NCT03363633

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 23, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

7 months

First QC Date

June 4, 2017

Results QC Date

December 18, 2017

Last Update Submit

February 21, 2018

Conditions

Venous Disease

Keywords

Venous UlcerationRefluxing Perforator Veins

Outcome Measures

Primary Outcomes (1)

  • Ulcer Healing

    Change in wound size, reported in square centimeters

    12 months

Secondary Outcomes (4)

  • Venous Clinical Severity Score (VCSS)

    12 months

  • Injection Complications

    12 months

  • Compliance With Compression Therapy

    12 months

  • Ulcer Recurrence

    12 months

Study Arms (3)

Observation

NO INTERVENTION

Injection + Compression

EXPERIMENTAL
Drug: sodium tetradecyl sulfateDevice: Compression

Compression

ACTIVE COMPARATOR
Device: Compression

Interventions

sodium tetradecyl sulfateDRUG

Ultrasound-guided injection with sodium tetradecyl sulfate foam of refluxing perforating veins

Injection + Compression
CompressionDEVICE

20-30 mmHg compression stockings

CompressionInjection + Compression

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shadyside Medical Building, Suite 307

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

  • Cai PL, Hitchman LH, Mohamed AH, Smith GE, Chetter I, Carradice D. Endovenous ablation for venous leg ulcers. Cochrane Database Syst Rev. 2023 Jul 27;7(7):CD009494. doi: 10.1002/14651858.CD009494.pub3.

    PMID: 37497816DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Sodium Tetradecyl Sulfate

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fatty AlcoholsAlcoholsOrganic ChemicalsAlkanesulfonatesAlkanesulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsLipids

Results Point of Contact

Title
Ellen D. Dillavou, MD, FACS
Organization
Duke University Medical Center
ellen.dillavou@duke.edu

Study Officials

  • Ellen D Dillavou, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2017

First Posted

December 6, 2017

Study Start

March 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 23, 2018

Results First Posted

February 23, 2018

Record last verified: 2018-02

Locations

US(1)