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Ultrasound-Guided Injection of Polidocanol Microfoam in the Management of Venous Leg Ulcers
Juan Cabrera, MD, PhD;
Pedro Redondo, MD, PhD;
Antonio Becerra, MD;
Celia Garrido, MD;
Juan Cabrera, Jr, MPharm;
María Antonia García-Olmedo, MPharm;
Alejandro Sierra, MD, PhD;
Pedro Lloret, MD;
Miguel A. Martínez-González, MD, PhD, MPH
Arch Dermatol. 2004;140:667-673.
Background Venous leg ulceration is a frequent and severe complication of lower limb venous insufficiency. Compression therapy is associated with a protracted course of healing and multiple recurrences. Minimally invasive surgery (subfascial endoscopic perforating surgery) is only possible in a subset of patients with leg ulcers. Low-cost and noninvasive therapeutic procedures are needed as alternative treatments.
Objective To evaluate the efficacy and safety of sclerosant in microfoam in treating venous leg ulceration.
Design A retrospective study of medical records, pretreatment and posttreatment color photographs, and echo Doppler in patients with venous leg ulceration. All patients were evaluated at 6 months after therapy, 70% were also evaluated at 2 years, 25% at 3 years, and 14% at 4 or more years after treatment. They were assessed for complete (100%) ulcer healing, time to wound closure, and recurrence.
Setting Private vascular surgery clinic in Granada and dermatology department at a hospital in Pamplona, Spain.
Patients Over 115 months, 116 consecutive patients (mean age [range], 57 [25-85] years) treated with ultrasound-guided injection of polidocanol microfoam (UIPM).
Interventions To reduce venous hypertension, UIPM was used to selectively and progressively sclerose sources of incompetence. The number of sessions per patient varied between 1 and 17 (mean, 3.6).
Main Outcome Measures Complete ulcer healing, defined as full reepithelialization of the wound with absence of drainage. Recurrence was defined as epithelial breakdown in the healed limb.
Results At 6-months' follow-up, treatment with UIPM achieved complete healing in 83% of patients (96/116), with median time to healing of 2.7 months; 7 patients were never cured, and 1 patient was lost to follow-up. There were recurrences in 10 patients.
Conclusions The use of UIPM to selectively and progressively sclerose incompetent veins produced by venous hypertension is highly effective to achieve a stable ulcer healing with minimal invasion, even in elderly patients. Recurrences are easily treatable with this approach. This technique may become a first-line treatment in the management of leg venous ulcers.
From the Vascular Surgery Clinic, Granada, Spain (Drs J. Cabrera, Becerra, and Garrido, Ms García-Olmedo, and Mr J. Cabrera Jr); and Departments of Dermatology, University Clinic (Drs Redondo, Sierra, and Lloret), and Epidemiology and Public Health (Dr Martínez-González), Medical School, University of Navarra, Pamplona, Spain. Dr J. Cabrera and Mr J. Cabrera, Jr have a financial interest in the commercial development of the patented microfoam. The microfoam presented in the study was made the subject of a patent application by the authors in 1993, and they have subsequently assigned the patents to BTG International Limited. Provensis Ltd, a subsidiary of BTG, has developed the patented microfoam concept into a pharmaceutical product, Varisolve, which is currently used in clinical trials in Europe and the United States.
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