What side effects are associated with this type of intervention?

Sclerotherapy, which involves injecting a sclerosing agent to shrink blood vessels, can cause side effects such as pain at the injection site, swelling, bruising, and, in rare cases, blood clots or allergic reactions. Ablation, which destroys tissue using heat, cold, or chemicals, may lead to side effects including pain, swelling, bruising, skin burns, nerve damage, and, in some cases, infection. Both treatments are generally well-tolerated but carry risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Venous Reflux Disease, including sclerotherapy and various ablation techniques. Sclerotherapy involves the injection of a sclerosing agent, such as polidocanol or sodium tetradecyl sulfate, to shrink blood vessels. Ablation techniques, which include endovenous laser ablation (EVLA) and radiofrequency ablation (RFA), use heat to destroy the affected vein tissue. These treatments are designed to improve blood flow and reduce symptoms associated with venous reflux.

What other types of research exist?

Promising novel alternatives to sclerotherapy and ablation for venous reflux disease include endovenous laser therapy (EVLT), radiofrequency ablation (RFA), and mechanochemical ablation (MOCA). These minimally invasive techniques offer effective treatment with reduced recovery times and fewer complications compared to traditional methods.

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Sclerosing Agent

Sclerotherapy for Venous Ulcers

N/A

Waitlist Available

Led By Jihad Abbas, MD

Research Sponsored by ProMedica Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have saphenous vein reflux and a single venous ulcer of any size

Be older than 18 years old

Must not have

Patients with multiple venous ulcers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months following start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different treatment schedules for chronic venous ulcers. One group receives both treatments immediately, while the other group receives the second treatment later. Both groups also use a method to support vein healing. The goal is to see which approach heals the ulcers faster and improves patients' quality of life. One treatment involves injecting a solution into veins, while the other uses heat to close off veins.

Who is the study for?

This trial is for patients with a single venous ulcer of any size and saphenous vein reflux. It's not suitable for those who have multiple venous ulcers.

What is being tested?

The study aims to compare the effectiveness of sclerotherapy (injecting a solution into the affected veins) alone versus combining it with ablation (a procedure that closes off problematic veins).

What are the potential side effects?

Sclerotherapy may cause side effects like bruising, redness, pain at injection site, or allergic reactions to Polidocanol. Ablation might lead to skin burns, nerve damage, or blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have vein issues in my leg and one leg ulcer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have more than one leg ulcer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months following start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months following start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

3 Month Clinical Evaluation; Change Assessment

3 Month Ulcer Healing Rate Change

3 Month Ulcer Size (Depth)

+24 more

Secondary study objectives

Number of Days to Healed Status

Side effects data

From 2014 Phase 4 trial • 106 Patients • NCT02054325

51%

Hyperpigmentation

100%

80%

60%

40%

20%

Study treatment Arm

Polidocanol With Glucose

Glucose

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2: Sclerotherapy OnlyExperimental Treatment1 Intervention

Experimental Timeline: Arm 2 will be patients who receive sclerotherapy at the start of treatment along with compression therapy, and ablation 3 months later. All patients in arm 2 will receive ablation at their 3 month appointment. After ablation, the patients in arm 2 will not receive any further treatment for the remainder of the study.

Group II: Arm 1: Combination Sclerotherapy & AblationActive Control1 Intervention

Standard Practice: Arm 1 will be patients receiving sclerotherapy and ablation at the start of treatment along with compression therapy. The patients in arm 1 will not receive any further treatment during the duration of the study.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Venous Reflux Disease include sclerotherapy and ablation. Sclerotherapy involves injecting a sclerosing agent into the affected veins, causing them to shrink and be reabsorbed by the body, thereby reducing blood pooling and alleviating symptoms. Ablation uses heat, cold, or chemicals to destroy the problematic vein tissue, leading to vein closure and rerouting blood flow to healthier veins. These treatments improve blood circulation and reduce symptoms such as swelling, pain, and ulceration, significantly enhancing the quality of life for patients with Venous Reflux Disease.

Analysis of the vein wall destruction under endovenous laser ablation in an ex vivo model.