Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-02 @ 2:42 AM
Study NCT ID:
NCT04834232
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2020-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-03', 'studyFirstSubmitDate': '2020-09-26', 'studyFirstSubmitQcDate': '2021-04-03', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ulcer healing within 6 months', 'timeFrame': 'baseline', 'description': 'comparing the results of both modalities in recurrent venous ulcer healing'}], 'secondaryOutcomes': [{'measure': 'patency on stents', 'timeFrame': 'baseline', 'description': 'primary assisted patency included those requiring reintervention to maintain patency; and secondary patency was defined as stents that were blocked and successfully reopened.'}, {'measure': 'compliance', 'timeFrame': 'baseline', 'description': 'to anticoagulation in case of stenting, or to elastic stocking in case of compression therapy, using methods that include patient self-reporting and clinical estimates'}, {'measure': 'assessment of venous disability score (VDS)', 'timeFrame': 'baseline', 'description': 'the VDS evaluates the effect of venous disease by quantifying the level of work based disability.\n\nIt is scored on a scale of 0 to 3 (with 0 being the least severe and 3 the most severe), based on the ability to work an 8-hour day with or without provisions for external support.'}, {'measure': 'assessment of venous clinical severity score', 'timeFrame': 'baseline', 'description': 'the score is obtained by imaging vein segments with duplex Doppler or phlebography.\n\nIt includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Ulcer Recurrent']}, 'referencesModule': {'references': [{'pmid': '23433816', 'type': 'BACKGROUND', 'citation': 'Raju S. Best management options for chronic iliac vein stenosis and occlusion. J Vasc Surg. 2013 Apr;57(4):1163-9. doi: 10.1016/j.jvs.2012.11.084. Epub 2013 Feb 20.'}, {'pmid': '29942813', 'type': 'BACKGROUND', 'citation': 'Xie T, Ye J, Rerkasem K, Mani R. The venous ulcer continues to be a clinical challenge: an update. Burns Trauma. 2018 Jun 15;6:18. doi: 10.1186/s41038-018-0119-y. eCollection 2018.'}, {'pmid': '24953000', 'type': 'BACKGROUND', 'citation': 'George R, Verma H, Ram B, Tripathi R. The effect of deep venous stenting on healing of lower limb venous ulcers. Eur J Vasc Endovasc Surg. 2014 Sep;48(3):330-6. doi: 10.1016/j.ejvs.2014.04.031. Epub 2014 Jun 18.'}, {'pmid': '25165679', 'type': 'BACKGROUND', 'citation': 'Nair B. Compression therapy for venous leg ulcers. Indian Dermatol Online J. 2014 Jul;5(3):378-82. doi: 10.4103/2229-5178.137822. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Comparing the result of of iliac vein stenting and compression therapy in management of recurrent venous ulceration.', 'detailedDescription': "Venous ulceration is the most common etiology of lower extremity ulceration, approximately affecting almost 1% of the world's population. although its overall prevalence is relatively low, the refractory nature of venous ulceration increases morbidity, mortality , the patient's quality of life, and have a significant financial burden on the global budget. the primary risk factors are: old age, obesity deep venous thrombosis, phlebitis and previous leg injuries.\n\nIliac vein compression is a prevalent finding in patients with venous system pathology. It has a variety of causes, including May-Turner syndrome, endometriosis, bladder distension, common iliac artery aneurysm or internal iliac artery aneurysm.\n\nvenous compression becomes clinically significant when there's an increase in venous pressure, which in turn causes venous insufficiency. This contributes to the development of a state of chronic venous stasis, which sequentially causes pooling of blood, triggers further capillary damage and activates inflammatory mediators with the end result of venous ulcer development and impaired wound healing.\n\nLocated on bony prominences, venous ulcers are typically shallow, irregular with granulation tissue and fibrin present in their bases. A careful physical examination is required for a proper diagnosis, but he clinical challenge remains in its management, which includes prevention or the treatment of the clinical implications.\n\nTreatment modalities should always be directed to the cause of the ulcer; they can be divided into:\n\n* non invasive management, such as medical therapy, bandaging and dressings.\n* invasive, such as endovascular and surgical techniques."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients fulfilling both the inclusion and the exclusion criteria will be included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* iliac vein compression.\n* competent superficial venous system.\n* isolated iliac vein lesion.\n* patent femoropopliteal segment.\n* ulcers located in the gaiter area.\n* age \\> 12 years\n* patients with ulcers located in the gaiter area, along with the following associated symptoms: leg heaviness, pain, varicose veins, edema, hemosedrin staining, pruritus, venous dermatitis, lipodermatoscelrosis, telangiectasias, corona phlebectatica, atrophie blanche and deformity of the leg.\n\nExclusion Criteria:\n\n* patients with arterial disease in the same limb.\n* patients with history of phlebitis.\n* patients with congenital venous malformation\n* patients with malignancy.\n* patients with raised renal chemistry.\n* patients with skin allergy.\n* diabetic neuropathic ulcer.\n* atypical site of venous ulcer.\n* acute onset DVT.\n* age \\< 12 years.'}, 'identificationModule': {'nctId': 'NCT04834232', 'briefTitle': 'Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study Between Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration', 'orgStudyIdInfo': {'id': 'stenting & compression therapy'}}, 'armsInterventionsModule': {'interventions': [{'name': 'compression therapy', 'type': 'DEVICE', 'description': 'compression bandaging or graduated compression hosiery consists of applying a type of elastic device, mainly on the limbs, to exert a controlled pressure on the lower limbs. The controlled pressure exerted by medical compression stockings reduces the diameter of major veins, thereby increasing the velocity and volume of blood flow, along with conditions beneficial for the healing of chronic inflammatory disorders (e.g. cellulitis, erysipelas, venous leg ulcers, etc.), through reduced pro-inflammatory cytokine levels and higher levels of the anti-inflammatory cytokines.'}, {'name': 'iliac vein stenting', 'type': 'PROCEDURE', 'description': 'using x-ray guidance (fluoroscopy) to place a an expandable metal mesh tube against the vein walls, acting as a scaffold to keep the veins open and improve blood flow'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mohamed hesham abdelrahem husiein', 'investigatorAffiliation': 'Assiut University'}}}}