Reporting of Social Demographics in Diabetic Foot Ulcer Randomized Controlled Trials: A Scoping Review
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Abstract
Background. Diabetic foot ulcerations (DFUs) remain a major public health issue, disproportionately affecting diverse populations. The extent to which race, ethnicity, and social demographics are reported in randomized controlled trials (RCTs) on graft treatments for DFU remains unclear. Objective. To assess the reporting frequency of these patient characteristics and social determinants of health in order to provide insight into providing more representative, evidence-based care. Methods. Following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, a scoping review of PubMed was conducted for RCTs on graft treatment for DFU published in the years 2014 to 2024. Studies were screened for the reporting and analysis of demographics, including age, sex, race, ethnicity, and social determinants of health. Results. Among 63 studies, 100% reported age, 98% reported sex, and 67% reported weight or body mass index. Race and ethnicity were reported in 46% and 27% of studies, respectively. Insurance and socioeconomic class were noted in 2% and 3% of studies, respectively, with no income data reported. Bivariate or multivariate analyses of these variables in relation to outcomes were performed for age (10%), sex (13%), race (11%), and ethnicity (8%). Conclusion. Reporting of race, ethnicity, and social determinants of health in RCTs on grafting for DFU is limited. Given the effect of these factors on outcomes, future studies should prioritize them to improve research representation and patient care.
Affecting just over one-third of persons with diabetes during their lifetime, diabetic foot ulcers (DFUs) remain a frequently encountered pathology with life-altering consequences.1 With approximately half of such ulcerations resulting in infection, and 20% of those modereate to severe infections leading to some type of amputation, appreciating both determinants that are inherent to the infectious process and determinants that are extrinsic to it remains imperative to treatment.2 Whether bioengineered skin substitutes or other means of skin replacement, adjuvants to traditional wound care used in an effort to heal such ulcerations have been extensively studied.3,4 However, with previous investigations showing that racial and ethnic minority groups are more likely to develop diabetes and subsequent ulcerations and amputations compared with White individuals, understanding the role of similar social determinants of health provides an important framework when treating these DFUs.5
Across surgical specialties, race has been shown to play a role in surgical outcomes. For example, Black patients had an increased rate of postoperative complications and mortality following hip and knee arthroplasty when compared with White patients.6 There has been infrequent reporting and analysis of race and ethnicity across orthopedic surgery and its subspecialties.7 Although underrepresentation and disparate outcomes related to race and ethnicity have been documented in other surgical specialties, similar analyses remain limited in orthopedics, which continues to raise concern among clinicians, researchers, and health-equity stakeholders. Enrolling and reporting findings representative of the population that treatment modalities are intended to treat remains challenging.8 While there is no paucity of data concerning randomized controlled trials (RCTs) on DFU treatment, little is known about the population from which these investigations pool their samples, if this is reported at all.
To the knowledge of the authors of the present study, no prior studies have specifically analyzed the reporting of race, ethnicity, and other demographics within RCTs investigating graft-based treatments for DFUs. The primary aim of the present study is to describe the proportion of these RCTs that report race, ethnicity, and other basic patient demographics. Secondary aims of this study are to record the frequency with which social determinants of health are reported. Results of this investigation will shed light on patient characteristics that are being reported in the highest-level studies and will drive an evidence-based approach to care. These findings will support clinicians and researchers in considering the representative population studied in these RCTs as compared with the patients they encounter in various practice types and locations.
Methods
A scoping review using Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines was performed, as illustrated in Figure 1, using methodology that closely followed that of a previous investigation.7 The following terms were searched on PubMed, with filters specific for RCTs for the years 2014 to 2024: diabetic foot ulcer and advanced wound care dressing, biological wound cover, regenerative skin matrix, bioengineered skin graft, dermal substitute, wound matrix, cellular tissue product, synthetic skin substitute, allograft, xenograft, collagen wound matrix, epidermal replacement, bioactive wound care product, and acellular dermal matrix.
Following identification and screening for studies that met final inclusion criteria, articles were assessed for the presence of age, sex, height, weight, race, ethnicity, insurance coverage, socioeconomic class, and income. Sex was defined as the biological classification of male or female as reported in the articles. Race was defined as a socially constructed categorization based on physical characteristics, and ethnicity was defined as cultural identification, language, or heritage. In studies that used these terms interchangeably, they were recorded according to the terminology provided in the original study. Although not explicitly labeled as such, insurance coverage, socioeconomic class, and income were treated as proxies for social determinants of health, which were defined as societal systems and their components that control the distribution of resources and hazards, shaping health outcomes and demographic patterns.9
Reporting of these variables included simply publishing that such variables were recorded. Reporting of analysis of these variables was also assessed in relation to the outcome of interest. Any statistical testing beyond basic between-group demographic comparisons, including analyses of variables outside of demographics or bivariate or multivariate analyses within this group, was assessed. Results were reported in the form of counts and frequencies. Data was recorded and analyzed using Microsoft Excel (Redmond, Washington).
Results
After applying the selection criteria, a total of 63 studies were analyzed, with various demographic and socioeconomic characteristics mentioned across the studies, as reported in Figure 2.10-73 Age was reported in all studies (100%), and sex was noted in 98%. Weight or body mass index (BMI) was reported in 67% of the studies, indicating moderate coverage of body composition–related metrics. Race was mentioned in 46% of the studies, and ethnicity was noted in 27%. In contrast, only 2% of articles included data concerning insurance coverage, making it one of the least mentioned variables. The proportion of studies that included bivariate or multivariable analyses of these respective demographic measurements were 10% for age, 13% for sex, 11% for race, and 8% for ethnicity as shown in Figure 3.
