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

NCT05633277 | Unknown DMC

• 1 other identifier: 20-117
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Sclerotherapy; Venous Ablation; Reflux; Insufficiency; Ulcer

Outcome Measures

Primary Outcomes (27)

• Baseline Ulcer Healing Rate

  A measure of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)

  Start of Treatment (Baseline)

• 3 Month Ulcer Healing Rate Change

  A measure in the change of the percentage of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)

  3 months following start of treatment

• 6 Month Ulcer Healing Rate Change

  A measure in the change of the percentage of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)

  6 months following start of treatment

• Baseline Ulcer Size (Length)

  Measurement of the ulcer; Recorded in centimeters (cm)

  Start of Treatment (Baseline)

• Baseline Ulcer Size (Width)

  Measurement of the ulcer; Recorded in centimeters (cm)

  Start of Treatment (Baseline)

• Baseline Ulcer Size (Surface Area)

  Measurement of the ulcer; Recorded in centimeters squared (cm\^2)

  Start of Treatment (Baseline)

• Baseline Ulcer Size (Depth)

  Measurement of the ulcer; Recorded in centimeters (cm)

  Start of Treatment (Baseline)

• Baseline Ulcer Size (Volume)

  Measurement of the ulcer; Recorded in centimeters cubed (cm\^3)

  Start of Treatment (Baseline)

• 3 Month Ulcer Size (Length)

  Measurement of the ulcer; Recorded in centimeters (cm)

  3 months following start of treatment

• 3 Month Ulcer Size (Width)

  Measurement of the ulcer; Recorded in centimeters (cm)

  3 months following start of treatment

• 3 Month Ulcer Size (Surface Area)

  Measurement of the ulcer; Recorded in centimeters squared (cm\^2)

  3 months following start of treatment

• 3 Month Ulcer Size (Depth)

  Measurement of the ulcer; Recorded in centimeters (cm)

  3 months following start of treatment

• 3 Month Ulcer Size (Volume)

  Measurement of the ulcer; Recorded in centimeters cubed (cm\^3)

  3 months following start of treatment

• 6 Month Ulcer Size (Length)

  Measurement of the ulcer; Recorded in centimeters (cm)

  6 months following start of treatment

• 6 Month Ulcer Size (Width)

  Measurement of the ulcer; Recorded in centimeters (cm)

  6 months following start of treatment

• 6 Month Ulcer Size (Surface Area)

  Measurement of the ulcer; Recorded in centimeters squared (cm\^2)

  6 months following start of treatment

• 6 Month Ulcer Size (Depth)

  Measurement of the ulcer; Recorded in centimeters (cm)

  6 months following start of treatment

• 6 Month Ulcer Size (Volume)

  Measurement of the ulcer; Recorded in centimeters cubed (cm\^3)

  6 months following start of treatment

• Baseline Clinical Evaluation

  Clinical evaluation by the physician and assessment of the subject's symptoms

  Start of Treatment (Baseline)

• 3 Month Clinical Evaluation; Change Assessment

  Clinical evaluation by the physician and assessment of the subject's symptoms; later assessed for change from the previous visit.

  3 months following start of treatment

• 6 Month Clinical Evaluation; Change Assessment

  Clinical evaluation by the physician and assessment of the subject's symptoms; later assessed for change from the previous 2 visits.

  6 months following start of treatment

• Baseline_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym)

  The Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINS-QOL/Sym) Questionnaire measures the impact of CVI on symptoms and quality of life from the patient's perspective. It is an instrument with 26 items divided across eight questions. Question scales range from 0 (minimum) to 6 (maximum) although values may vary based on the question. The total score for the VEINES-QOL/Sym questionnaire is based on a standardized score (T score). Lower scores are associated with more severe symptoms.

  Start of Treatment (Baseline)

• 3 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment

  The Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINS-QOL/Sym) Questionnaire measures the impact of CVI on symptoms and quality of life from the patient's perspective. It is an instrument with 26 items divided across eight questions. VEINES-QOL/Sym mean score distribution for each category (varying range, 0-6). VEINES-QOL/Sym total standardized score (Mean T-score) =50. Lower scores are associated with more severe symptoms. Scores compared to the previous visit.

