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AzTrials

TelangectasiaELF-HTRNCT07162844

Foam and Liquid Sclerotherapy With or Without Herbal Gel for Small Vein Treatment

A study testing Liquid sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure, Liquid sclerotherapy in telangectasia and reticular veins wit application of herbal gel post procedure and foam sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure in people with Telangectasia and Reticular Veins, run by Kafrelsheikh University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Telangiectasias (spider veins) and reticular veins represent early and common manifestations of chronic venous insufficiency . Telangiectasias are dilated intradermal venules or capillaries less than 1 mm in diameter and typically appear on the thighs, calves, or ankles in a red, pink, or purple hue. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Telangectasia, Reticular Veins
What is being tested?
Liquid sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure, Liquid sclerotherapy in telangectasia and reticular veins wit application of herbal gel post procedure and foam sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
508 participants
Where
1 siteEgypt
Study dates
5 Sep 2024to 1 Sep 2025
Phase
Interventional
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • telangiectasis on thigh or leg side
  • Competent saphenofemoral and saphenopoliteal junction
  • Patient post surgical stripping or post thermal ablation
  • clinical classification of chronic venous disease C1(mild venous disease), -
  • minimum age of 18 year-old and maximum age 65 year-old -

Who cannot join

  • varicose disease in any quantity or location with clinical classification of chronic venous
  • disease different of C1(mild venous disease)
  • arterial insufficiency
  • patient allergic to the sclerosant material or herbal gel
  • dermatitis on application site
  • patient with serious comorbidities like heart failure, respiratory failure, - uncontrolled hypertension with medication, and uncontrolled hypothyroidism - pregnancy - previous deep vein thrombosis (DVT) - family history of DVT - thrombophilia

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of medicine kfs university

    Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511

Other trials in Egypt

About this study

Official title: Effectiveness of Liquid Versus Foam Sclerotherapy With or Without Herbal Gel in Treating Telangiectasia and Reticular Veins: A Randomized Controlled Trial

Telangiectasias (spider veins) and reticular veins represent early and common manifestations of chronic venous insufficiency . Telangiectasias are dilated intradermal venules or capillaries less than 1 mm in diameter and typically appear on the thighs, calves, or ankles in a red, pink, or purple hue. Reticular veins, measuring 1-3 mm, are dilated subdermal veins located slightly deeper and often function as feeder veins to telangiectasias. They are commonly blue or green and may cause discomfort or cosmetic concerns.

According to the CEAP classification (Clinical-Etiology-Anatomy-Pathophysiology), telangiectasias and reticular veins fall under class C1. Chronic venous insufficiency of the lower extremities is increasingly prevalent, affecting nearly one-third of women and one-fifth of men, and can lead to symptoms such as leg fatigue, cramps, swelling, skin changes, or in advanced cases, deep vein thrombosis or pulmonary embolism. Telangiectasias are often the first visible signs of CVI and are frequently treated for cosmetic purposes.

Read more

Sclerotherapy is a well-established treatment for C1 venous disease. It involves the injection of a sclerosant agent into abnormal veins, causing endothelial damage, inflammation, and eventual fibrosis and closure of the vein. Among the most commonly used sclerosants are detergent-type agents like sodium tetradecyl sulfate (STS) and polidocanol (POL), which have been used effectively in both liquid and foam forms.

Liquid sclerotherapy has been employed for over 160 years, offering a minimally invasive approach to treat superficial veins. Foam sclerotherapy, introduced by Orbach and further popularized in recent decades, involves mixing the sclerosant with air or gas to form a microbubble foam. This form has increased surface area contact with the endothelium, potentially enhancing efficacy, particularly in larger veins. However, debate remains regarding the relative safety and effectiveness of foam versus liquid sclerotherapy, especially for small vessels such as telangiectasias and reticular veins.

Several clinical studies, including those by Kaygin and Halici, have compared foam and liquid sclerotherapy in treating lower limb varicose veins. Both forms have demonstrated efficacy and acceptable safety profiles. Nonetheless, further research is needed to determine the optimal form of sclerotherapy, especially in relation to cosmetic outcomes, pain, patient satisfaction, and side effect profiles. This study aims to compare the effectiveness and safety of liquid versus foam sclerotherapy, with or without herbal application in the treatment of telangiectasias and reticular veins.

Read the detailed description

Telangiectasias, also known as spider veins, are dilated intradermal venules less than 1 mm in diameter. They often appear close to the surface of the skin in a tree-like pattern and may be red, blue, or purple. Spider veins are commonly located on the thighs, calves, or ankles and are primarily of cosmetic concern.

Reticular veins are slightly larger, measuring 1-3 mm in diameter, and are located just beneath the skin surface. They are bluish or greenish in color and often act as feeder veins to telangiectasias. Reticular veins are commonly found on the legs but can also appear on the face, breasts, or knees. While they do not typically protrude like varicose veins, they may cause discomfort or pain and contribute to an unattractive marbled skin appearance.

Both telangiectasias and reticular veins are classified as C1 disease within the CEAP (Clinical, Etiological, Anatomical, Pathophysiological) classification of chronic venous disorders. Chronic venous insufficiency is associated with dilatation of lower extremity veins, impaired venous return, and abnormal blood stasis. It is a common condition affecting a significant proportion of both men and women, and may be associated with symptoms such as swelling, fatigue, cramps, and restless legs. If left untreated, it can progress to more serious complications, including venous thrombosis.

