Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers

Inclusion Criteria: * Male or female patients aged over 18 years. * Diagnosed with type 1 or type 2 diabetes. * With a chronic (present for at least 6 weeks) full-thickness foot ulcer (on or below the malleoli) not penetrating to tendon, periosteum or bone, and with a cross-sectional area between 25 and 2500 mm2. * Patients must have pedal blood flow between normal and moderately ischaemic. Measurable as a palpable pedal pulse or in the absence of a palpable pedal pulse they must have a TcPO2 of ≥30mmHg or an ABPI of between 0.5-1.00, or \> 1.2. (An ABPI of \>1.2 is associated with calcification rather than ischaemia. We are including patients with an ABPI \>1.2 because ABPI is measured in large arteries. NOx has the ability to dilate medium to small arterioles which are less likely to be calcified.) * With some degree of neuropathy (as commonly seen in the Diabetes Foot Clinic). * Able to read and understand the Volunteer Information Sheet and to provide meaningful written informed consent. * Able and willing to follow the Protocol requirements. Exclusion Criteria: * Female patients who are pregnant or breast-feeding * Any other serious disease likely to compromise the outcome of the trial * Participation in any clinical study during the eight (8) weeks preceding the dosing period of the study * Wound area greater than 2500 square mm; * Patients with severe ischaemia. Measurable as absence of palpable pedal pulse and a TcPO2 of less than 30mmhg, or ABPI \< 0.5 or between …