Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
Study NCT ID:
NCT01912092
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2013-07-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Askina Calgitrol Paste Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-30', 'studyFirstSubmitDate': '2013-07-25', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical signs of local infection (Presence of erythema, pain, tenderness, warmth or induration)', 'timeFrame': 'At day 0, day 2 and weekly in a period of a maximum of 6 weeks', 'description': 'During each of the day 2 and weekly control visits, the investigator will observe the wound visually and assess it for signs of Clinical infection, using the Guidelines for Diabetic Foot Ulcer infection of the Infectious Diseases Society of America. The investigator will score the degree of infection of the wound according to a table adapted from the 8 items wound score for diabetic foot infections.\n\nIn general, treatment with Askina Calgitrol Paste will be discontinued when local infection has resolved or when it was worsened since the last control visit. However, treatment of Askina Calgitrol Paste will continued after 4 weeks of treatment only if there are signs of improvement.\n\nThe treatment period of Askina Calgitrol Paste will last a maximum of 6 weeks.'}], 'secondaryOutcomes': [{'measure': 'Adverse events or Adverse device related event', 'timeFrame': 'At day 2 and weekly in a period of a maximum of 6 weeks'}, {'measure': 'Evaluation of wound bed (necrosis, slough, granulation, epithelialisation)', 'timeFrame': 'At day 0, day 2 and weekly in a period of a maximum of 6 weeks', 'description': 'It will be assessed visually by the investigator.'}, {'measure': 'Ease of use of Askina Calgitrol Paste', 'timeFrame': 'Daily or at every change of dressing, in a period of a maximum of 6 weeks', 'description': "Ease of application and removal of dressing will be assessed by the subject/subject's relatives and the investigator using a rating scale of 1 (very easy) to 5 (very difficult). Dressing change at home will be evaluated in a patient diary by the patient or the carer and dressing changes in the clinic by the investigator."}, {'measure': 'Wound surface area', 'timeFrame': 'At day 0, day 2 and weekly in a period of a maximum of 6 weeks', 'description': 'It will be measured by Visitrak Wound Measurement System at each clinic visit by the healthcare professional.'}]}, 'conditionsModule': {'conditions': ['Diabetic Foot Ulcer (DFU)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of Askina® Calgitrol® Paste in reducing local infection in subjects treated for mildly infected Diabetic Foot Ulcers (DFU) with Askina® Calgitrol® Paste.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject older than 18 years old\n* Provision of written consent by the subject themselves\n* Subjects with a Texas stage I-B wound below the malleolus: superficial and infected (Wagner-Armstrong classification system).\n* Subjects with a mildly infected wound according to the Infectious Diseases Society of America (IDSA).\n* Size of wound \\>2 cm2.\n* Absence of ischaemia of the lower limb as assessed by :\n\n 1. Transcutaneous oxygen pressure (TcPO2) \\> 30 mmHg.\n 2. Toe pressure \\> 50 mmHg.\n 3. Ankle pressure \\> 70 mmHg.\n* Capable of following Study instructions.\n* Compliant with treatment and in particular with off-loading regime.\n* Stable management of their diabetes as defined by an HbA1C (%) of 12%\n\nExclusion Criteria:\n\n* Subjects who are \\<18 years old.\n* Subjects with a documented sensitivity to alginates or silver.\n* Subjects taking a medication or using a device comprising silver.\n* Subjects already taking antibiotics before enrolment\n* Subjects undergoing dialysis.\n* Subjects using therapy known to be immune-compromising such as systemic anti-neoplastic drugs and/or systemic cortico-steriods.\n* Pregnancy\n* Breast-feeding\n* Currently participating in another clinical trial, or who have participated in another clinical trial in the last 6 weeks or who have previously taken part in this study'}, 'identificationModule': {'nctId': 'NCT01912092', 'briefTitle': 'Askina Calgitrol Paste Diabetic Foot Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'BBraun Medical SAS'}, 'officialTitle': 'A NON-CONTROLLED PROSPECTIVE COHORT STUDY OF THE USE OF ASKINA® CALGITROL® PASTE + STANDARD OF CARE ON MILDLY INFECTED, NON-ISCHAEMIC DIABETIC FOOT ULCERS', 'orgStudyIdInfo': {'id': 'OPM-O-H-1205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Askina Calgitrol Paste', 'interventionNames': ['Device: Askina Calgitrol paste']}], 'interventions': [{'name': 'Askina Calgitrol paste', 'type': 'DEVICE', 'armGroupLabels': ['Askina Calgitrol Paste']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Diabetic Foot and metabolic diseases clinic', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Casa di Cura MultiMedica', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BBraun Medical SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}