RCT protocol development to evaluate MPPT in venous leg ulcers

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"The main reason wounds and ulcers have difficulty or fail to heal is infection. For the past decade, it has been standard medical practice to use antimicrobials to treat wound infections, but several clinical studies have shown that they have minimal effects and NICE and the FDA no longer encourage their use. Furthermore, both antibiotics and antiseptics strongly contribute to the creation of antimicrobial resistance, a global health problem.Micropore particle technology (MPPT) is a novel approach which acts as a passive immunotherapy for wound infection and healing. MPPT disrupts the weaponry bacteria and fungi use against the immune system with the result that the immune system regains control of the wound and the wound healing process. In a comparative clinical study MPPT removed wound infections and initiated healing 60% quicker than an antibiotic and an antiseptic and it reduced the number of hospitalisation days by 31%. Annually in the UK alone, 2.2 mill wounds require treatment causing direct costs to the NHS of £5.3 bn. Estimates indicate that MPPT can reduce the costs of wound care by 21% and can assist many patients who are strongly affected by wounds. MPPT is patented and expected to meet a global unmet clinical need. MPPT is not antimicrobial and will not contribute to the creation of resistance.A key factor in supporting the introduction of a new healthcare technology is to obtain an appraisal from NICE, which evaluates all data and offers an opinion on the health benefits of the approach. The purpose of this project is to prepare the first phase towards receiving such an appraisal. Once achieved, this will be used to support the introduction of the technology in the UK as well as to support export efforts as NICE recommendations are closely stuied in most countries worldwide."