ph diagnostics

The pH diagnostic program is an aid both detection of and assessment of wound infection

At present there are no rapid point-of-care diagnostic devices available for specific use in the evaluation of infection in chronic wounds. AGTS’s novel pH diagnostic targets a known area of unmet medical need and offers scope for improving clinical decisions and outcomes as current evaluations are based upon subjective visual assessments of the wound. AGTS’s pH diagnostic also provides scope to add value and cost-effectiveness data to existing cutting-edge Advanced Wound Care Products i.e. Growth factors (e.g. Regranex), ECM substitutes (e.g. Xelma) and Bioengineered products (e.g. Apligraf).

The aim of this program is to develop a product with the following target profile:

• Point-of-care diagnostic device which quickly displays wound pH colorimetrically as an aid in the detection of and assessment of wound infection
• The device provides objective guidance for the treatment of chronic wounds
• Low cost, simple to use & produces a rapid result
• Can be used in both community and clinic settings
• Convenient, non-invasive and well tolerated procedure

Status of development

• Currently in Phase I/II trials, involving 60 patients in 2 stages
• Clinical trial with prototype version of the diagnostic device currently on-hold following upgrading of device and application resubmitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA)
• MHRA have recently issued letter of ‘No Objection’ to enable the trial to recommence using enhanced version. Similar permission awaited from Ethics committee with trial to recommence imminently
• Production outsourced, trial samples produced