ProNOx 5: NOx Dressing for Healing of Venous Leg Ulcers
Research type
Research Study
Full title
ProNOx 5: A Clinical Study of a Nitric Oxide Generating Dressing for Treatment of Venous Leg Ulcers.
IRAS ID
185189
Contact name
Joanne Stewart
Contact email
Sponsor organisation
Edixomed Ltd
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
We propose to conduct a clinical pilot study of our nitric oxide (NOx) generating dressing system (NOx gel dressing) for treatment of venous leg ulcers (VLUs). The simple two-layer system provides a conformable, cushioning dressing, able to manage wound exudate, and which, upon contact, releases nitric oxide to the wound.
A multi-centre, UK-wide, 120 patient study has recently completed recruitment in patients with diabetic foot ulcers. The dressing has demonstrated an ability to improve blood flow, control infection and promote wound healing.
Venous leg ulceration affects approximately 1-1.5 % of adults in developed countries at some point in their lives. Despite optimisation of treatment protocols, these ulcers are associated with a high incidence of failure to heal and recurrence, with up to 50 % of ulcers remaining open and unhealed for up to 9 months. National Clinical Guidelines (the Scottish Intercollegiate Guidelines Network, 2010) for specific management of leg ulceration currently state that, as yet, “no specific dressing has been shown to improve healing rates”
Our system delivers exogenous NOx to the localized area of the wound bed, restoring NOx levels to the tissues, to re-establish some of the normal physiological conditions. Our product represents an opportunity to provide a meaningful treatment option for patients with hard to heal wounds.
The current study will assess the compliance, safety and tolerability of the dressing system in the new indication for VLUs. It should give some indication of potential to heal these types of wounds. Assessments of wound measurement will be performed by digital photography and wound planimetry using the 3D Silhouette camera system (Aranz Medical).This study will be conducted with the co-operation of three, geographically close centres in the UK: Bradford Institute for Health research, Hull Royal Infirmary, and Leeds General Infirmary.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0399
Date of REC Opinion
21 Dec 2015
REC opinion
Further Information Favourable Opinion