Safety and risk management in clinical trials for chronic wounds with tissue regenerative products

Sep 30, 2026

Uploaded by Fahsai

Tissue regenerative clinical trials require balancing efficient study conduct with rigorous patient safety, since investigators work where routine care and research overlap. Social determinants can shape medication adherence and may increase trial risks if not addressed. This single-center retrospective study evaluated patient safety in tissue regenerative product trials for chronic wounds at a safety-net hospital, analyzing 186 subjects to relate social determinants of health to adverse events. Results showed higher adverse-event prevalence with polypharmacy and comorbidities.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages16

Reading Time40 min

AccessFree to download

Abstract

Background

Objectives

Design

Methods

Results

Conclusion

Plain language summary

Why was this study done?

What did the researchers do?

What did they find?

What does this mean?

Keywords

Introduction

Safety and risk management in clinical trials for chronic wounds with tissue regenerative products Marina Alexandra Malikova, Connor Michael Roddy, Nolan Patrick Joyce and Katherine Nicole Cilley Abstract Background: In tissue regenerative trials, investigators operate in the intersection of routine clinical care and research. Often, clinical trials are the only option to introduce innovative treatments to disadvantaged populations in safety-net hospitals (SNHs) . It is necessary to maintain a balance between efficient study conduct and patient safety. Social determinants play a role in medication adherence in clinical trials and chronic disease management that may increase risks if not managed correctly. Objectives: We aimed to assess the safety of patients in tissue regenerative clinical trials while examining underlying causes to develop proactive risk mitigation strategies for high-risk patients. Design: A single-center, retrospective study was conducted for clinical trials with tissue regenerative products for chronic wounds at an SNH. Methods: Data obtained from 186 subjects were analyzed retrospectively for correlation between social determinants of health and adverse events by using Spearman correlation and Kruskal–Wallis tests. Results: Wound healing was achieved in 41.94% of patients who received investigational products. Overall, the diabetic foot ulcer group was noted to have a higher prevalence of serious adverse events (SAEs; 22.8% of enrolled subjects) and adverse events (78 .3% of enrolled subjects) as compared to the venous stasis ulcer group, with 12.4% of SAEs and 71.0% adverse events observed in the study population. Kruskal–Wallis test demonstrated statistically significant correlation between polypharmacy ( ⩾5 drugs) and a higher number of adverse events (p = 0 . 0016) . A Spearman correlation test showed that a higher number ofcomorbidities was associated with a higher number of adverse events (p = 0 . 0007) . Conclusion: These findings in polypharmacy and comorbidities being associated with a higher number of adverse events highlighted the importance of safety monitoring of patients with high disease burden in clinical trials. Understanding the frequency/types of adverse events can provide important insights for those conducting trials in a particular indication. In addition, monitoring can help to address social determinants that contribute to higher numbers of adverse events, and proactively address disease burden with appropriate medical management to minimize risks in tissue regenerative clinical trials. Plain language summary Risk and safety management in wound healing Why was this study done? People with chronic wounds, like diabetic foot ulcers and venous ulcers, often don’t have access to new treatments unless they join clinical trials, especially at hospitals that serve low-income populations. It’s important to make sure TherAdv Drug Saf 2026, Vol. 17: 1–16 DOI: 10. 1177/ 20420986251385861 © The Author(s), 2026. Article reuse guidelines: [sagepub.com/journals](sagepub.com/journals)permissions Correspondence to: Marina Alexandra Malikova Department of Surgery, Chobanian and Avedisian School of Medicine, Boston Medical Center, Boston University, 85 East Concord Street, Boston, MA 02118, USA Marina. Malikova@bmc. org; [mmalikov@bu.edu](mmalikov@bu.edu) Connor Michael Roddy Nolan Patrick Joyce Katherine Nicole Cilley Department of Surgery, Chobanian and Avedisian School of Medicine, Boston Medical Center, Boston University, Boston, MA, USA [journals.sagepub.com/home/taw](journals.sagepub.com/home/taw) 1 Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ([https://creativecommons.org/licenses/by-nc/4.0/](https://creativecommons.org/licenses/by-nc/4.0/)) which permits non-commercial use, reproduction and distribution of the work without further permission

FAQs

What was the primary goal of the study?

To assess patient safety in tissue regenerative clinical trials for chronic wounds while examining underlying causes to build proactive risk mitigation strategies for high-risk patients.

How were adverse events analyzed in relation to social determinants?

The study retrospectively analyzed data from 186 subjects and assessed correlations between social determinants of health and adverse events using Spearman correlation and Kruskal–Wallis tests.

Which patient factors were linked to more adverse events?

Polypharmacy (≥5 drugs) and a higher number of comorbidities were statistically associated with a greater number of adverse events, with diabetic foot ulcer patients showing a higher prevalence of serious adverse events and adverse events than venous ulcer patients.

Sep 30, 2026

Uploaded by Fahsai