Nitric oxide system shows promise in healing diabetic foot ulcers
A new wound care system using nitric oxide has been shown to heal diabetic foot ulcers faster and more effectively than standard care in UK treatment centres.
The principal investigator of the study Professor Michael Edmonds (King College Hospital, London) said, “Diabetic foot ulcers are notoriously hard to heal, and are the leading cause of diabetes-related amputations in the UK. Our findings provide an essential step forward in developing solutions for the effective management of these chronic wounds.”
The role of nitric oxide in ulcer healing involves three recognised elements:
- Vascular – nitric oxide influences the widening of blood vessels (vasodilatation) and stimulates the growth of new blood vessels (angiogenesis)
- Inflammatory – nitric oxide influences the body’s immune response
- Antimicrobial – nitric oxide demonstrates potent, broad spectrum antimicrobial activity
The new system EDX110 (Edixomed) provides a protective and cushioning layer that absorbs fluid while providing a moist environment and generating nitric oxide. EDX110 core technology provides sustained-release nitric oxide that can be delivered as a dressing, liquid, gel or inhaled spray, which has potential application in a variety of conditions and public health challenges, such as antimicrobial resistance.
Results from the pivotal clinical study, conducted in major UK treatment centres on 148 diabetic foot ulcers, showed that in 12 weeks, EDX110 reduced ulcer size by almost double the amount standard-of-care achieved (89% vs 47%). The new treatment also increased the number of completely healed ulcers by more than 50% (49% vs 30%), nearly doubled the complete healing of infected ulcers (45% vs 23%) and significantly reduced hospitalisations and serious adverse events related to the ulcer, compared with standard-of-care at 12 weeks. EDX110 is not yet an approved product.
The discovery that nitric oxide gas could play such an important role in the human body led to three scientists being awarded the Nobel Prize for medicine in 1998. The pioneering work demonstrated that the normal function of nitric oxide is to control blood flow in the small vessels in the skin and prevent the skin from being infected with dangerous organisms. Nitric oxide is also generated whenever the skin is injured or damaged and plays a crucial part in the normal skin healing process. However, in certain conditions, such as diabetes, the normal production of nitric oxide can be put at risk. The result is a chronic, poorly healing wound that is prone to infection. Replenishing the missing nitric oxide in such a way as to mimic the skin’s natural production has been a huge challenge to researchers.
Edmonds M et al. Multicenter, randomized controlled, observer‐blinded study of a nitric oxide generating treatment in foot ulcers of patients with diabetes – ProNOx1 study. Wound Repair and Regeneration 2018. doi:10.1111/wrr.12630.https://www.ncbi.nlm.nih.gov/pubmed/29617058
Edixomed website and ProNox1 study https://www.edixomed.com/pronox1-study-2/