Using a diagnostic tool to identify elevated protease activity levels in chronic and stalled wounds: a consensus panel discussion.

Care of chronic and stalled wounds is hampered by the lack of diagnostic tools to help direct clinicians to specific treatments or diagnose specific conditions. Studies have shown a correlation between high protease levels and nonhealing wounds; a diagnostic protease test is under development. Seven wound care experts (two podiatrists, two vascular surgeons, a physician expert in hyperbaric oxygen therapy, a physical therapist with a specialty in home health, and a registered nurse) met to reach consensus on several aspects about a point-of-care protease test. They agreed that although disease states interfere with wound healing, such states do not automatically mean that wound healing will be impaired or that the wound becomes stalled after inception; and that patient comorbidities, patient factors, patient medications, and the microenvironment of the wound all affect the risk of nonhealing. They also agreed that: 1) appropriate protease activity was important in healing, 2) measuring just one individual protease would be unlikely to be representative of the proteolytic environment of the wound, 3) no diagnostic or theranostic tests to detect high protease activity levels in a wound is currently available, and 4) the development of a simple, widely available protease diagnostic test could dramatically change the provision of care, especially in outpatient settings. If subsequent research confirms that high protease activity levels delay healing, confirmation that a stalled wound has high protease activity levels could better target protease-modulating therapies and improve outcomes. Extensive validation of a protease test will be necessary from proof-of-concept pilot studies to controlled clinical trials to demonstrate that use of the test improves outcomes of care.