Discussion
Defined as the societal systems and resources that influence health by distributing, allocating, or withholding benefits and risks, leading to changes in health outcomes across different demographic groups, social determinants of health play an important role in patient care.9 Socioeconomic disadvantages have been found to contribute to an increased burden of mortality in patients with diabetes who develop foot ulceration.73 Similarly, determinants such as residential address have been associated with infection of DFU.74 While biologic and other adjuvant therapies aim to accelerate the healing process of DFUs, acknowledging the influence of social determinants of health is important when interpreting the efficacy of these adjuvant therapies. This scoping review analyzes both the reporting and the analysis of such variables as they pertain to RCTs on DFU treatment.
The results of the present investigation show that whereas the majority of RCTs reported the typical demographic data such as age, sex, and weight or BMI, less than half reported race or ethnicity. Moreover, there was little to no mention of insurance coverage, socioeconomic status, or income. This infrequency in reporting similar variables has been reported in orthopedic literature.7,75 Along with the minimal reporting of these social determinants of health, there is even less analysis of these determinants as they relate to the outcomes of interest. While baseline comparison between control and experimental groups remains standard so as to ensure cohorts remain comparable, this does not entirely reflect the influence of social determinants on outcomes. Notably, in wound care as a whole, it has been found that the patient’s environment, urban or rural, is responsible for up to 50% variation in wound healing.76 Although there is debate regarding whether collection of such data is required for institutional review board approval, it remains important to include these assessment points with consideration for the population being surveyed. For example, previous studies have indicated differences in willingness to participate among racial and ethnic groups, often depending on the nature of the study.77 Hesitancy may stem from historical abuses, for example the Tuskegee Syphilis Study or prior unethical medical experimentation, as well as from language barriers, for example lack of translated materials or limited access to bilingual research staff; future protocols should account for these challenges.77-79
To improve the representativeness and external validity of future wound care RCTs, a broader range of social determinants of health should be systematically collected. Although not examined in the present investigation due to limited reporting among existing RCTs, variables such as education level, employment status, and primary language are essential, because they influence health literacy, adherence to off-loading and dressing regimens, and the ability to engage in follow-up care.80-83 Additional determinants, including food security, transportation access, caregiver coordination, and housing stability, also play meaningful roles in wound healing and treatment adherence.84-86 Importantly, these factors are relevant not only to DFU but to wound care research more broadly because they affect access to care, capacity for self-management, and overall healing trajectories across diverse wound types. Incorporating these variables into study design and reporting will strengthen the applicability of RCT findings to real-world clinical populations.
Limitations
This scoping review has limitations. First, because only RCTs published from 2014 to 2024 were reviewed, there may be relevant or newer studies that were not captured. Second, the sole reliance on PubMed for the literature search may have excluded pertinent studies in other databases. Finally, the study does not assess the reasons for the underreporting of key demographics, nor does it evaluate the effect of this underreporting on clinical outcomes, both of which are areas that warrant further investigation. Despite these limitations, the outcomes shared in this study provide insight into the current deficiencies among RCTs on DFU.
Conclusion
The reporting of race, ethnicity, and social determinants of health in RCTs on graft treatment for DFU remains insufficient. Given the established link between diabetic complications and these factors, inclusion of these factors in future research is critical. Incorporating these variables from the outset, including in project proposals and in submission for institutional review board approval, will enhance the relevance of findings and lead to more representative evidence-based care. Future studies should prioritize comprehensive demographic reporting to improve clinical outcomes for diverse populations.
Improving reporting practices requires understanding why these gaps persist. Underreporting may reflect inconsistent institutional requirements, the perception that social factors are secondary, or recruitment barriers such as mistrust and language differences. Furthermore, limited demographic transparency may reduce the external validity of DFU RCTs and risks perpetuating inequities in care. Without adequate representation, trial findings may not capture the populations most affected by diabetic complications. Standardized expectations for reporting demographic and social determinants of health are needed to strengthen scientific rigor and ensure that advances benefit diverse patient groups equitably.
Author and Public Information
Authors: Dominick J. Casciato, DPM1; Kevin Ruiz, MS-42; Nigel Morris, DPM1; and Joshua Calhoun, DPM1
Affiliations: 1Orlando VA Medical Center, Orlando, FL, USA; 2University of Central Florida College of Medicine, Orlando, FL, USA
Acknowledgments: The authors would like to acknowledge Stephen L. Smith, PhD, senior medical writer at Medline Industries, LP, for providing medical writing support in the preparation of this manuscript. The authors would also like to acknowledge Grace Furman, BS, associate biostatistician at Medline Industries, LP, for providing data analysis.
This material is the result of work supported with resources and the use of facilities at the the Orlando VA Healthcare System.
Disclosure: No financial disclosures or conflicts of interest are reported by the authors. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the United States government.
Correspondence: Dominick J. Casciato, DPM; Orlando VA Medical Center, 13800 Veterans Way, Orlando, FL 32827; dominickcasciatodpm@gmail.com.
Manuscript Accepted: November 13, 2025
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