[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-venous-insufficiency-cvi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-venous-insufficiency-cvi":179},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,79,106,128,161],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100638166","phase-2-clinical-investigation-of-safety-and-effectiveness-for-the-envve-system-100638166",false,"NCT07609927","Clinical Investigation of Safety and Effectiveness for the enVVe® System","The TrAnscatheter Venous Valve Endoprosthesis Clinical Investigation of Safety and Effectiveness for the enVVe® System","TAVVE","Inclusion Criteria:\n\n1. Persistent symptoms with at least 3 months of routine care including compression therapy, pneumatic compression, and in C6 patients, wound care with FDA approved medications or dressing solutions\n2. Axial deep reflux \\>1 sec. in the femoral vein (above the P1 segment) and popliteal vein\n3. Primary or Secondary deep venous valvular incompetence\n4. CEAP score: C4b, C4c, C5, or C6\n5. Age ≥18 years\n6. Ability to stand for duplex ultrasound\n7. Ability to ambulate without assistance with appropriate heel to toe ambulation\n8. Able to attend scheduled post-treatment follow-up visits\n9. Absence of superficial reflux of the truncal vessels\n10. BMI \\\u003C40\n11. Female patients of childbearing potential must:\n\n    * have a negative pregnancy test at the screening visit or within 7 days of the index procedure, whichever is later,\n    * not be breastfeeding or plan to breastfeed through completion of the study,\n    * agree to use a medically acceptable method of preventing conception from the screening visit through completion of the study.\n\n    Pre-implant Venography and Imaging Inclusion Criteria\n12. Diameter of the Target Vein Zone of 7.5 mm - 11.5 mm (the diameter is the largest of proximal, mid, and distal sections of the Target Vein Zone measured with venography required prior to or during the procedure and IVUS performed during the procedure), as well as with Duplex Ultrasound imaging per Imaging Manual\n13. Diameter of the popliteal vein must be ≥4.7 mm to accommodate a 14 Fr Introducer sheath\n14. Planned placement of the enVVe Valve will not cover collateral veins\n\nExclusion Criteria:\n\n1. Known hypercoagulable condition including Factor V Leiden deficiency (homozygote), Prothrombin gene Mutation (homozygote), Antithrombin 3 deficiency, Protein C deficiency, Protein S deficiency and Antiphospholipid antibody\n2. Any active cancer or cancer within 6 months of remission (excluding non-melanoma skin cancer)\n3. Previous surgical procedure or endovascular procedure in the Target Vein Zone in the target extremity (ipsilateral leg)\n4. Acute Deep Venous Thrombosis (DVT) or pulmonary embolism (PE) within 30 days of the procedure\n5. Arterial insufficiency demonstrated by an ABI \\\u003C0.71 within 6 months\n6. Patients with primary Lymphedema Praecox or Tarda\n7. Superficial ablation ≤ 3 months of the procedure\n8. Unable to lie prone on the table\n9. Major surgery or prolonged hospitalization within 8 weeks of the procedure\n10. Patients with recurrent congestive heart failure (NYHA stage III)\n11. Patients with chronic narcotic or other drug use for chronic pain other than treatment for their CVI, or a history of substance (e.g. drug, alcohol) abuse\n12. Uncontrolled diabetes mellitus; A1C levels \\>13, toxic thyroidism, Tuberculosis (TB), neoplasm, sepsis, blood dyscrasias or acute respiratory or skin disease\n13. Immobilization or inability to ambulate or with muscle wasting of the target extremity (ipsilateral leg). Unable to perform a heal\u002Ftoe movement when walking\n14. Contraindication for anticoagulation or unwillingness to comply with long-term anticoagulation regimen (Heparin, low molecular weight (LMW) heparin by injection twice a day for 30 days, direct oral anticoagulation (DOAC) such as Xarelto or Eliquis for 5 years, Clopidogrel daily for at least 6 months)\n15. Contraindication for contrast injection procedures (contrast allergy that cannot be medically managed, renal insufficiency\u002Fchronic kidney disease with potentially worsening renal function) and when CO2 imaging is not an option or unavailable\n16. Known nitinol sensitivity\u002F nickel sensitivity\u002F porcine tissue sensitivity or polyethylene terephthalate (PET) sensitivity\n17. Active superficial thrombophlebitis\n18. Thrombocytosis \u002F platelets \\> 1 million\n19. Patients that will not allow needed blood and\u002For blood products (e.g., transfusion)\n20. Patients that have placement of stents within the ipsilateral femoral or popliteal veins\n21. Patients who have had balloon angioplasty of the ipsilateral femoral or popliteal veins within the past 6 months or are clinically determined to require such a procedure imminently. (waiting period of 6 months following balloon angioplasty is required)\n22. Adults who lack the capacity to provide informed consent\n23. Patients with life expectancy \\\u003C5 year due to illness\u002Fcancer\n24. Patients on renal dialysis\n25. Patients with previously implanted VenoValve in the ipsilateral or contralateral extremity\n26. Venous outflow obstruction of the iliac vein of \\> 60% (waiting period of 3 months following iliac vein stenting)\n27. Extensive infrainguinal obstruction of the deep venous system or Common Femoral Vein (CFV)\n28. Tortuous anatomy that precludes use of the enVVe System\n29. Non dominant femoral vein with significant competing flow in the collaterals\n30. Large competitive flow through the profunda vein near the confluence of the popliteal vein\n31. Any organ transplant, excluding ophthalmic related transplants\n32. Patients who are currently using any non-FDA-approved medication for the treatment of venous disease (e.g., venoactive drugs, compounds or supplements such as purified flavonoid fractions like diosmin and hesperidin)\n33. rVCSS scores of ≤ 7 at baseline","ALL","18 Years",{"count":20,"type":21},220,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","A staged prospective, randomized, non-blinded, multicenter study.",[28],"Chronic Venous Insufficiency, CVI","NOT_YET_RECRUITING","2026-05-20",{"date":32,"type":33},"2026-05-27","ACTUAL",{"date":35,"type":21},"2026-07-01",{"date":37,"type":21},"2033-07-01",{"name":39,"class":40},"Hancock Jaffe Laboratiores, Inc","NETWORK",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":61,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100633674","the-recana-for-lower-extremity-venous-obstructions-and-in-stent-restenosis-registry-100633674","NCT07529756","The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry","The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry (\"The CALIBER Registry\")","CALIBER","INCLUSION CRITERA:\n\nA. Native Vessel:\n\n1. INC-1: Subject is 18 years or older\n2. INC-2: Proximal lower extremity obstruction\u002Focclusion involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination that in the opinion of the investigator, treatment with the Recana would benefit the patient\n3. INC-3: Recana Thrombectomy Catheter System must enter vasculature\n4. INC-4: Willing and able to provide written informed consent\n\nB. In-Stent Restenosis:\n\n1. INC-1: Subject is 18 years or older\n2. INC-2: Subjects with stents implanted greater than 6 weeks prior to index procedure\n3. INC-3: Location of thrombosed stents in proximal lower extremity deep vein segments including common femoral, external iliac, common iliac vein, or inferior vena cava alone or in combination that in the opinion of the investigator treatment with the Recana would benefit the patient\n4. INC-4: Recana Thrombectomy Catheter System must enter vasculature\n5. INC-5: Willing and able to provide written informed consent\n\nEXCLUSION CRITERA\n\nA. Native Vessel:\n\n1. EXC-1: IVC aplasia\u002Fhypoplasia or other congenital anatomic anomalies of the IVC or iliac veins\n2. EXC-2: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure\n3. EXC-3: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana\n4. EXC-4: Heparin allergy or hypersensitivity that cannot be adequately managed with alternate anticoagulant during or after the procedure, or prior diagnosis of HIT (Heparin-Induced Thrombocytopenia)\n5. EXC-5: Severe, life-threatening allergy to iodine or contrast dye\n6. EXC-6: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period\n7. EXC-7: Life expectancy less than 1 year\n8. EXC-8: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status\n9. EXC-9: Known hypercoagulable states that, in the opinion of the investigator, cannot be medically managed throughout the study period\n10. EXC-10: Inability to secure venous access and cross lesion\n11. EXC-11: Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject\n12. EXC-12: Current active participation in another investigational drug or device study in which the primary endpoint has not been analyzed\n\nB. In-Stent Restenosis:\n\n1. EXC-1: Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel\n2. EXC-2: Stent failure caused by undersizing or malapposition of the stent(s) \\[For example, the segment of a stent in the iliac vein that is not wall apposed or cannot be apposed to the wall after balloon dilation is excluded. The segment of a stent that extends into the IVC that is not wall apposed would not be excluded.