A 'test and treat' strategy for elevated wound protease activity for healing in venous leg ulcers

What are venous leg ulcers?

Venous leg ulcers are a common and recurring type of chronic wound. Compression therapy (bandages or stockings) is used to treat venous leg ulcers. Dressings which aim to protect the wound and provide an environment that will help it to heal are used underneath compression. Protease-modulating dressings are one of several types of dressing available.

Why use a test and treat strategy for venous leg ulcers?

Wounds that are slower to heal are thought to have higher levels of proteases (enzymes that break down proteins). Protease-modulating dressings are designed to lower protease activity and help wounds to heal. A test to detect high levels of protease activity has also been introduced. A 'test and treat' strategy involves testing for elevated proteases and then using protease-modulating treatments in ulcers which show elevated protease levels. It is important to know if using both the test and the treatment together can improve healing of leg ulcers.

What we found

In January 2016 we searched for as many relevant studies as possible that were randomised controlled trials, and which compared a 'test and treat' strategy with another treatment in people with venous leg ulcers. We did not find any eligible randomised studies. We found one ongoing study which might be relevant but could not obtain any more information on this. Research is still needed to find out if it is helpful to test venous leg ulcers for high levels of protease activity and then treat high levels using protease-modulating treatments. This review is part of a set of reviews investigating different aspects of using protease-modulating treatments in people with venous leg ulcers.

Authors' conclusions: 

Currently there is no randomised evidence on the impact of a test and treat policy for protease levels on outcomes in people with venous leg ulcers.


Read the full abstract...
Background: 

Venous leg ulcers are a common and recurring type of complex wound. They can be painful, malodorous, prone to infection and slow to heal. Standard treatment includes compression therapy and a dressing. The use of protease-modulating treatments for venous leg ulcers is increasing. These treatments are based on some evidence that a proportion of slow to heal ulcers have elevated protease activity in the wound. Point-of-care tests which aim to detect elevated protease activity are now available. A 'test and treat' strategy involves testing for elevated proteases and then using protease-modulating treatments in ulcers which show elevated protease levels.

Objectives: 

To determine the effects on venous leg ulcer healing of a 'test and treat' strategy involving detection of high levels of wound protease activity and treatment with protease-modulating therapies, compared with alternative treatment strategies such as using the same treatment for all participants or using a different method of treatment selection.

Search strategy: 

We searched the following electronic databases to identify reports of relevant randomised clinical trials: The Cochrane Wounds Group Specialised Register (January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) Issue 12, 2015); Ovid MEDLINE (1946 to January 2016); Ovid MEDLINE (In-Process & Other Non-Indexed Citations January 2016); Ovid EMBASE (1974 to January 2016); EBSCO CINAHL (1937 to January 2016). We also searched three clinical trials registers, reference lists and the websites of regulatory agencies. There were no restrictions with respect to language, date of publication or study setting.

Selection criteria: 

Published or unpublished RCTs which assessed a test and treat strategy for elevated protease activity in venous leg ulcers in adults compared with an alternative treatment strategy. The test and treat strategy needed to be the only systematic difference between the groups.

Data collection and analysis: 

Two review authors independently performed study selection; we planned that two authors would also assess risk of bias and extract data.

Main results: 

We did not identify any studies which met the inclusion criteria for this review. We identified one ongoing study; it was unclear whether this would be eligible for inclusion.

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