Effect of PEM Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound He… (NCT02988063) | Clinical Trial Compass
WithdrawnPhase 4
Effect of PEM Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in VLUs
Stopped: Poor enrollment
United States0Started 2017-04-10
Plain-language summary
This study evaluates the addition of polidocanol endovenous microfoam (PEM) to compression therapy to determine effectiveness in improving the healing of venous leg ulcers (VLUs) in adults with severe venous disease of the great saphenous vein (GSV). All participants will receive treatment with Varithena and compression therapy.
The purpose of this study is to assess whether the use of PEM to correct superficial axial and varicose vein reflux is effective in improving healing of VLUs, over treatment with compression alone.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old
* Active VLU with a CEAP classification of C6
* Non-healing VLU ≥ 1 month but not greater than 24 months
* In the case of more than one ulcer, the largest ulcer (compliant with study criteria) will be chosen as the study ulcer and treated in the study. Other ulcerations, if present on the same leg must be at least 2cm apart from the study ulcer.
* Demonstrable GSV insufficiency (as per the Society for Vascular Surgery \[SVS\] and the American Venous Forum \[AVF\] Guidelines) via venous insufficiency study (VIS) (11)
* VLU considered non-healing (clinically defined as ≤70% wound improvement) after a 4-5 week run-in period with compression therapy
* Venous leg ulcer size ≥ 2cm2 within the great saphenous distribution and must be visualized in one plane to allow for image collection of the entire wound in one photo by the Silhouette device.
* The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone
* The ulcer must be located below the knee
* The ulcer bed must have some viable tissues with some granulation tissue
* Able to tolerate effective compression bandaging
* Patients able to walk independently with or without mobility aids
* Ability to comprehend and sign an informed consent document and complete study questionnaires in English
* Able and willing to attend all follow up visits
Exclusion Criteria:
* Age \< 18 years old
* Small saphenous vein (SSV) distribution VLUs
* Patients who had previously…