\\]\n3. EXC-3: Stents compressed to \\\u003C6mm that remain \\\u003C6mm after balloon dilation\n4. EXC-4: IVC filter in place at the time of index procedure that, in the judgment of the investigator, may interfere with the procedure\n5. EXC-5: Congenital anatomic anomalies of the iliac veins that in the opinion of the investigator would preclude treatment with the Recana\n6. EXC-6: Heparin allergy or hypersensitivity that cannot be adequately managed with alternate anticoagulant during or after the procedure, or prior diagnosis of HIT (Heparin-Induced Thrombocytopenia)\n7. EXC-7: Severe, life-threatening allergy to iodine or contrast dye\n8. EXC-8: Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period\n9. EXC-9: Life expectancy less than 1 year\n10. EXC-10: Chronic non-ambulatory status such as long-term wheelchair requirement or bedridden status\n11. EXC-11: Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period\n12. EXC-12: Inability to secure venous access and cross lesion\n13. EXC-13: Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject\n14. EXC-14: Current active participation in another investigational drug or device study in which the primary endpoint has not been analyzed",{"count":50,"type":21},87,"1 Year","OBSERVATIONAL","The goal of this observational study is to gather additional safety and performance (effectiveness) data on the device for the treatment of symptomatic lower extremity venous obstructions and occlusions. The main questions the study aims to answer are:\n\n* What is the observed rate of safety events through the 30-day follow-up?\n* What is the rate of technical success (acute procedural success) achieved at the index procedure?\n\nParticipants already undergoing treatment with the Recana as part of their regular medical care will be followed for 1 year.",[55,28,56,57,58,59,60],"Chronic Venous Disease","Venous Thrombosis","Thrombosis (Stent Thrombosis)","Thrombosis, Venous","Embolism and Thrombosis","Thrombectomy",[62,63,64,65,66,67,68],"in-stent restenosis","venous obstruction or occlusion","thrombus","emboli","CALIBER Registry","recanalization","debulking","2026-05-07",{"date":71,"type":33},"2026-05-12",{"date":73,"type":21},"2026-06",{"date":75,"type":21},"2029-03",{"name":77,"class":78},"Intervene, Inc.","INDUSTRY",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":89,"studyType":52,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100611338","efficacy-and-safety-of-endovenous-ablation-for-relief-of-knee-pain-in-elderly-patients-with-lower-extremity-varicose-veins-a-prospective-observational-study-100611338","NCT07239284","Efficacy and Safety of Endovenous Ablation for Relief of Knee Pain in Elderly Patients With Lower Extremity Varicose Veins: A Prospective Observational Study","EVA-Knee-Elder","Inclusion Criteria:\n\nAdults aged ≥80 years. Clinical diagnosis of lower limb varicose veins with documented venous reflux on duplex ultrasound (CEAP C2-C4).\n\nPresence of knee pain lasting ≥4 weeks prior to enrollment, confirmed by patient-reported VAS\u002FNRS ≥3 at baseline.\n\nPlanned to undergo standard endovenous treatment (radiofrequency ablation, endovenous laser ablation, or equivalent).\n\nAbility to provide informed consent and complete study questionnaires.\n\nExclusion Criteria:\n\nPrior surgery or endovenous ablation for varicose veins in the same limb. History of inflammatory arthritis (e.g., rheumatoid arthritis, gout) or other systemic rheumatologic disease.\n\nRecent acute knee injury (ligament, meniscus, fracture) within 6 months. Prior knee replacement or major knee surgery. Recent intra-articular injection or arthroscopy (\\\u003C3 months). Known deep vein thrombosis or history of pulmonary embolism within the past 6 months.