Wound care is a major challenge for the healthcare system, affecting millions of people around the world and costing billions of dollars every year. Despite the availability of numerous products and therapies, the wound care industry is still plagued by inefficiencies, disparities, and unmet needs. In this post, we will examine some of the problems facing the wound care industry and highlight some of the emerging therapies that offer better patient outcomes, reduced cost/burden to health care systems, and hope for the future.
The Problem of Chronic Wounds
Chronic wounds are wounds that fail to heal within a normal time frame, usually due to underlying conditions such as diabetes, vascular disease, infection, or inflammation. Chronic wounds can have a devastating impact on the quality of life of patients, causing pain, disability, infection, amputation, and even death, yet many of the products and therapies available in the market are only modestly effective, expensive, or inaccessible to many patients. To understand the breadth of chronic wounds, an estimated 2.5% of the U.S. population suffers from chronic wounds, including diabetic foot ulcers, pressure injuries, leg ulcers, and others.[1]
Furthermore, the management of chronic wounds also imposes a significant economic burden on the health care system. According to a report by Fortune Business Insights, the global wound care market size was 18.51 billion USD in 2022 and is projected to grow to 30.04 billion USD by 2030.[2] However, this growth does not necessarily reflect improved outcomes or efficiency due to the limitations of existing products and therapies.
These limitations are due in part to the lack of consensus on the best practices and guidelines for wound assessment, diagnosis, treatment, and prevention. Contributing to this is a lack of reliable data and research on the clinical and cost-effectiveness of different wound care interventions. Compounding this effect is wide variability in the quality and availability of wound care services across different regions, settings, and providers.
This can easily be seen in the discrepancies in care across race and ethnicity. According to a study by McDermott et al., African Americans have a higher risk of developing diabetic foot ulcers and lower extremity amputations than whites.[3] This disparity may be due to factors such as socioeconomic status, access to health care, comorbidities, education level, and cultural beliefs. Contributing to this may be the lack of diversity and representation in wound care research and innovation, which may limit the development of products and therapies that are tailored to the needs and preferences of different populations.
Chronic wound research and innovation is underfunded and underrepresented, compared to other diseases. According to a report from Statista, the total funding for cancer research by the National Institutes of Health (NIH) for fiscal year 2022 was $7.6 billion.[4] Conversely, total NIH funding for wound healing research was 1/150th of that for cancer research.[5] In other words, cancer research received 150 times more funding than wound healing research, even though chronic wounds have a higher mortality rate than many types of cancer. For example, the five-year mortality rate after developing a diabetic ulcer is approximately 42% and up to 56.6% when lower extremity amputations are considered[6,7,8], while the five-year mortality rate for breast cancer is 10% and just 4% for prostate cancer.[9,10]
This neglect in funding and attention may reflect the lack of awareness and recognition of chronic wounds as a serious and prevalent health problem. Chronic wounds are often considered a secondary complication of other diseases, rather than a disease entity by itself. They are also often hidden or stigmatized by patients, which may reduce their demand for better care and advocacy. Thus, chronic wounds become overlooked by policymakers and funders, who prioritize other diseases that have more visibility or public appeal.
Therefore, there is a need for more investment and support for chronic wound research and innovation, which could lead to the development of solutions that improve the outcomes and quality of life of patients suffering from chronic wounds. There is also a need for more education and awareness among patients, caregivers, healthcare providers, policymakers, and funders about the burden and impact of chronic wounds and the potential benefits of effective wound care.
The Voice of Patients
Patients with chronic wounds are often frustrated and dissatisfied with their current treatment options and outcomes. They face many challenges and barriers in accessing quality wound care services and products. They also experience physical, emotional, social, and financial hardships due to their condition.
In April 2022, the U.S. Food and Drug Administration (FDA) held a public forum on wound healing, where patients with chronic wounds shared their stories and perspectives on their unmet needs and expectations from wound care products and therapies.[11] Common themes that emerged from their testimonies include:
The need for more effective products that can heal wounds faster and prevent complications such as infection and amputation.
The need for more affordable products that are covered by insurance or other sources of funding.
The need for more accessible products that are available in different settings such as home care or rural areas.
The need for more personalized products that are customized to their individual needs and preferences.
The need for more supportive products that can improve their quality of life and well-being.
These testimonies highlight the urgent need for a paradigm shift from wound management to wound healing. Patients with chronic wounds deserve better solutions that can address their pain points and improve their outcomes.
The Promise of Nitric Oxide
Nitric oxide (NO) is a naturally occurring molecule that plays a vital role in various physiological processes, where it influences vasodilation, inflammation, immunity, antimicrobial activity, and tissue regeneration.[12] Specific to wound healing, NO is also involved in the regulation of inflammation, cell proliferation, collagen formation, antimicrobial action and angiogenesis.[12]
However, the internal production of NO may be impaired in chronic wounds due to factors such as hypoxia, infection, oxidative stress, or reduced expression of NO synthase enzymes. Therefore, supplementing NO from external sources may be beneficial for enhancing wound healing. NO delivery systems have been developed to capture gaseous NO and release it in a controlled manner at the wound site.[12,13]
NO therapy for wound healing has several advantages over conventional therapies and can address the unmet needs and expectations of patients with chronic wounds. Some of these advantages are:
Effectiveness: NO can accelerate wound healing by improving blood flow, reducing inflammation, killing bacteria, and stimulating tissue growth.[12] NO-releasing biomaterials have shown positive results in various preclinical and clinical studies for chronic wound healing.[13] For instance, a systematic review of the therapeutic role of nitric oxide in diabetic wound healing reported that acidified nitrite increased dermal reconstruction, neovascularization, and collagen deposition; all of which contribute to accelerated wound healing.[14]
Affordability: NO therapy may be more cost-effective than conventional therapies because of its ability to catalyze faster healing by addressing multiple deficits commonly found in chronic wounds.[12,13] This presents an opportunity for standardization to one product that can serve the often varied and complex needs of patients with wounds, alleviating the need and cost of multiple products to manage each patient’s individual needs. Faster healing may reduce or alleviate direct costs, such as antibiotics, hospitalization, surgery, or amputation; as well as indirect costs, such as loss of productivity, disability benefits, or social services.
