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Revolutionary wound treatment for foot ulcers
Ark Therapeutics plc is seeking a suitable Japanese partner for their product 'Kerraboot'. It is already CE marked in Europe and has been listed with the FDA, allowing it to be marketed in the US. Marketing has just started in the UK.

Kerraboot® (EG008) – wound dressing device

Kerraboot® is a novel wound dressing device for leg and foot ulcers. It is CE marked in Europe and has been listed with the FDA, allowing it to be marketed in the US. In May 2004 UK Drug Tariff Approval was obtained and GPs are now prescribing it.

Kerraboot® is marketed as a novel wound dressing device for the management of leg and foot ulcers, offering significant benefits in terms of savings of nurse time, less painful procedure on dressing changes and reduction of odour. In assessment programmes carried out by Ark, both patients and healthcare workers rated Kerraboot® significantly better than alternative dressings It was also considered easy to use and very convenient. The time taken to change the device was approximately 70% less than that required to change a conventional dressing. Kerraboot® also caused less pain on changing than conventional dressings and the need to remove calluses from around the ulcers was reduced. It largely eliminated unpleasant ulceratic odours. Favourable effects in terms of healing were demonstrated and, in particular, significant healing was seen in ulcers associated with diabetes. No significant adverse reactions relating to the product were observed.

Clinical condition - Leg and foot ulcers generally present as open sores, and frequently become infected, causing a strong, unpleasant and embarrassing odour. They are difficult to heal and in the most severe cases can lead to amputation. They can be caused initially by local problems in blood vessels or nerve damage and are frequently associated with patients who suffer from diabetes. Hospital treatment of the ulcer can include regular removal of surrounding hard skin build-up (callus) and often painful redressing of the ulcer by a trained healthcare professional up to three times a day.

Mechanism of action - Fluid from leg and foot ulcers, known as exudate, contains substances which inhibit natural growth factors (notably VEGF) from healing the wound. Kerraboot® works by soaking up and isolating the exudate, whilst maintaining a warm, moist and protected environment around the ulcer. This combination facilitates growth of healthy new blood vessels and tissue in the ulcer bed and limits the formation of calluses. Healthy new vascular tissue helps to fight infection and promotes healing of the skin.

Commercialisation - Kerraboot® has been launched in the UK using a small contracted salesforce. Commercial options for the US and other European markets are currently being explored. In smaller European countries and ROW territories such as Japan Ark expects to out-licence Kerraboot® to existing distributors or companies currently promoting wound care or foot related products.

Estimated market - There is a total market of 1.3 million diabetic and venous leg and foot ulcer sufferers in the US and Europe. Ark is initially targeting the diabetic market and patients with venous ulcers who cannot tolerate the standard treatment of compression bandaging, of whom there are approximately 620,000 patients in the US and Europe. The venous leg ulcer market is twice as large as the diabetic market in terms of patient numbers, and there is an existing demand for better dressings in a significant proportion of cases. Trial results have indicated that both healthcare workers and patients consider Kerraboot™ offers a significant benefit over current wound management approaches.

Additional Information

Product Brochure: English version | Japanese version

Abstract ‘Management of neuropathic and neuroischaemic leg and foot ulcers: A preliminary assessment of a novel wound dressing device; the Kerraboot®'

Abstract ‘Healing of Neuropathic Foot Ulcer using a Novel ‘Wound Boot’ (Kerraboot®)'

• Please contact us for copies of the following:

‘The Kerraboot®: A novel wound dressing device for the management of leg and foot ulcers’ by R Leigh, S Barker; N Murray, SJ Hurel (Practical Diabetes International January/February 2004 Vol. 21 No. 1).

‘Moist wound healing: a review of evidence, application and outcome’ by Debbie Sharman (The Diabetic Foot, Autumn 2003 Vol. 6 No. 3)

‘Malodorous wounds – taking the patient’s perspective into account’ by A. Hack (Journal of Wound Care, September 2003, Vol. 12, No. 8)