\n\nSevere peripheral arterial disease (ABI \\\u003C0.8). Pregnancy or breastfeeding. Inability to comply with follow-up schedule or complete questionnaires.","80 Years",{"count":88,"type":21},50,"6 Months","Lower extremity varicose veins (LEVV) are common among elderly patients and can cause leg heaviness, pain, and swelling. In some older adults, venous congestion may contribute to knee or peri-knee pain, which is often misattributed to degenerative joint disease alone. Evidence on whether varicose vein treatment can relieve knee pain in very elderly patients (aged 80 years or older) is limited.\n\nThis prospective cohort study aims to evaluate the effectiveness and safety of endovenous ablation (EVA) for improving knee pain in elderly patients with symptomatic varicose veins. The study will include participants aged 80 years or older who present with both lower extremity varicose veins and knee joint pain. Eligible patients will undergo endovenous thermal ablation (radiofrequency or endovenous laser ablation) as the primary intervention.\n\nParticipants will be assessed at baseline, 1 month, 3 months, 6 months, and 12 months after treatment. The primary outcome is the change in knee pain intensity measured by the Visual Analog Scale (VAS) from baseline to 6 months. Secondary outcomes include changes in knee joint function (assessed by the Western Ontario and McMaster Universities Osteoarthritis Index \\[WOMAC\\] or Knee Injury and Osteoarthritis Outcome Score \\[KOOS\\]), venous clinical severity score (VCSS), limb heaviness, quality of life (assessed by EQ-5D), and procedure-related complications.\n\nSafety will be evaluated by recording peri-procedural adverse events, including deep vein thrombosis, skin burns, nerve injury, and postoperative infection. The study will also analyze whether preexisting osteoarthritis, venous reflux severity, or body mass index (BMI) affect the magnitude of pain improvement.\n\nThe hypothesis is that endovenous ablation improves knee pain in elderly patients by reducing venous congestion around the knee and improving venous return. This study will help clarify whether treating varicose veins can provide additional benefits for knee pain and mobility in patients aged 80 years and older.",[92,28,93,94,95],"Varicose Veins of Lower Limb","Knee Pain","Knee Osteoarthritis","Elderly Patients","2025-11-16",{"date":98,"type":33},"2025-11-20",{"date":100,"type":21},"2025-12-10",{"date":102,"type":21},"2027-07-10",{"name":104,"class":105},"Chengdu University of Traditional Chinese Medicine","OTHER",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":113,"targetDuration":89,"studyType":52,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100610902","risks-and-benefits-of-radiofrequency-ablation-for-chronic-venous-insufficiency-ceap-c3-c6-in-patients-aged-80-and-over-100610902","NCT07233616","Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over","Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over: A Prospective Single-Arm Cohort Study","Inclusion Criteria:\n\n1. Age: Aged 80 years or older.\n2. Clinical Diagnosis: Symptomatic chronic venous insufficiency of the lower extremity, with the highest clinical class (CEAP classification) being one of the following:\n\n   * C3: Venous edema\n   * C4a: Pigmentation or eczema\n   * C4b: Lipodermatosclerosis or atrophie blanche\n   * C5: Healed venous ulcer\n   * C6: Active venous ulcer\n3. Confirmed Reflux: Color duplex ultrasound examination confirming reflux (reflux time \\> 0.5 seconds) in the great saphenous vein (GSV) and\u002For small saphenous vein (SSV) of the target limb.\n4. Informed Consent: The patient or their legally authorized representative is able to understand and voluntarily provides written informed consent.\n\nExclusion Criteria:\n\n* Participants who meet any of the following criteria will be excluded from the study:\n\n  1. Mobility: Non-ambulatory or bedridden.\n  2. Thrombosis: Presence of acute superficial thrombophlebitis of the target vein, or deep vein thrombosis (DVT) in the target limb.\n  3. Arterial Disease: Significant peripheral arterial disease, defined as an ankle-brachial index (ABI) \\\u003C 0.8 in the target limb.\n  4. Coagulopathy: Uncorrectable coagulation disorder.\n  5. Allergy: Known severe allergy to local anesthetics (e.g., lidocaine) or relevant device materials.\n  6. Cognition \\& Compliance: Severe cognitive impairment or psychiatric illness that, in the investigator's judgment, precludes adequate understanding and cooperation for the study procedures and follow-up.