Woundchek Protease Status for assessing elevated protease status in chronic wounds

The technology described in this briefing is the Woundchek Protease Status point-of-care diagnostic test. It is designed to qualitatively assess protease activity (the presence of which may impair healing) in chronic wounds.

The potential innovative aspect is that it is currently the only commercially available test that can detect whether a wound has an elevated protease status.

The intended place in therapy would be for use by clinical staff treating chronic wounds, to aid decision-making on wound dressings. Protease modulating dressings could be chosen for wounds where elevated protease status is detected. The test could be used in any care setting.

The key points from the evidence summarised in this briefing are from 4 studies involving 412 people. One published prospective, non-comparative study showed that elevated protease activity (EPA), detected with the Woundchek Protease Status test, was significantly associated with dermal graft failure in diabetic foot ulcers. The Woundchek Protease Status test had a high positive predictive value (80%) for non-healing status in chronic wounds in a further study. A randomised controlled trial in people with diabetic foot ulcers found that more wounds healed or improved in a group tested for EPA and treated with protease modulating dressings where appropriate, compared with standard care.

Key uncertainties around the evidence are that it is limited in quality and quantity. The published prospective study was small (n=35) and the other publications lacked detail because 2 were conference presentations on small studies and 1 was a research poster.

The Woundchek Protease Status test costs £30 per test and does not need maintenance or calibration. Kits with control samples and additional reagent are also available.

NICE has also published a medtech innovation briefing on the UrgoStart dressing for treating chronic wounds.