Perforator Vein Injection for Symptomatic Venous Disease (Dillavou)

Randomized Trial of Perforator Vein Injection for Symptomatic Venous Disease

The primary objective of this study is to compare two treatment strategies for symptomatic venous stasis disease with and without venous ulcer. These treatments are compression therapy alone vs. sclerotherapy of refluxing perforating veins with compression.

Study Overview

• Status: Terminated
• Conditions: Venous Disease
• Intervention / Treatment: Drug: sodium tetradecyl sulfate; Device: Compression

Detailed Description

Symptomatic venous disease is a widespread problem, affecting millions of patients per year, an estimated 1.0 - 1.5% of the population. This costs up to 1% of the total health care budget1-3. Venous problems account for almost 3000 patient visits in the UPP vascular surgery group per year. Although great progress has been made in venous stasis treatments there are still patients who suffer for many years with pain and ulceration due to venous disease. The investigators believe that venous hypertension is the underlying cause of venous ulceration. Three mechanisms leading to venous hypertension are well-recognized: superficial vein (great, accessory and small saphenous) incompetence; deep vein (common and superficial femoral, popliteal and tibial) reflux or obstruction; perforating vein incompetence. Patients with venous stasis and ulceration may have any or all of these conditions. Currently there are excellent treatments for superficial venous reflux, namely laser or radiofrequency ablation. Deep venous reflux therapy is still under investigation, with prosthetic valves in trial. However, compression is still the mainstay of therapy. The presence of deep venous reflux has been shown to have a significant effect on ulcer healing when perforator treatment has been investigated4. Refluxing perforator vein treatment is currently in flux, with the existing options of open surgery and subfascial endoscopic perforator surgery (SEPS) being the most tested options, but with significant wound complications and long hospital stays associated with both7. The investigators are proposing a prospective trial to evaluate percutaneous perforator thrombosis to achieve similar results with less morbidity.

The population targeted is patients with venous stasis or ulceration who either do not have demonstrable superficial reflux amenable to ablation, or have venous symptoms and ulceration despite treatment of incompetent superficial veins. When patients have refluxing perforating veins, there is debate on optimal treatment. Open and endoscopic ligation and compression therapy have all been tried with varying degrees of success and morbidity. The average rate of healing in venous ulcers is approximately .05 cm/wk 5,6, which has been shown to significantly improve after perforator ligation4, but with high morbidity. Ultrasound-guided injection of perforating veins is now performed, but with largely unknown benefits and consequences. The investigators propose a prospective, randomized trial of perforator injection with sodium tetradecyl sulfate (STS) foam vs. compression as a means of determining the efficacy and morbidity of perforator STS foam injection for symptomatic venous disease. The investigators currently utilize both methods of treatment in practice. Injections and compression or compression alone are chosen based on each patient's clinical scenario. STS is currently approved by the U.S. Food and Drug Administration for intravenous use.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Shadyside Medical Building, Suite 307

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • The subject must be > 18 years of age, male or female

  • Subject must be willing and able to wear compression stockings
  • Subject must have refluxing perforating veins ≥ 3.0 mm in diameter at the calf level or distally in the affected leg.
  • Subject presents with ulceration or other symptoms of venous stasis including:

rash, swelling, pain, bleeding, recurrent cellulitis

• The subject must sign a written informed consent, prior to randomization, using a form that is approved by the local Institutional Review Board.

Exclusion Criteria:

• • Pregnancy

  • Known allergy to STS
  • Refusal to wear compression stocking
  • Untreated significant great or small saphenous reflux
  • Disseminated malignancy or other terminal condition where subject is expected to live less than 6 months.
  • Significant arterial disease (ABI < .8)
  • Buergers disease
  • Acute superficial thrombophlebitis
  • Phlebitis migrans
  • Acute cellulitis
  • Clinical evidence of active local or systemic infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observation
Experimental: Injection + Compression	Drug: sodium tetradecyl sulfate; Ultrasound-guided injection with sodium tetradecyl sulfate foam of refluxing perforating veins; Device: Compression; 20-30 mmHg compression stockings
Active Comparator: Compression	Device: Compression; 20-30 mmHg compression stockings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ulcer Healing	Change in wound size, reported in square centimeters	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous Clinical Severity Score (VCSS)	The VCSS includes nine criteria of chronic venous disease, each graded from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Up to three points may be added for differences in background conservative therapy (compression and elevation). The scores are then added, with a maximum score of 30.	12 months
Injection Complications	Number of participants experiencing venous thromboses from injections	12 months
Compliance With Compression Therapy	Number of participants who use compression therapy	12 months
Ulcer Recurrence	Number of participants with ulcers that reopen after initial closure	12 months

Collaborators and Investigators

• Sponsor: Ellen Dillavou
• Collaborators: American College of Phlebology
• Investigators: Principal Investigator: Ellen D Dillavou, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: June 4, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Venous Ulceration; Refluxing Perforator Veins
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Sclerosing Solutions; Sodium Tetradecyl Sulfate
• Other Study ID Numbers: Protocol #4