\n  7. Life Expectancy: Life expectancy of less than 1 year due to other comorbid conditions (e.g., terminal malignancy).\n  8. General Unsuitability: Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.",{"count":88,"type":21},"The prevalence of severe chronic venous insufficiency (CVI) is significant in the growing octogenarian population. While radiofrequency ablation (RFA) is a standard minimally invasive treatment, robust data on its outcomes and safety profiles specifically in patients aged 80 years and older remain scarce. This study aims to evaluate the risks and benefits of RFA in this specific, high-risk demographic.This prospective, single-arm, single-center cohort study will enroll 50 patients (initial target sample size) aged ≥80 years with CVI classified as CEAP C3 to C6 and with confirmed great or small saphenous vein reflux. All participants will undergo endovenous RFA under tumescent local anesthesia. The primary outcomes are: 1) the great\u002Fsmall saphenous vein occlusion rate at 6 months, assessed by duplex ultrasonography, and 2) the change in disease-specific quality of life from baseline to 6 months, measured by the Aberdeen Varicose Vein Questionnaire (AVVQ). Secondary outcomes include occlusion rates at 1 and 3 months; complication rates (e.g., deep vein thrombosis, skin burns, paresthesia) within 30 days; and changes in the Venous Clinical Severity Score (VCSS) and the 12-Item Short Form Health Survey (SF-12) at predefined intervals over 6 months.This study is designed to demonstrate a high technical success rate (occlusion rate \\>95% at 6 months) and a statistically significant improvement in AVVQ and VCSS scores at 6 months post-procedure. The collected data will provide a detailed profile of complication rates, characterizing the safety of RFA in this very elderly cohort.This study will provide crucial, prospective evidence regarding the efficacy and safety of RFA for treating CVI in octogenarians. The findings are expected to guide clinical decision-making and inform treatment guidelines for this vulnerable and expanding patient population.",[28,116,117,118],"Radiofrequency Ablation","Octogenarians(Aged 80 and Over)","Cohort Study","RECRUITING",{"date":121,"type":33},"2025-11-18",{"date":123,"type":33},"2025-10-01",{"date":125,"type":21},"2026-09-01",{"name":104,"class":105},1,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100577474","reducing-skin-tone-inequities-in-chronic-venous-insufficiency-100577474","NCT06798766","Reducing Skin Tone Inequities in Chronic Venous Insufficiency","Reducing Health Inequities Through Improved Guidance and Assessment on the Early Identification of Skin Changes Associated With Chronic Venous Insufficiency (CVI) in People With Dark Skin Tones","Work-package 1 - Mapping patient journeys and patient experiences Participant inclusion criteria\n\n* people with chronic venous insufficiency, or their close family member\n* the person with chronic venous insufficiency has a dark skin tone (from Ho and Robinson skin tone range 2b-6b, table 1).\n* ability to give informed consent Participant exclusion criteria\n* person with chronic venous insufficiency has a light skin tone (from Ho and Robinson skin tone range 1a-2a, table 1).\n* people unable to speak and understand English\n* people unable to give informed consent.\n\nWork package 2 - Informing skin assessment technique and medical photography Participant inclusion criteria\n\n* people diagnosed with chronic venous insufficiency at NHS trust\n* people with a dark skin tones (from Ho and Robinson skin tone range 2b-6b, table 1).\n* ability to give informed consent\n* either coming back to the hospital for surgery or being able to travel back to the hospital to undergo physical assessment and skin photography prior to any intervention.\n* have duplex ultra-sound scan informing clinical diagnosis of venous disease. Participant exclusion criteria\n* person with chronic venous insufficiency has a light skin tones (from Ho and Robinson skin tone range 1a-2a, table 1).\n* people unable to speak and understand English\n* people unable to give informed consent.",{"count":136,"type":21},51,"The aim of this project is to define assessment criteria for chronic venous insufficiency (CVI) in people with dark skin tones. It will inform future interventions and modifications to practice for the assessment of CVI in people with dark skin tones in a nurse led intervention to improve patient assessment.