Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers

Inclusion Criteria: * Patients with superficial venous and mixed aetiology leg ulcers on a flat plane in surface area between 4-50cm2 * Patients with diabetes may be included providing they have good metabolic control * Patients who understand the trial, agree to adhere to the treatment and are able to give consent * Patients who can be followed by the same investigating team for the whole period of their participation in the study Exclusion Criteria: * Patients who present with wounds which are clinically infected and require antimicrobial therapy. Patients who have been treated for a wound infection with antimicrobial therapy (systematically or topically) may be included providing the wound is no longer assessed as infected and there is a two week wash-out period after the last treatment before the patient is reassessed against the inclusion and exclusion criteria * Patients with a known sensitivity to any of the components of the evaluation device * Patients with known or suspected malignancy in the wound or surrounding tissue * Patients whose wounds show a percentage decrease in surface area of \>25% during the two week screening period * Patients who do not have the physical or mental capacity, or a significant other with the ability to change the NatroxTM battery pack on a daily basis * Patients who present with more than 10% of the wound surface area covered in hard eschar * Patients who are actively treated with immunosuppressive or cortico-steroidal medication * Patients who are participating in another clinical trial * Patients with a known history or poor compliance with medical treatment * Patients who have been in this trial previously and have withdrawn * Patients who are unable to understand the aims of the trial and do not give informed consent