Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
Study NCT ID:
NCT06652360
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2024-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemical Debridement and Leg Ulcers
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2024-10-18', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound surface', 'timeFrame': '12 weeks', 'description': 'Change in wound surface area (cm\\^2)'}, {'measure': 'Wound Debris', 'timeFrame': '12 weeks', 'description': 'Change in the percentage of the wound bed covered with slough'}], 'secondaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': '12 weeks', 'description': 'Number of healed wounds, according BWAT score ranging from 13 (minimal) - 65 (extreme severity)'}, {'measure': 'wound condition', 'timeFrame': '12 weeks', 'description': 'Condition of the wound bed by percentage of granulation tissue, percentage covered in slough, exudate; Measured via visual assessment totalling up to 100% (e.g. 30% granulation, 25% slough, 25% necrosis, 20% exudate)'}, {'measure': 'Quality of Life', 'timeFrame': '12 weeks', 'description': 'Health-related quality of life assessed using WoundQOL (an established validated questionair production a single number between 0-1 with 1 being the optimal quality of life)'}, {'measure': 'Patient Comfort in treatment process', 'timeFrame': '12 weeks', 'description': 'Pain measured Participant pain measured using Visual Analogue Scale (VAS 0-10, 0 being painless and 10 being most pain to be imagined)'}, {'measure': 'Device Safety', 'timeFrame': '12 weeks', 'description': 'Incidence of Treatment-related Adverse Events Incidence of Adverse Events of Special Interest'}, {'measure': 'Treatment Comfort in performance and acceptance', 'timeFrame': '12 weeks', 'description': 'Participant and staff acceptance of the debridement methods by questionnaire. Score denoted in precentage with 100% being fully comfortable and accepted.'}, {'measure': 'wound condition', 'timeFrame': '12 weeks', 'description': 'Condition of peri-ulcer skin and surrounding skin (healthy, bumpy, integrated, fragile))'}, {'measure': 'wound condition', 'timeFrame': '12 weeks', 'description': 'Maloudour (yes, no);'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chemical debridement', 'mechanical debridement', 'topical dessicating agent', 'venous leg ulcer', 'chronic wound'], 'conditions': ['Venous Leg Ulcers', 'Mixed Ulcer']}, 'descriptionModule': {'briefSummary': 'A pilot study to investigate the relative effectiveness and safety of chemical wound debridement and curettage in the treatment of venous and mixed aetiology leg ulcers.', 'detailedDescription': 'A pilot study to investigate the relative effectiveness and safety of chemical wound debridement versus the curettage wound debridement in the treatment of venous and mixed aetiology leg ulcers in the United Kingdom'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with a venous leg ulcer or mixed aetiology ulcer.\n* Duration of wound ≥ 6 weeks ≤ 5 years\n* Wound is ≥ 5 cm2 ≤ 200cm2\n* Presence of at least 25% visible slough within the wound bed\n* The Participant must be able to understand the study and provide written informed consent\n* No clinical signs of infection\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindications to any of the wound treatments, dressings or compression bandaging to be used in the trial\n* Current local or systemic antibiotics in the week prior to inclusion\n* Clinically infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema\n* Prolonged treatment with immunosuppressive agents or high dose corticosteroids\n* Participants who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)\n* Participants who have participated in a clinical trial on wound healing within the past month\n* Participants with a known history of non- adherence with medical treatment'}, 'identificationModule': {'nctId': 'NCT06652360', 'briefTitle': 'Chemical Debridement and Leg Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'DEBx Medical B.V.'}, 'officialTitle': 'A Pilot Study to Investigate the Relative Effectiveness and Safety of Chemical Wound Debridement and Curettage in the Treatment of Venous and Mixed Aetiology Leg Ulcers.', 'orgStudyIdInfo': {'id': 'DCHEM2023_VLU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chemical Debridement', 'description': '1 single treatment of chemical debridement will be applied in this arm at initiation visit. No repeated treatment done in this trial', 'interventionNames': ['Device: Chemical Debridement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sharp debridement', 'description': 'In the control arm wound debridement by curettage will be performed at initiation visit and after 2 weeks when clinician deems this necessary, conform standard of care protocol', 'interventionNames': ['Device: Curettage debridement']}], 'interventions': [{'name': 'Chemical Debridement', 'type': 'DEVICE', 'description': 'The chemical debridement is a dehydrating agent in a gel shape that will dry out the woundbed and biofilm.', 'armGroupLabels': ['Chemical Debridement']}, {'name': 'Curettage debridement', 'type': 'DEVICE', 'description': 'The use of a currette will clean the wound bed. Debridement by mechanically removing the necrotic tissue and biofilm. This is performed confrom the standard of care standards.', 'armGroupLabels': ['Sharp debridement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Eastbourne', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'David Gray, MSc', 'role': 'CONTACT', 'email': 'Georgina.Sutherland@pioneer-whlc.org', 'phone': '+44 (0)7584 374 316'}], 'facility': 'Pioneer wound healing and lymphedema centres', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}], 'centralContacts': [{'name': 'Johannes Snels, MSc', 'role': 'CONTACT', 'email': 'info@debx-medical.com', 'phone': '+31 639084549'}, {'name': 'Bert Quint, PhD', 'role': 'CONTACT', 'email': 'info@debx-medical.com', 'phone': '+31 85 0878096'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DEBx Medical B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}