British wound care company starting clinical trials to bring tests to U.S.

Woundchek Laboratories, a British developer of diagnostic tests that gauge a wound’s severity and its ability to heal, plans to soon begin U.S. clinical trials.The goal is Food and Drug Administration clearance so it can market its products stateside. It is working with the SerenaGroup network of 20 clinics to complete two clinical trials this year, […]

Woundchek Laboratories, a British developer of diagnostic tests that gauge a wound’s severity and its ability to heal, plans to soon begin U.S. clinical trials.The goal is Food and Drug Administration clearance so it can market its products stateside.

It is working with the SerenaGroup network of 20 clinics to complete two clinical trials this year, testing a couple of chronic wound care tests.

The company is hoping to get approval for its Bacterial Status test, which assesses how likely the bacteria in chronic wounds are to cause infection, and its Protease Status test, which gauges how healable infected wounds are.

Elevated protease activity (EPA) is an indicator that wounds are less likely to heal. A chronic wound with EPA has a 90 percent chance of not healing without appropriate intervention. Also, chronic wounds with EPA are more likely to have graft failure than chronic wounds with low protease activity, studies have found – and that a diagnostic test could potentially help determine the appropriate wound care treatment. Woundchek’s protease test, which is approved already in Europe, the Middle East and South Africa, is the first of its kind, the company said.

Its bacterial tests gauge bacterial pathogenesis, which is a precursor to the clinical signs and symptoms of infection, indication whether or not a chronic wound needs further medical intervention.

“Currently, the cost of ineffective treatment is estimated to be $20-25 billion annually,” CEO Jack Wilkens said in a statement. “We believe that our efforts so far over the past 5 years and the clinical trials planned this summer bring us closer than ever to introducing wound diagnostics to the US market.”

[Image of a covered-up wound courtesy of Flickr user cnycompguy]