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Sclerosing Agent

Sclerotherapy for Venous Ulcers

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months following start of treatment

Awards & highlights

Study Summary

This trial tests if a combination of special treatments can help heal ulcers better than a single treatment alone.

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.Check my eligibility

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).See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

3 Month Clinical Evaluation; Change Assessment

3 Month Ulcer Healing Rate Change

3 Month Ulcer Size (Depth)

+24 more

Secondary outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jobst Vascular InstituteUNKNOWN

ProMedica Health SystemLead Sponsor

13 Previous Clinical Trials

730 Total Patients Enrolled

Jihad Abbas, MDPrincipal InvestigatorProMedica Health System

Media Library

Polidocanol (Sclerosing Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05633277 — N/A

Venous Reflux Disease Research Study Groups: Arm 1: Combination Sclerotherapy & Ablation, Arm 2: Sclerotherapy Only

Venous Reflux Disease Clinical Trial 2023: Polidocanol Highlights & Side Effects. Trial Name: NCT05633277 — N/A

Polidocanol (Sclerosing Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633277 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has enrollment in this clinical experiment been successful?

"That is accurate. According to clinicaltrials.gov, this research project began recruiting participants on September 30th 2020 and is still open for applications. It seeks to enroll a total of 30 individuals at 1 site."

Answered by AI

Is enrollment open for this medical trial at the moment?

"Affirmative. According to information on clinicaltrials.gov, this research is presently enrolling participants. This experiment was first published on September 30th 2020 and has been adjusted as recently as November 28th 2022. The study necessitates the recruitment of 30 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections

Jihad Abbas, MD 2020. "Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05633277.