Accessibility: NO therapy is delivered locally and non-invasively using various biomaterials that can be applied in different settings, such as home care or rural areas. NO therapy can also be easily integrated with other treatment modalities such as debridement, compression therapy, or negative pressure wound therapy. Furthermore, NO therapy can be monitored remotely using telemedicine to optimize the dosage and frequency of application.
Personalization: NO therapy can be tailored to the individual needs and preferences of patients with chronic wounds by using different types of NO donors and delivery systems that can vary in their release kinetics, stability, biocompatibility, and biodegradability. NO therapy can also be customized to different wound types and conditions by adjusting the amount and duration of NO delivery according to the wound size, depth, contour, location, etiology, or oxygenation status
Supportiveness: NO therapy can improve the quality of life and well-being of patients with chronic wounds by reducing pain, odor, exudate, and dressing changes. Additionally, NO therapy can also improve the psychological and emotional aspects of wound care by enhancing patient satisfaction, confidence, self-esteem, and coping skills.
The Conclusion
The wound care field is facing many challenges and inefficiencies that limit its ability to provide optimal solutions for patients with chronic wounds. There is a need for more effective, affordable, accessible, personalized, and supportive products and therapies that can shift the paradigm from wound management to wound healing. Nitric oxide is one promising candidate that can meet these needs and offer better outcomes for patients and health care systems. Nitric oxide therapy has the potential to create a tectonic shift in wound care by harnessing the power of a natural molecule that can modulate various wound healing processes in a synergistic manner.
Contact: info@noxyhp.com
Sources:
[1] Sen, Chandan K. 2021. “Human Wound and its Burden: Updated 2020 Compendium of Estimates” Advances in wound care, 10, no. 5, 281, Mary Ann Liebert, Inc. doi:10.1089/wound.2021.0026
[2] Fortune Business Insights, 2021. “Wound Care Market Size & Growth/Research Report” https://www.fortunebusinessinsights.com/wound-care-market-103268
[3] McDermott, Katherine et al. “Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers.” Diabetes care vol. 46,1 (2023): 209-221. doi:10.2337/dci22-0043
[4] Statista. Total cancer funding by National Institutes for Health 2013-2024. Accessed on https://www.statista.com/statistics/716597/total-cancer-funding-by-the-national-institutes-for-health/.
[5] Tang, Xin et al. “Wound Healing Driver Gene and Therapeutic Development: Political and Scientific Hurdles.” Advances in wound care vol. 10,8 (2021): 415-435. doi:10.1089/wound.2019.1143
[6] Everett, Estelle, and Nestoras Mathioudakis. “Update on management of diabetic foot ulcers.” Annals of the New York Academy of Sciences vol. 1411,1 (2018): 153-165. doi:10.1111/nyas.13569
[7] Armstrong, David G et al. “Five-year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer.” Journal of foot and ankle research vol. 13,1 16. 24 Mar. 2020, doi:10.1186/s13047-020-00383-2
[8] Eaglstein, William H et al. “Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies.” Wound repair and regeneration: official publication of the Wound Healing Society [and] the European Tissue Repair Society vol. 20,6 (2012): 793-6. doi:10.1111/j.1524-475X.2012.00849.x
[9] Centers for Disease Control and Prevention. U.S. Cancer Statistics Prostate Cancer Stat Bite: 2020. Accessed on https://www.cdc.gov/cancer/uscs/about/stat-bites/stat-bite-prostate.htm
[10] Centers for Disease Control and Prevention. U.S. Cancer Statistics Breast Cancer Stat Bite: 2020. Accessed on https://www.cdc.gov/cancer/uscs/about/stat-bites/stat-bite-breast.htm
[11] U.S. Food & Drug Administration. Public Workshop: Wound Healing Scientific Workshop: 04/28-29/2022. Accessed on https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-fda-wound-healing-scientific-workshop-04282022
[12] Yu, Han et al. “Recent developments in nitric oxide-releasing biomaterials for biomedical applications.” Medical gas research vol. 9,4 (2019): 184-191. doi:10.4103/2045-9912.273956
[13] Malone-Povolny, Maggie J et al. “Nitric Oxide Therapy for Diabetic Wound Healing.” Advanced healthcare materials vol. 8,12 (2019): e1801210. doi:10.1002/adhm.201801210
[14] Chavhan, Mayur M et al. Therapeutic Role of Nitric Oxide in Diabetic Wound Healing: A Systematic Review. J. pharm. res. int. 33(33B): 68-80, 2021, doi:10.9734/JPRI/2021/v33i33B31798