A portable on-demand therapeutic nitric oxide generation apparatus: New strategy for diabetic foot ulcers

Nitric oxide (NO) therapy has emerged as a promising intervention for diabetic foot ulcers (DFUs), though the application of this short-lived gas molecule presents substantial challenges. Direct delivery to the wound site and maintaining optimal NO concentrations are particularly difficult. Contemporary NO-based therapeutic strategies, while innovative, grapple with significant limitations. NO-donor based releasing materials are hindered by issues concerning biocompatibility, safety, and cost-effectiveness. In clinical practice, external NO therapy is still largely dependent on industrial NO gas cylinders, which is also problematic due to their size, lack of precision in monitoring, and limitations regarding gas sourcing. To overcome these obstacles, we have developed a novel portable on-demand therapeutic nitric oxide generation apparatus, referred to as the NO jet healing device (NJHD). This device is designed to produce NO safely and stably through a simple sodium nitrite/citric acid reaction. The integration of phase change sensor sampling technology allows for the real-time, high-precision monitoring of NO and nitrogen dioxide (NO2) concentrations, thereby ensuring the safety and reliability of clinical treatments. The therapeutic effectiveness of the NJHD has been assessed in both animal experiments and preliminary clinical trials involving DFU patients. Results have shown that NJHD treatment significantly accelerates the wound healing process, promoting angiogenesis, modulating inflammation, and enhancing collagen deposition at the wound site without causing adverse events in patients. These findings position the NJHD as an innovative medical technology with broad clinical applicability and significant future potential.