  3 months following start of treatment

• 6 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment

  The Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINS-QOL/Sym) Questionnaire measures the impact of CVI on symptoms and quality of life from the patient's perspective. It is an instrument with 26 items divided across eight questions. VEINES-QOL/Sym mean score distribution for each category (varying range, 0-6). VEINES-QOL/Sym total standardized score (Mean T-score) =50. Lower scores are associated with more severe symptoms. Scores compared to the previous 2 visits.

  6 months following start of treatment

• Baseline_Venous Clinical Severity Score (VCSS)

  Venous Clinical Severity Score (VCSS) are scored individually. VCSS mean score distribution for each category (range, 0-3). Higher scores are associated with more severe symptoms and disease.

  Start of Treatment (Baseline)

• 3 Month_Venous Clinical Severity Score (VCSS); Change Assessment)

  Venous Clinical Severity Score (VCSS) are scored individually. VCSS mean score distribution for each category (range, 0-3). Higher scores are associated with more severe symptoms and disease. Change from Baseline scores compared at 3 months.

  3 months following start of treatment

• 6 Month_Venous Clinical Severity Score (VCSS); Change Assessment

  Venous Clinical Severity Score (VCSS) are scored individually. VCSS mean score distribution for each category (range, 0-3). Higher scores are associated with more severe symptoms and disease. Change from Baseline and 3 month scores compared at 6 months.

  6 months following start of treatment

Secondary Outcomes (1)

• Number of Days to Healed Status

  From Date of Randomization until the date of documented healed status, assessed up to 365 days

Study Arms (2)

Arm 1: Combination Sclerotherapy & Ablation

ACTIVE COMPARATOR

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.

Procedure: Polidocanol

Arm 2: Sclerotherapy Only

EXPERIMENTAL

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.

Procedure: Polidocanol

Interventions

Polidocanol PROCEDURE

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.

Also known as: Radio Frequency Ablation, Endovenous Laser Ablation Therapy, Varithena, Venaseal, Sotradecol

Arm 1: Combination Sclerotherapy & Ablation; Arm 2: Sclerotherapy Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with multiple venous ulcers

Sponsors & Collaborators

• ProMedica Health System: lead
• Jobst Vascular Institute: collaborator

Study Sites (1)

Jobst Vascular Institute, ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

RECRUITING

Related Publications (5)

• de Araujo T, Valencia I, Federman DG, Kirsner RS. Managing the patient with venous ulcers. Ann Intern Med. 2003 Feb 18;138(4):326-34. doi: 10.7326/0003-4819-138-4-200302180-00012.

  PMID: 12585831 BACKGROUND

• O'Meara S, Al-Kurdi D, Ovington LG. Antibiotics and antiseptics for venous leg ulcers. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD003557. doi: 10.1002/14651858.CD003557.pub2.

  PMID: 18254024 BACKGROUND

• Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.

  PMID: 15183623 BACKGROUND

• Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.

  PMID: 29688123 BACKGROUND

• Bush R, Bush P. Percutaneous foam sclerotherapy for venous leg ulcers. J Wound Care. 2013 Oct;22(10 Suppl):S20-2. doi: 10.12968/jowc.2013.22.Sup10.S20.

  PMID: 24142137 BACKGROUND

Related Links

• Non-PubMed Citation: Terrie YC. Recognizing and Treating Venous Stasis Ulcers. US Pharm. 2017;42(2):36-39.
• Non-PubMed Citation: Gabriel A. Vascular ulcers. Medscape. http://emedicine.medscape.com/article/1298345-overview#a6. Accessed November 1, 2016.
• Non-PubMed Citation: Fishman TD, (2007). How to manage venous stasis ulcers. Podiatry Today. 20(5).

MeSH Terms

Conditions

Venous Insufficiency; Varicose Ulcer; Gastroesophageal Reflux; Ulcer

Interventions

Polidocanol; Radiofrequency Ablation; Sodium Tetradecyl Sulfate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Fatty Alcohols; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids

Study Officials

• Fedor Lurie, PhD, MD

  ProMedica Health System

  STUDY DIRECTOR

• Jihad Abbas, MD

  ProMedica Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fedor Lurie, PhD, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: After randomization is selected, no masking is required for this study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Vascular Surgeon, MD

Model Details: 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. 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.

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: December 1, 2022
• Study Start: September 30, 2020
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2024
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

US (1)