A Registry-based Study Assessing the Efficacy of a Nitric Oxide Delivering Foam for Wound Healing

Introduction: In healthy adults, nitric oxide (NO) is produced in sufficient amounts but is reduced in elderly, sick, or obese people, which delays wound healing.1,2 Nitric oxide is a highly diffusible, endogenous vasodilator, antimicrobial, and cell signaling molecule. Nitric oxide also modulates hemostasis, inflammation, immune response, debridement, matrix metalloprotease, perfusion, angiogenesis, collagen synthesis, granulation formation, wound contraction, epithelialization, and reduced scarring1-3; all processes necessary for effective wound healing. Despite NO’s known benefits, there were no available nitric oxide delivering products available for wound treatment prior to introduction of the study product.  The aim of this project was to assess the effectiveness of a first-of-its-kind topical nitric oxide-delivering foam for wound healing.Methods:A research protocol, data collection form, and informed consent were developed. A data registry was designed to automate the data collection form. Product and data registry training was provided to facility staff by facility leadership. A topical nitric oxide delivering foam was implemented in skilled nursing facilities across California. Clinical case patient selection for product use was guided by physician judgement. Clinical cases were entered by facility staff. Data collected included healthcare provider demographics, patient demographics, wound and treatment history, and wound assessment and treatment details. Data were analyzed in aggregate form.Results:To date, 79 clinical cases have been logged into the data registry from 13 facilities. Etiologies represented include pressure injuries, arterial ulcers, venous leg ulcers, skin tears, and abrasions, among others. Across all wound etiologies 81% (n=79) wounds in the registry healed in a mean treatment time of 14 days. 100% of the stage 3 pressure injuries (n=5) healed in a mean treatment time of 22.8 days. One arterial ulcer healed in 22 days and a large 15 cm2 arterial ulcer reduced in size by 80% in 30 days. Furthermore, 85.7% (n=14) deep tissue pressure injuries resolved in a mean treatment time of 15 days and 80% (n=5) unstageable pressure injuries healed in a mean treatment time of just 9 days.  Discussion: Data collection is ongoing, but this data demonstrates that the topical nitric oxide-delivering foam catalyzed timely wound healing across various wound etiologies and severities of injury.References:1. Goedeke, R. (2024). Decoding the Benefits of Nitric Oxide for Skin Health: A New Horizon in Dermatology. Available at https://www.biospherenutrition.co.nz/blogs/nitric-oxide/decoding-the-benefits-of-nitric-oxide-for-skin-health-a-new-horizon-in-dermatology. 2. Rocha B. S. (2021). The Nitrate-Nitrite-Nitric Oxide Pathway on Healthy Ageing: A Review of Pre-clinical and Clinical Data on the Impact of Dietary Nitrate in the Elderly. Frontiers in aging, 2, 778467. https://doi.org/10.3389/fragi.2021.778467 3. Poh, W. H., & Rice, S. A. (2022). Recent Developments in Nitric Oxide Donors and Delivery for Antimicrobial and Anti-Biofilm Applications. Molecules (Basel, Switzerland), 27(3), 674. https://doi.org/10.3390/molecules27030674