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

NCT07162844 | Active Not Recruiting DMC

• 1 other identifier: KFSIRB200-348
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Telangectasia; Reticular Veins

Keywords

Telangectasia; Reticular veins; foam; Sclerotherapy; C1; liquid; varicose

Outcome Measures

Primary Outcomes (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.

  4 weeks

Secondary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events

  4 weeks after treatment

Study Arms (4)

liquid sclerotherapy injection without application of herbal gel after procedure

EXPERIMENTAL

Participants in this group will receive liquid polidocanol injection sclerotherapy without herbal gel application

Procedure: Liquid sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure

liquid sclerotherapy injection with application of herbal gel after procedure

EXPERIMENTAL

Participants 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

Procedure: Liquid sclerotherapy in telangectasia and reticular veins wit application of herbal gel post procedure

foam sclerotherapy injection without application of herbal gel after procedure

EXPERIMENTAL

Participants in this group will receive foam polidocanol injection sclerotherapy without application of herbal gel

Procedure: foam sclerotherapy in telangectasia and reticular veins without application of herbal gel post procedure

foam sclerotherapy injection with application of herbal gel after procedure

EXPERIMENTAL

Participants 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

Procedure: foam sclerotherapy in telangectasia and reticular veins with application of herbal gel post procedure

Interventions

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

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

liquid sclerotherapy injection without application of herbal gel after procedure

Liquid sclerotherapy in telangectasia and reticular veins wit application of herbal gel post procedure PROCEDURE

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

liquid sclerotherapy injection with application of herbal gel after procedure

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

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

foam sclerotherapy injection without application of herbal gel after procedure

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

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

foam sclerotherapy injection with application of herbal gel after procedure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of medicine kfs university

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

Study Officials

• moustafa hassan mabrouk, lecturer

  faculty of medicine kfs university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the visible and physical differences between foam and liquid polidocanol, as well as the use of adjunctive herbal gel in some arms, masking of participants and investigators was not feasible. Therefore, the study is conducted as an open-label trial with no blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 9, 2025
• Study Start: September 5, 2024
• Primary Completion: August 5, 2025
• Study Completion: September 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)