Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-02 @ 2:49 AM
Study NCT ID:
NCT06209866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2024-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Glass Stage Compared to WIFI Stage in Predicting Limb Salvage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-20', 'studyFirstSubmitDate': '2024-01-06', 'studyFirstSubmitQcDate': '2024-01-16', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'Baseline', 'description': 'in - line arterial flow to the foot without any flow limiting dissection or residual stenosis \\> 30% on completion intraoperative arteriography'}, {'measure': 'Time to complete healing', 'timeFrame': 'Baseline', 'description': 'Time to complete healing of the wound after revascularization, Debridement or minor amputation'}, {'measure': 'Limb Salvage', 'timeFrame': 'Baseline', 'description': 'freedom from major amputation above the foot level'}, {'measure': 'Primary Patency', 'timeFrame': 'Baseline', 'description': 'uninterrupted vessel patency with no procedure performed on the treated limb.'}, {'measure': 'Assisted Primary Patency', 'timeFrame': 'Baseline', 'description': 'the percentage of failing but still patent vessel undergoing elective intervention, included patients required revision of the revascularization before vessel occlusion occurs as prophylactic interventions to maintain patency.'}, {'measure': 'Secondary Patency', 'timeFrame': 'Baseline', 'description': 'an occluded artery that required intervention to restore patency.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Limb-Threatening Ischemia']}, 'referencesModule': {'references': [{'pmid': '24820900', 'type': 'BACKGROUND', 'citation': 'Nehler MR, Duval S, Diao L, Annex BH, Hiatt WR, Rogers K, Zakharyan A, Hirsch AT. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. J Vasc Surg. 2014 Sep;60(3):686-95.e2. doi: 10.1016/j.jvs.2014.03.290. Epub 2014 May 10.'}, {'type': 'BACKGROUND', 'citation': 'Ananthakumar Murugavel, Ajay Savlania, Arunanshu Behera,Mandeep Kang, Comparison of GLASS Stage with WIfI Clinical Staging for Predicting Limb Salvage in Peripheral Arterial Disease.j.jvs.2023.01.104'}, {'pmid': '31182334', 'type': 'BACKGROUND', 'citation': 'Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8.'}, {'pmid': '24126108', 'type': 'BACKGROUND', 'citation': 'Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'compare between GLASS and WIFI Staging in predicting limb salvage in patients with chronic limb threatening ischemia ( CLTI) undergoing endovascular revascularization.', 'detailedDescription': 'Peripheral arterial disease (PAD) is estimated to affect over 200 million people worldwide. These rates are expected to rise as increasing life expectancies continue to shift the population toward older age. At the most severe end of the disease spectrum, chronic limb-threatening ischemia (CLTI) affects 11% of patients with PAD and is associated with high rates of limb loss and mortality as well as high costs of care.(1) The Society for Vascular Surgery\'s WIfI (Wound, Ischemia, foot Infection) staging system was developed to classify threatened limbs using factors that affect amputation risk and clinical management in patients with chronic limb threatening ischemia . These include the extent of the wound, degree of ischemia, and severity of any foot infection. It has been validated as a predictor of limb salvage in peripheral artery disease.(2,3)\n\nThe Global Vascular guidelines \'GVG "proposes a new Global Anatomic Staging System (GLASS), which is a new method of quantifying the anatomic severity of infrainguinal disease in patients with chronic limb-threatening ischemia. But it has not been used for predicting limb salvage apart from use as a tool in deciding the mode of intervention for patients with chronic limb-threatening ischemia (CLTI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at vascular surgery department of Assiut university', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nPatients with CLTI who will undergo endovascular revascularization at our department:\n\n• Rutherford stage 4 ( rest pain) ,stage 5 (ischemic ulceration not exceeding ulcer of the digits of the foot) , stage 6 ( severe ischemic ulcers or frank gangrene)\n\nExclusion Criteria:\n\n* Rutherford stage 1,2,3 Aortoiliac level of occlusion Unsalvageable limb Patients with contraindications to contrast media Non Atherosclerotic lschemia as • Acute ischemia\n\n * Post Traumatic Ischemia\n * Chronic ischemia caused by connective tissue diseases or vasculitis'}, 'identificationModule': {'nctId': 'NCT06209866', 'briefTitle': 'The Role of Glass Stage Compared to WIFI Stage in Predicting Limb Salvage', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Role Of Global Limb Anatomic Staging System ( GLASS) Compared to Wound, Ischemia, Foot Infection Stage ( WIFI) in Predicting Limb Salvage After Endovascular Revascularization Procedures in Chronic Limb Threatening Ischemia Patients', 'orgStudyIdInfo': {'id': 'Glass Stage and WIFI Stage'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PTA', 'type': 'DEVICE', 'description': 'Percutaneous Trans lumenal Angioplasty'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Ahmed Mohamed, Resident', 'role': 'CONTACT', 'email': 'mohamedbashandy20@gmail.com', 'phone': '01028524010'}, {'name': 'Mohamed Salah Abdelkareem, Lecturer', 'role': 'CONTACT', 'email': 'dms@aun.edu.eg', 'phone': '01067568289'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mohamed.15235432@med.aun.edu.eg', 'investigatorFullName': 'Mohamed Ahmed Mohamed Bashandi', 'investigatorAffiliation': 'Assiut University'}}}}