Malignancy and Chronic Leg Ulcers: The Value of Systematic Wound Biopsies: A Prospective, Multicenter, Cross-sectional Study

Objective To determine the frequency of skin cancers associated with chronic leg ulcers (CLUs) presumably of vascular origin and failing to heal (ie, increased wound area or depth) despite 3 months or more of appropriate treatment. Design Prospective cross-sectional study. Setting Ambulatory or hospitalized patients from 17 dermatology departments. Patients Between January 1, 2006, and May 31, 2008, a total of 144 patients consulted for CLUs, attributed to venous and/or peripheral arterial disease(s), increasing in wound size, that is, larger area and/or depth, despite appropriate standard treatment for at least 3 months. Main Outcome Measures At inclusion, at least two 6-mm punch biopsies, 1 at the wound edge and 1 in the wound bed, in the most clinically suspicious areas, were systematically performed. The primary end point was the skin cancer frequency diagnosed in at least 1 wound biopsy specimen obtained at inclusion. Results The 144 patients included had 154 CLUs. The overall skin cancer frequency in the CLUs was 10.4%: 9 squamous cell and 5 basal cell carcinomas, 1 melanoma, and 1 leiomyosarcoma; 56.3% had persisted for at least 3 years. Univariate analyses retained older age, abnormal excessive granulation tissue at wound edges, high clinical suspicion of cancer, and number of biopsies, but not wound area or duration, as being significantly associated with skin cancer in 1 or more biopsy specimens. Conclusions The combined primary ulcerated cancer or malignant transformation frequency was sufficiently high in CLUs referred to tertiary care centers to consider systematic biopsy of a wound refractory to 3 months or more of appropriate treatment. Trial Registration clinicaltrials.gov Identifier: NCT 00709631