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

NCT05633277 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-01

No results posted yet for this study

Summary

Randomized Controlled Trial to determine if the outcomes of sclerotherapy of the ulcer bed alone differ from a combination of ablation and sclerotherapy injections.

Conditions

  • Venous Reflux
  • Venous Insufficiency
  • Venous Ulcer
  • Venous Disease

Interventions

PROCEDURE

Polidocanol

Sclerotherapy of the ulcer bed (polidocanol, sodium tetradecyl, etc) either in conjunction with a greater saphenous vein ablation treatment (RFA, EVLT, Venaseal, Varithena) at the same time or 3 months later.

Sponsors & Collaborators

  • Jobst Vascular Institute

    collaborator UNKNOWN

  • ProMedica Health System

    lead OTHER

Principal Investigators

  • Fedor Lurie, PhD, MD · ProMedica Health System

  • Jihad Abbas, MD · ProMedica Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2023-09-30
Completion
2024-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05633277 on ClinicalTrials.gov