Recruiting

Sclerotherapy & Ablation

Sponsor:

ProMedica Health System

Code:

NCT05633277

Conditions

Venous Reflux

Venous Insufficiency

Venous Ulcer

Venous Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Polidocanol

Study Details

Brief 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

Study ID

NCT05633277

Start date

Sep 30, 2020

Status verified date

Nov, 2022

Completion date

Mar, 2024

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with multiple venous ulcers

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1: Combination Sclerotherapy & Ablation

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.

experimental: Arm 2: Sclerotherapy Only

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.

Interventions

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.

Primary outcome measure

  • Baseline Ulcer Healing Rate [ Time Frame: Start of Treatment (Baseline) ]
  • 3 Month Ulcer Healing Rate Change [ Time Frame: 3 months following start of treatment ]
  • 6 Month Ulcer Healing Rate Change [ Time Frame: 6 months following start of treatment ]
  • Baseline Ulcer Size (Length) [ Time Frame: Start of Treatment (Baseline) ]
  • Baseline Ulcer Size (Width) [ Time Frame: Start of Treatment (Baseline) ]
  • Baseline Ulcer Size (Surface Area) [ Time Frame: Start of Treatment (Baseline) ]
  • Baseline Ulcer Size (Depth) [ Time Frame: Start of Treatment (Baseline) ]
  • Baseline Ulcer Size (Volume) [ Time Frame: Start of Treatment (Baseline) ]
  • 3 Month Ulcer Size (Length) [ Time Frame: 3 months following start of treatment ]
  • 3 Month Ulcer Size (Width) [ Time Frame: 3 months following start of treatment ]
  • 3 Month Ulcer Size (Surface Area) [ Time Frame: 3 months following start of treatment ]
  • 3 Month Ulcer Size (Depth) [ Time Frame: 3 months following start of treatment ]
  • 3 Month Ulcer Size (Volume) [ Time Frame: 3 months following start of treatment ]
  • 6 Month Ulcer Size (Length) [ Time Frame: 6 months following start of treatment ]
  • 6 Month Ulcer Size (Width) [ Time Frame: 6 months following start of treatment ]
  • 6 Month Ulcer Size (Surface Area) [ Time Frame: 6 months following start of treatment ]
  • 6 Month Ulcer Size (Depth) [ Time Frame: 6 months following start of treatment ]
  • 6 Month Ulcer Size (Volume) [ Time Frame: 6 months following start of treatment ]
  • Baseline Clinical Evaluation [ Time Frame: Start of Treatment (Baseline) ]
  • 3 Month Clinical Evaluation; Change Assessment [ Time Frame: 3 months following start of treatment ]
  • 6 Month Clinical Evaluation; Change Assessment [ Time Frame: 6 months following start of treatment ]
  • Baseline_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym) [ Time Frame: Start of Treatment (Baseline) ]
  • 3 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment [ Time Frame: 3 months following start of treatment ]
  • 6 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment [ Time Frame: 6 months following start of treatment ]
  • Baseline_Venous Clinical Severity Score (VCSS) [ Time Frame: Start of Treatment (Baseline) ]
  • 3 Month_Venous Clinical Severity Score (VCSS); Change Assessment) [ Time Frame: 3 months following start of treatment ]
  • 6 Month_Venous Clinical Severity Score (VCSS); Change Assessment [ Time Frame: 6 months following start of treatment ]

Central Contacts and Locations

Central contacts

Fedor Lurie, PhD, MD

419-291-5997fedor.lurie@promedica.org

Locations

Jobst Vascular Institute, ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Fedor Lurie, PhD, MD

419-291-5997fedor.lurie@promedica.org

Principal Investigator:

Jihad Abbas, MD

More Information

Sponsor

ProMedica Health System

Last update posted

Dec 1, 2022

Last verified

Nov, 2022

Keywords

  • Sclerotherapy
  • Venous Ablation
  • Reflux
  • Insufficiency
  • Ulcer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ProMedica Health System on 2022-12-01.