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Perforator Vein Injection for Symptomatic Venous Disease (Dillavou)

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ClinicalTrials.gov Identifier: NCT03363633
Recruitment Status : Terminated (difficulty recruiting)
First Posted : December 6, 2017
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
American College of Phlebology
Information provided by (Responsible Party):
Ellen Dillavou, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Venous Disease Drug: sodium tetradecyl sulfate Device: Compression Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Perforator Vein Injection for Symptomatic Venous Disease
Study Start Date : March 2010
Actual Primary Completion Date : October 1, 2010
Actual Study Completion Date : October 1, 2010

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Ulcer Healing [ Time Frame: 12 months ]
    Change in wound size, reported in square centimeters


Secondary Outcome Measures :
  1. Venous Clinical Severity Score (VCSS) [ Time Frame: 12 months ]
    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.

  2. Injection Complications [ Time Frame: 12 months ]
    Number of participants experiencing venous thromboses from injections

  3. Compliance With Compression Therapy [ Time Frame: 12 months ]
    Number of participants who use compression therapy

  4. Ulcer Recurrence [ Time Frame: 12 months ]
    Number of participants with ulcers that reopen after initial closure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363633


Locations
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United States, Pennsylvania
Shadyside Medical Building, Suite 307
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Ellen Dillavou
American College of Phlebology
Investigators
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Principal Investigator: Ellen D Dillavou, MD University of Pittsburgh

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Responsible Party: Ellen Dillavou, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03363633     History of Changes
Other Study ID Numbers: Protocol #4
First Posted: December 6, 2017    Key Record Dates
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018
Last Verified: February 2018

Keywords provided by Ellen Dillavou, University of Pittsburgh:
Venous Ulceration
Refluxing Perforator Veins

Additional relevant MeSH terms:
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Sodium Tetradecyl Sulfate
Sclerosing Solutions
Pharmaceutical Solutions