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AzTrials

Varicose Veins of Lower LimbEVA-Knee-ElderNCT07239284

Efficacy and Safety of Endovenous Ablation for Relief of Knee Pain in Elderly Patients With Lower Extremity Varicose Veins: A Prospective Observational Study

An observational study of Varicose Veins of Lower Limb and Chronic Venous Insufficiency, CVI, run by Chengdu University of Traditional Chinese Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 80 years and older
What is being tested?
Endovenous Ablation for Varicose Veins
Type of treatment
Surgery or procedure
How many people
50 participants
Where
No sites listed yet
Study dates
10 Dec 2025to 10 Jul 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: This study will enroll elderly patients aged 80 years or older who are diagnosed with primary lower extremity varicose veins and who also experience knee or peri-knee pain. Participants will be recruited from the outpatient vascular surgery clinics and inpatient wards of the participating hospital. All participants must be ambulatory and able to complete pain and function questionnaires. The study population represents older adults who are candidates for endovenous ablation under tumescent local anesthesia and who may benefit from venous reflux correction.

Who may be able to join

  • Adults aged ≥80 years. Clinical diagnosis of lower limb varicose veins with documented venous reflux on duplex ultrasound (CEAP C2-C4).
  • Presence of knee pain lasting ≥4 weeks prior to enrollment, confirmed by patient-reported VAS/NRS ≥3 at baseline.
  • Planned to undergo standard endovenous treatment (radiofrequency ablation, endovenous laser ablation, or equivalent).
  • Ability to provide informed consent and complete study questionnaires.

Who cannot join

  • Prior 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.
  • Recent acute knee injury (ligament, meniscus, fracture) within 6 months. Prior knee replacement or major knee surgery. Recent intra-articular injection or arthroscopy (<3 months). Known deep vein thrombosis or history of pulmonary embolism within the past 6 months.
  • Severe peripheral arterial disease (ABI <0.8). Pregnancy or breastfeeding. Inability to comply with follow-up schedule or complete questionnaires.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Chunshui He contact

18981885601

Chunshuihe@msn.com

About this study

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.

This 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.

Read more

Participants 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.

Safety 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.

The 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.

Being tested
Endovenous Ablation for Varicose Veins
Medical subject headings
Blindness, Cortical, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovenous Ablation for Varicose VeinsProcedure or surgery

    Also called Endovenous Thermal Ablation, Radiofrequency Ablation, Endovenous Laser Ablation

    Participants will receive standard endovenous treatment for lower limb varicose veins as part of their routine clinical care. The procedure may include radiofrequency ablation (RFA), endovenous laser ablation (EVLA), or other accepted thermal ablation techniques, with or without adjunctive phlebectomy or foam sclerotherapy if clinically indicated. The intervention is performed under tumescent local anesthesia by vascular surgeons according to established guidelines. No experimental techniques or investigational devices are used.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Knee Pain Score (VAS)

    Visual Analog Scale (VAS, 0-10 cm)

    Measured: Baseline, 1 month, 3 months, and 6 months

  2. Change in Knee Function and Symptoms

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) evaluates knee-related pain, stiffness, and functional limitations.Scoring Range: 0 to 96, with higher scores indicating worse symptoms and greater functional impairment.

    Measured: Baseline, 1 month, 3 months, and 6 months

Secondary outcomes (5)

  1. Change in Venous Clinical Severity Score (VCSS)

    The Venous Clinical Severity Score (VCSS) assesses the severity of chronic venous disease and varicose vein-related symptoms.Scoring Range: 0 to 30, with higher scores indicating more severe venous disease.

    Measured: Baseline, 1 month, 3 months, and 6 months.

  2. Change in Aberdeen Varicose Vein Questionnaire (AVVQ)

    The Aberdeen Varicose Vein Questionnaire (AVVQ) measures varicose vein-specific quality of life.Scoring Range: 0 to 100, with higher scores indicating worse quality of life.

    Measured: Baseline, 1 month, 3 months, and 6 months.

  3. Change in Health-Related Quality of Life

    The Chronic Venous Insufficiency Questionnaire (CIVIQ-14) is a 14-item disease-specific instrument used to assess quality of life in patients with chronic venous disease. It covers domains of pain, physical function, and psychological impact. Scoring Range: 0 to 100, with higher scores indicating worse quality of life.

    Measured: Baseline, 1 month, 3 months, and 6 months

  4. Use of Analgesic Medications

    Number of patients using NSAIDs or other pain medications for knee pain.

    Measured: 6 months.

  5. Adverse Events Related to Procedure

    Number and type of adverse events (nerve injury, phlebitis, DVT, infection).

    Measured: Within 6 months after procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start10 Dec 2025 (estimated)
  3. Primary completion10 Dec 2026 (estimated)
  4. Study completion10 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07239284
Sponsor's protocol ID
chengduUTCM knee-80
Acronym
EVA-Knee-Elder
Status last verified
Nov 2025
First submitted
16 Nov 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cao TN, Nguyen CT, Nguyen MD. The association between chronic venous disease and knee osteoarthritis. Eur Rev Med Pharmacol Sci. 2023 Apr;27(7):2899-2907. doi: 10.26355/eurrev_202304_31921.

    PubMed 37070890

  • Lesnyak OM, Zubareva EV, Goncharova MG, Maksimov DM. [Lower extremity venous diseases in primary knee osteoarthritis]. Ter Arkh. 2017;89(5):53-59. doi: 10.17116/terarkh201789553-59. Russian.

    PubMed 28631699

  • Oga Y, Sugiyama S, Matsubara S, Inaki Y, Matsunaga M, Shindo A. The Effectiveness of Endovenous Thermal Ablation for the Knee Symptoms of the Osteoarthritis with Varicose Veins. Ann Vasc Dis. 2021 Jun 25;14(2):108-111. doi: 10.3400/avd.oa.21-00016.

    PubMed 34239634

  • Gunes S, Sehim K, Cuneyt K, Gokmen D, Kucukdeveci AA. Is there a relationship between venous insufficiency and knee osteoarthritis? Turk J Phys Med Rehabil. 2020 Mar 3;66(1):40-46. doi: 10.5606/tftrd.2020.5110. eCollection 2020 Mar.

    PubMed 32318673

Questions about this trial

What is this clinical trial studying?

An observational study of Varicose Veins of Lower Limb and Chronic Venous Insufficiency, CVI, run by Chengdu University of Traditional Chinese Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chunshui He (18981885601, Chunshuihe@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Knee Pain Score (VAS) (time frame: Baseline, 1 month, 3 months, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07239284, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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