The latest research findings for cancer, heart disease, and diabetes perpetually grab the spotlight, but now, under-the-radar conditions, such as non-healing chronic wounds, are being recognized. Considering that they affect millions of Americans, including approximately 8.2 million Medicare beneficiaries1, with projected annual costs ranging from $28.1 to $96.8 billion, this condition deserves attention. Recently, the Food and Drug Administration (FDA) identified non-healing chronic wounds as a high unmet medical need that warrants prioritization.2
As described in our latest white paper, Accelerate Chronic Wound Research Through Real World Data (RWD), Technology and Patient Engagement, research in chronic wounds is ramping up and becoming an increasingly important product category for product and device manufacturers.
In addition to clinical trials, there are more retrospective studies, which analyze RWD mined from large databases. FDA defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources,”3 such as electronic health records (EHR), medical claims data, and more. In 2021, FDA released four drafts with guidance on this subject.
What is a Non-Healing Chronic Wound?
This type of wound has not progressed through the normal healing process, is open for more than a month4, and has failed to close.
To measure the growing number of non-healing chronic wounds, researchers are increasingly relying on RWD, primarily fueled by breakthrough technology that makes measuring wounds easier, more accurate, and more engaging for patients. Tissue Analytics offers a secure, easy-to-use smartphone app that patients can download and use to take high-quality pictures of wounds that are sent immediately to the clinician’s dashboard. Then, the system automatically traces and measures the wound via cloud-based analysis and uploads the information into an EHR. These RWDs can become part of databases available for retrospective studies.
Significantly, this type of automated platform dramatically improves the accuracy of wound measurement. Traditionally, wounds were measured by paper rulers, but the error rate was 44%. In contrast, with the latest technology, the error rate drops to 4%.5
As for patient engagement, the app can produce a “film strip,” a unique feature that illustrates wound closure progression throughout a study, helping the patient feel connected and possibly boosting retention.
Discover How Technology Can Transform Wound Care Research
1Nussbaum SR, Carter MJ, Fife CE, Haught R, et al. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Value in Health. 2018;21(1):27-32.
2Wound Healing Scientific Workshop; Public Workshop; Request for Comments. A Notice by the Food and Drug Administration. Federal Register. December 20, 2021. Available at: https://www.federalregister.gov/documents/2021/12/20/2021-27459/wound-healing-scientific-workshop-public-workshop-request-for-comments.
3Real-World Evidence. Food and Drug Administration. May 20, 2022. Available at: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence#:~:text=Real%2Dworld%20data%20are%20the,Product%20and%20disease%20registries.
4Sen CK. Human Wound and Its Burden: Updated 2020 Compendium of Estimates. Advances in Wound Care. 2021;10(5):281-92. Available at: https://www.liebertpub.com/doi/10.1089/wound.2021.0026.
5Seat A, Seat C. A Prospective Trial of Interrater and Intrarater Reliability of Wound Measurement Using a Smartphone App Versus the Traditional Ruler. Wounds.2017;29(9):E73-7. Available at: https://www.hmpgloballearningnetwork.com/site/wounds/rapid-communication/prospective-trial-interrater-and-intrarater-reliability-wound