\n\nTo achieve this there will be two parts to this study.\n\n1. We will explore patient journeys and patient experiences of people with dark skin tones diagnosed with chronic venous insufficiency. From this we will learn from people with dark skin tones about how they recognised skin changes in their lower legs to further inform clinical assessment guidance and techniques. We will also listen to their patient journey to identify what areas worked well and what could be developed. This will help us plan how care could be improved for similar people.\n2. We will record how skin changes look and feel in people with dark skin tones and known venous disease, and photograph this. We will consider whether some additional techniques used in practice to look and feel the skin is useful and whether changing the colour balance and manipulating the photographs is useful to see these skin changes.",[28,139,140,141],"Chronic Venous Insufficiency C2 or Higher","Chronic Venous Disease of Lower Limbs","Venous Leg Ulcer (VLU)",[143,144,145,146,147,148,149,150],"health inequities","skin tone inequities","health equality","skin tone equality","skin assessment","physical examination","patient journey","patient experience","2025-09-09",{"date":153,"type":33},"2025-09-16",{"date":155,"type":33},"2025-06-01",{"date":157,"type":21},"2026-04-30",{"name":159,"class":105},"King's College London",2,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":169,"targetDuration":89,"studyType":52,"phases":4,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100605499","knee-pain-relief-after-endovenous-treatment-for-lower-limb-varicose-veins-a-prospective-observational-study-100605499","NCT07163312","Knee Pain Relief After Endovenous Treatment for Lower Limb Varicose Veins: A Prospective Observational Study","Prospective Observational Cohort Study of Knee Pain and Function After Endovenous Treatment for Lower Limb Varicose Veins","VV-KNEE","Inclusion Criteria:\n\nAdults aged ≥18 years. Clinical diagnosis of lower limb varicose veins with documented venous reflux on duplex ultrasound (CEAP C2-C4).\n\nPresence of knee pain lasting ≥4 weeks prior to enrollment, confirmed by patient-reported VAS\u002FNRS ≥3 at baseline.\n\nPlanned to undergo standard endovenous treatment (radiofrequency ablation, endovenous laser ablation, or equivalent).\n\nAbility to provide informed consent and complete study questionnaires.\n\nExclusion Criteria:\n\nPrior surgery or endovenous ablation for varicose veins in the same limb. History of inflammatory arthritis (e.g., rheumatoid arthritis, gout) or other systemic rheumatologic disease.\n\nRecent acute knee injury (ligament, meniscus, fracture) within 6 months. Prior knee replacement or major knee surgery. Recent intra-articular injection or arthroscopy (\\\u003C3 months). Known deep vein thrombosis or history of pulmonary embolism within the past 6 months.\n\nSevere peripheral arterial disease (ABI \\\u003C0.8). Pregnancy or breastfeeding. Inability to comply with follow-up schedule or complete questionnaires.",{"count":88,"type":21},"This study will observe patients with lower limb varicose veins who also have knee pain. Many patients with varicose veins experience swelling, heaviness, or aching in the legs, and some also report pain in or around the knee. Previous studies suggest that venous reflux and poor circulation may increase discomfort in the knee, especially when knee osteoarthritis is present.\n\nThe purpose of this study is to evaluate whether treatment of varicose veins with standard endovenous procedures can improve knee pain and function. Participants will undergo standard vein treatment as part of their clinical care. We will follow them for changes in knee pain, quality of life, and leg symptoms over time.\n\nThis study does not assign patients to experimental interventions. Instead, it collects information before and after treatment to better understand the relationship between varicose veins and knee pain relief. Findings from this study may help doctors identify which patients are most likely to benefit from venous treatment in terms of both leg and knee symptoms.",[92,28,172,94],"Knee Pain Chronic","2025-09-01",{"date":151,"type":33},{"date":123,"type":21},{"date":177,"type":21},"2026-11-01",{"name":104,"class":105},"Chronic Venous Insufficiency (CVI)"]