New Screening Tool to Prevent Mortality from Complications of Foot Ulcers

Risk factors associated with diabetic foot ulcers (DFU) are easily found in medical records, giving clinicians a tool for early detection.

Individuals with diabetes have around a 34% chance of developing a diabetic foot ulcer (DFU). This debilitating condition may lead to severe complications, including hospitalization, infection, and amputation. A recent study reported grim data on DFU, finding a five-year survival rate of just 29%. Any delay in treatment has been associated with worsened clinical outcomes. The researchers of this study were interested in identifying risk factors for DFU in patients with T2D. Early detection might one day reduce the number of diabetic foot ulcers.

The study included 980 patients who visited the diabetic clinic of Wuhan University People’s Hospital at least once and patients with a documented record of T2D. The study excluded individuals with diagnosed DFU on record. Researchers collected baseline characteristics from the medical records: including hospitalization, age, sex, BMI, educations, hypertension, hyperlipidemia, coronary heart disease, HF, stroke, diabetic retinopathy, diabetic kidney disease, diabetic neuropathy, A1C, and diabetes treatment. The primary clinical outcome was DFU. The statistical analysis of continuous variables was logged as mean +/- standard deviation (SD) or median and interquartile range. Continuous variables were compared with a Student t-test or the Kruskal-Wallis H test. Categorical variables were recorded as frequency and percentage. Comparisons were performed with the Chi-Squared test or Fisher’s Extract test. The incidence of DFU was calculated by dividing the total number of cases by the total observation time. The Univariable Cox regression analysis was used for factors associated with DFU. Average baseline characteristics included median follow-up time of 29 months, age 62 years, BMI 25, and an A1C of 7.9.

259 out of 980 individuals with T2D developed DFU, with the cumulative incidence being 2.2% at 6 months (95% CI 1.3-3.1%), 5.4% at 1-year (95% CI 3.9-6.9%) and 14.1% at 2-years (95% CI 11.7-16.5%). The Cox regression analysis found several factors associated with developing DFU: older age (hazard ratio (HR)=1.06, 95% CI 1.05-1.07, per 1-year increase), BMI (HR=1.05, 95% CI 1.02-1.07, per 1 kg/m2 increase), education level (HR 0.77, 95% CI 0.60-0.98), hypertension (HR 1.90, 95% CI 1.47-2.45), hyperlipidemia (HR 2.63, 95% CI 2.02-3.43), coronary heart disease (HR 2.88, 95% CI 2.22-3.75), heart failure (HR 2.47, 95% CI 1.91-3.20), stroke (HR 2.44, 95% CI 1.86-3.19), diabetic retinopathy (HR 1.86, 95% CI 1.40-2.48), diabetic kidney disease (HR 1.89, 95% CI 1.41-2.53), diabetic neuropathy (HR 1.73, 95% CI 1.31-2.30), poor glycemic control (HR 1.13, 95% CI 1.07-1.19, per 1% glycosylated hemoglobin increase), and course of diabetes (HR 1.01, 95% CI 1.00-1.01, per 1-month increase).

The study found that of the patients with T2D followed, over 25% later developed a diabetic foot ulcer. Several risk factors associated with DFU have been identified: including increased age, higher BMI, lower education, hypertension, hyperlipidemia, coronary heart disease, heart failure, stroke, diabetic retinopathy, diabetic neuropathy, diabetic kidney disease, poor glycemic control, and course of diabetes. A further study of these factors might help clinicians identify patients at risk for developing a diabetic foot ulcer. However, the study had several limitations, including a retrospective collection of data found in medical records. Additionally, follow-up of outcomes was based on hospitalization records. Therefore, some of the baseline characteristics identified might have fluctuated over time. Further studies are needed so that screening tools for DFU might one day be developed.

Practice Pearls:

• 259 out of 980 individuals with T2D developed DFU, with the cumulative incidence being 2.2% at six months, 5.4% at 1-year, and 14.1% at 2-years.
• The study identified several risk factors associated with DFU: including increased age, higher BMI, lower education, hypertension, hyperlipidemia, coronary heart disease, heart failure, stroke, diabetic retinopathy, diabetic kidney disease, diabetic neuropathy, poor glycemic control, and course of diabetes.
• Delayed treatment for diabetic foot ulcers has been associated with worsened clinical outcomes. Developing screening tools can significantly reduce complications associated with DFU.

Armstrong DG, Boulton AJM, and Bus SA. Dia­betic foot ulcers and their recurrence. N Engl J Med 2017; 376: 2367-2375.

Ouyang, Wenjuan et al. “Risk factors of diabetic foot ulcer in patients with type 2 diabetes: a retrospective cohort study.” American journal of translational research Aug. 2021.

Kornelia Ilias, Pharm.D. Candidate, Creighton University School of Pharmacy and Health Professions