Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT02360358
Status:
TERMINATED
Last Update Posted:
2016-01-07
First Post:
2015-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Skin Substitute for Chronic Leg/Foot 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'slow inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-06', 'studyFirstSubmitDate': '2015-01-29', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with complete wound closure after 26 weeks.', 'timeFrame': '26 weeks', 'description': 'The primary objective of this study is to demonstrate the superiority of Tiscover® compared to AS210 for achieving wound healing in subjects with a chronic (arterio) venous leg or foot ulcer.'}], 'secondaryOutcomes': [{'measure': 'Time in days to complete wound closure from baseline.', 'timeFrame': '12 weeks'}, {'measure': '• Proportion of subjects with complete wound closure at each of the 12 treatment weeks.', 'timeFrame': '12 weeks'}, {'measure': 'Percentage of wound closure', 'timeFrame': '12 and 26 weeks'}, {'measure': 'Proportion of subjects with durable wound healing over the 3 months following complete wound closure', 'timeFrame': '3 months and 6 months follow up'}, {'measure': 'Wound size reduction', 'timeFrame': '12 and 26 weeks', 'description': 'The percentage of reduction in wound area'}, {'measure': 'Pain', 'timeFrame': 'week 0, 1,2,4,8,12, 26 weeks and follow up', 'description': 'Measured with VAS Pain scale'}, {'measure': 'Quality of Life', 'timeFrame': 'Week 0, 12, 26 weeks and follow up', 'description': 'Measured with SF 36'}, {'measure': 'Number of SAE', 'timeFrame': '12, 26 weeks and follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Varicose Ulcer']}, 'descriptionModule': {'briefSummary': 'A prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group) or with AS210 (control group) to determine the safety and relative efficacy of both products.', 'detailedDescription': 'Multicenter, randomised clinical trial in out patient in which patients with chronic (arterio-) venous leg/foot ulcers are treated with an autologous cultured human living skin substitute (Tiscover®: test group) or with Acellular donor dermis (AS210: control group). During a pre-inclusion evaluation period of 4 weeks (non healing) chronicity of ulcer is ensured (ulcer size change of \\< 30%). To determine ulcer type ABI, Doppler and CEAP is performed.\n\nThe test group will receive 2 applications of Tiscover®. Week 0: wound activating pre-treatment, application of at least one quarter of the wound surface. Week 1: removal of patches, application of patches on total wound surface.\n\nThe control group (16 patients) will follow the same application protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Have a (arterio) venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), or on foot (not plantar side of the foot) with a surface area ≥ 1.0 cm2 and ≤ 40.0 cm2\n* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.\n* Arterial supply adequacy confirmed (ABPI ≥ 0.6 and ≤ 1.3)\n* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone. Ulcer depth \\< 1 cm\n* Target ulcer duration ≥ 12 weeks but ≤ 15 years\n* Acceptable state of health and nutrition\n* Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations\n\nExclusion Criteria:\n\n* History of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin.\n* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.\n* A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).\n* Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.\n* Refusal of or inability to tolerate compression therapy.\n* Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.\n* History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).\n* \\>30% change of wound size in 4 weeks or confirmed by historical data\n* Presence of deep vein thrombosis or contra indication for compression therapy\n* Severe co-morbidity reducing life expectance to \\< 1 year\n* Use of oral corticosteroids and/or cytostatics \\>20 mg/per day;\n* Severe infection of ulcer, active cellulitis, osteomyelitis\n* Severe malnutrition\n* Uncontrolled diabetes mellitus, HbA1c \\> 12% (108 mmol/mol)\n* Anaemia Hb \\<6 mmol/l'}, 'identificationModule': {'nctId': 'NCT02360358', 'briefTitle': 'Autologous Skin Substitute for Chronic Leg/Foot Ulcers.', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'A Phase II Randomized Multicenter Study on Efficacy and Safety of Cultured Autologous Skin (Tiscover®) and Acellular Dermal Matrix (AS210) in Chronic (Arterio-)Venous Ulcers', 'orgStudyIdInfo': {'id': 'TIS2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'autologous cultured skin', 'description': 'autologous cultured skin patches (Tiscover) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size. Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new Tiscover patches.', 'interventionNames': ['Drug: Tiscover']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'acellular donor dermis', 'description': 'acellular donor dermis (AS210) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size.\n\nApplication week 0 is removed after one week (week1). Week 1: wound is completely covered with new AS210 patches.', 'interventionNames': ['Other: AS210']}], 'interventions': [{'name': 'Tiscover', 'type': 'DRUG', 'otherNames': ['autologous skin substitute'], 'description': 'two step procedure, week 0 and week1. Dosage depends on wound size.', 'armGroupLabels': ['autologous cultured skin']}, {'name': 'AS210', 'type': 'OTHER', 'otherNames': ['Acellular donor dermis'], 'description': 'two step procedure, week 0 and week1. Dosage depends on wound size.', 'armGroupLabels': ['acellular donor dermis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1817 MS', 'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Centrum Oosterwal', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Almere Stad', 'country': 'Netherlands', 'facility': 'Flevo Ziekenhuis, afdeling dermatologie', 'geoPoint': {'lat': 52.37025, 'lon': 5.21413}}, {'zip': '1081HZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University Medical center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'St. Fransiscus Gasthuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Ziekenhuis, dermatologie', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Susan Gibss, Prof.dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'VU medical center, department of dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chantal Blok', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'trial coordinator', 'investigatorFullName': 'Chantal Blok', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}