the wound\n* Critical limb ischaemia\n* Pregnant or breastfeeding females\n* Women of childbearing potential and not using a medically accepted form of contraception when sexually active.'}, 'identificationModule': {'nctId': 'NCT05762432', 'briefTitle': 'Diabetic Foot Ulcer Research Study', 'organization': {'class': 'OTHER', 'fullName': 'Community Pharmacology Services Ltd'}, 'officialTitle': 'A Pilot Open Label Prospective, Randomised, Study to Evaluate the Safety and Efficacy of Keneric Healthcare RTD Wound Dressing in the Treatment of Diabetic Foot Ulcers Compared to Standard of Care', 'orgStudyIdInfo': {'id': 'CPS22.007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Device', 'description': "This Arm of the study will receive the study device. Although the Study Device is not experimental as it is already CE marked and being used for it's intended purpose.", 'interventionNames': ['Device: Wound Dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': "This arm of the study will use the NHS' existing standard of care device as is normally used in podiatry clinics.", 'interventionNames': ['Device: NHS Standard Dressing']}], 'interventions': [{'name': 'Wound Dressing', 'type': 'DEVICE', 'description': 'RTD Wound Dressing that is being investigated', 'armGroupLabels': ['Study Device']}, {'name': 'NHS Standard Dressing', 'type': 'DEVICE', 'description': 'This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ML6 0JS', 'city': 'Airdrie', 'state': 'North Lanarkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Kaye McIntyre', 'role': 'CONTACT', 'phone': '01236 748 748'}], 'facility': 'NHS Lanarkshire', 'geoPoint': {'lat': 55.86602, 'lon': -3.98025}}, {'zip': 'EH54 6PP', 'city': 'Livingston', 'state': 'West Lothian', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Chris Jones', 'role': 'CONTACT', 'phone': '01506 523 000'}], 'facility': 'NHS Lothian', 'geoPoint': {'lat': 55.90288, 'lon': -3.52261}}], 'centralContacts': [{'name': 'Duncan Stang, MChS', 'role': 'CONTACT', 'email': 'duncan.stang@lanarkshire.scot.nhs.uk', 'phone': '07554333493'}, {'name': 'Kaye McIntyre, MsC', 'role': 'CONTACT', 'email': 'Kaye.McIntyre@lanarkshire.scot.nhs.uk', 'phone': '01236 748748'}], 'overallOfficials': [{'name': 'Kaye McIntyre, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Lanarkshire'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Community Pharmacology Services Ltd', 'class': 'OTHER'}, 'collaborators': [{'name': 'Keneric Healthcare', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}