Sclerotherapy is a well-established treatment for telangiectasias and reticular veins. It involves injection of a sclerosant solution into the affected veins, leading to endothelial damage, inflammation, and fibrosis. Historically, liquid sclerotherapy has been in use for over 160 years. More recently, foam sclerotherapy was developed to enhance the contact between sclerosant and the vein wall, potentially improving efficacy. Both liquid and foam sclerotherapy are considered safe and effective, though their comparative advantages remain under investigation.

Herbal gels with anti-inflammatory and venotonic properties have been explored as adjuvant therapies in the treatment of superficial venous disease. These may help reduce post-procedural symptoms, improve patient comfort, and enhance cosmetic results. However, clinical evidence regarding their effectiveness in combination with liquid or foam sclerotherapy is limited.

Rationale Telangiectasias and reticular veins represent a prevalent form of chronic venous disease with both cosmetic and symptomatic impact. While sclerotherapy is the primary treatment, the relative benefits of foam versus liquid sclerotherapy, as well as the potential added value of herbal gels, remain uncertain. A randomized controlled trial is therefore warranted to compare these approaches and evaluate their clinical outcomes.

Being tested
Liquid sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure, Liquid sclerotherapy in telangectasia and reticular veins wit application of herbal gel post procedure, foam sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure, foam sclerotherapy in telangectasia and reticular veins with application of herbal gel post procedure
Keywords
Telangectasia, Reticular veins, foam, Sclerotherapy, C1, liquid, varicose

What participants receive

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

  • Liquid sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedureProcedure or surgery

    Liquid sclerotherapy injection of polidocanol in telangectasia and reticular veins without application of herbal gel post procedure

  • Liquid sclerotherapy in telangectasia and reticular veins wit application of herbal gel post procedureProcedure or surgery

    Liquid sclerotherapy injection of polidocanol in telangectasia and reticular veins with application of herbal gel post procedure

  • foam sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedureProcedure or surgery

    foam sclerotherapy injection of polidocanol in telangectasia and reticular veins without application of herbal gel post procedure

  • foam sclerotherapy in telangectasia and reticular veins with application of herbal gel post procedureProcedure or surgery

    foam sclerotherapy injection of polidocanol in telangectasia and reticular veins with application of herbal gel post procedure

Study groups in NCT07162844
Study groupRoleWhat they receive
liquid sclerotherapy injection without application of herbal gel after procedureExperimentalParticipants in this group will receive liquid polidocanol injection sclerotherapy without herbal gel application
Receives: Procedure: Liquid sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure
liquid sclerotherapy injection with application of herbal gel after procedureExperimentalParticipants in this group will receive liquid polidocanol injection sclerotherapy, followed by the application of a herbal gel topically at the injection site. The gel is applied immediately post-procedure twice daily
Receives: Procedure: Liquid sclerotherapy in telangectasia and reticular veins wit application of herbal gel post procedure
foam sclerotherapy injection without application of herbal gel after procedureExperimentalParticipants in this group will receive foam polidocanol injection sclerotherapy without application of herbal gel
Receives: Procedure: foam sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure
foam sclerotherapy injection with application of herbal gel after procedureExperimentalParticipants in this group will receive foam polidocanol injection sclerotherapy, followed by the application of a herbal gel topically at the injection site. The gel is applied immediately post-procedure twice daily
Receives: Procedure: foam sclerotherapy in telangectasia and reticular veins with application of herbal gel post procedure

What is being measured

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

  1. Change in Appearance of Telangiectasia and Reticular Veins Assessed by the Physician and Patient Global Assessment Scale

    Improvement from baseline in appearance of telangiectasia and reticular veins, assessed using a 5-point Global Assessment Scale (0 = no improvement, 4 = complete resolution). Both physician and patient will provide independent scores.

    Measured: 4 weeks

Secondary outcomes (1)
  1. Number of Participants with Treatment-Related Adverse Events

    Incidence of adverse events including hyperpigmentation, bruising, allergic reaction, and anaphylaxis, assessed through clinical examination and patient report.

    Measured: 4 weeks after treatment

Timeline

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

  1. First posted9 Sep 2025
  2. Study start5 Sep 2024
  3. Primary completion5 Aug 2025
  4. Study completion1 Sep 2025 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, controlled, parallel-group clinical trial with four intervention arms. Eligible participants will be randomly assigned to receive one of the following treatments: foam polidocanol alone, liquid polidocanol alone, foam polidocanol combined with herbal gel, or liquid polidocanol combined with herbal gel. Each participant will receive only the assigned intervention throughout the study. The parallel assignment model allows for independent comparison of treatment efficacy and safety between the four groups.
Masking
None (open label)
Enrolment
508 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07162844
Sponsor's protocol ID
KFSIRB200-348
Other IDs
KFSIRB200-348
Acronym
ELF-HTR
Status last verified
Aug 2025
First submitted
25 Aug 2025
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Liquid sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure, Liquid sclerotherapy in telangectasia and reticular veins wit application of herbal gel post procedure and foam sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure in people with Telangectasia and Reticular Veins, run by Kafrelsheikh University at 1 site in Egypt.

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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Appearance of Telangiectasia and Reticular Veins Assessed by the Physician and Patient Global Assessment Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Sep 2025.

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