Venous DiseaseDillavouNCT03363633
Perforator Vein Injection for Symptomatic Venous Disease
A study testing sodium tetradecyl sulfate and Compression in people with Venous Disease, run by Ellen Dillavou at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Venous Disease
- What is being tested?
- sodium tetradecyl sulfate and Compression
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to 1 Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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)
Show all 11Show fewer
- Buergers disease
- Acute superficial thrombophlebitis
- Phlebitis migrans
- Acute cellulitis
- Clinical evidence of active local or systemic infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Shadyside Medical Building, Suite 307
Pittsburgh, Pennsylvania, 15232
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Disease
- Being tested
- sodium tetradecyl sulfate, Compression
- Keywords
- Venous Ulceration, Refluxing Perforator Veins
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium tetradecyl sulfateDrug
Ultrasound-guided injection with sodium tetradecyl sulfate foam of refluxing perforating veins
CompressionDevice
20-30 mmHg compression stockings
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Not described |
| Injection + Compression | Experimental | Not described Receives: Drug: sodium tetradecyl sulfate; Device: Compression |
| Compression | Active comparator | Not described Receives: Device: Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer Healing
Change in wound size, reported in square centimeters
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
Injection Complications
Number of participants experiencing venous thromboses from injections
Measured: 12 months
Compliance With Compression Therapy
Number of participants who use compression therapy
Measured: 12 months
Ulcer Recurrence
Number of participants with ulcers that reopen after initial closure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study startMar 2010
- Primary completion1 Oct 2010
- Study completion1 Oct 2010
Why it stopped: difficulty recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellen Dillavou
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Phlebology
- Responsible party
- Sponsor-investigator, Ellen Dillavou, University of Pittsburgh
- Investigators
- Ellen D Dillavou, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363633
- Sponsor's protocol ID
- Protocol #4
- Acronym
- Dillavou
- Status last verified
- Feb 2018
- First submitted
- 4 Jun 2017
- Last updated
- 23 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37497816
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Perforator Vein Injection for Symptomatic Venous Disease
- ClinicalTrials.gov ID
- NCT03363633
- Acronym / sponsor ID
- Dillavou / Protocol #4
- Conditions
- Venous Disease
- Keywords
- Venous Ulceration, Refluxing Perforator Veins
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ellen DillavouUniversity, hospital or other
- Collaborators
- American College of Phlebology
- Study start
- Mar 2010
- Primary completion
- 1 Oct 2010 (actual)
- Study completion
- 1 Oct 2010 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 23 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | – |
| Injection + Compression | Experimental | Drug: sodium tetradecyl sulfate, Device: Compression |
| Compression | Active comparator | Device: Compression |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • The subject must be > 18 years of age, male or female
- 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.
Key exclusion criteria (11 listed)
- • Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium tetradecyl sulfateUltrasound-guided injection with sodium tetradecyl sulfate foam of refluxing perforating veins | Drug | Injection + Compression |
| Compression20-30 mmHg compression stockings | Device | Compression, Injection + Compression |
Primary outcome
Ulcer Healing
Time frame: 12 months
Change in wound size, reported in square centimeters
4 secondary outcomes
Venous Clinical Severity Score (VCSS)
Time frame: 12 months
Injection Complications
Time frame: 12 months
Compliance With Compression Therapy
Time frame: 12 months
Ulcer Recurrence
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37497816Cai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen D Dillavou, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium tetradecyl sulfate and Compression in people with Venous Disease, run by Ellen Dillavou at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer Healing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03363633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018; AzTrials last refreshed its copy on 1 Nov 2026.