Perforator Vein Injection for Symptomatic Venous Disease

Study Overview
=================
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.

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.

Official Title
-----------------
Randomized Trial of Perforator Vein Injection for Symptomatic Venous Disease

Conditions
-----------------
Venous Disease

Intervention / Treatment
-----------------
* Drug: sodium tetradecyl sulfate
* Device: Compression


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous Ulceration, Refluxing Perforator Veins