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Surrogate Endpoints Assist Leg Ulcer Treatment

Wound status after four weeks of treatment can provide valid surrogate markers for healing of venous leg ulcers at 12 or 24 weeks of care.

The markers are log healing rate, log wound area ratio and percentage change in wound area, say researchers at the Department of Dermatology and the Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, United States.

The surrogate markers are considered valuable because they can predict the meaningful clinical endpoint of treatment well before the true outcome can become evident.

This is useful with venous leg ulcers, the researchers say, because evaluation of therapies is challenged by the long observation period needed to reach the endpoint of healing.

Surrogate markers for venous leg ulcer healing might help to make early clinical trials more efficient. They might also allow clinicians to identify patients who are unlikely to heal early. That would expedite referral to specialty centres or assist the selection of stepped treatment algorithms.

The researchers examined wound healing characteristics as candidate surrogate markers of venous leg ulcer healing by analysing 56,488 wounds in 29,189 patients.

Median wound size was 189 mm2, with a median wound duration of three months.

The three surrogate markers were further validated by demonstrating that established risk factors for not healing, such as wound size and wound duration, were also important risk factors for not achieving the surrogate endpoint.
Journal of Investigative Dermatology 2002;119(6):1420-1425. "Surrogate endpoints for the treatment of venous leg ulcers."

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