Study: Standardized Clinical Foot Examination in Diabetic Hemodialysis Patients

In individuals with diabetes mellitus (DM), atherosclerosis and neuropathy contribute to an increased risk of peripheral vascular disease (PVD) and adverse outcomes, including ulcers, infections, limb amputation, hospitalizations and mortality. The same risk applies to patients on hemodialysis (HD) caused by uremic neuropathy, arteria media sclerosis and other microvascular problems. In fact, HD has been identified as an independent risk factor for foot ulcers. Because reductions in pain and other symptoms from neuropathy often result in late diagnosis, both the American College of Cardiology/American Heart Association (ACC/AHA) and the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines recommend screening individuals at risk.

With this increased risk for potentially serious complications in mind, DaVita International analyzed the frequency of foot complications following implementation of a standardized foot examination in 345 patients with DM and on hemodialysis in 12 centers in Poland and Portugal. Hospitalizations and cause-specific mortality were documented during 44 months of follow up.

The protocol for examinations included taking a history of the patient (ulcers, amputation), inspecting the feet (skin, nails) and checking the pedal pulses (dorsalis pedis and posterior tibial arteries). Foot complications were classified according to Wagner grading score (ranging from grade 0 to 5, with grade 0 being no break in skin and grade 5, midfoot or hindfoot gangrene) and PVD was classified by clinical pulse measurement (normal vs. weak or missing). Risks for hospitalization and mortality were analyzed using Cox proportional hazard models.

Patients were 58% men and on average 70.4 years old (standard deviation, 14 years). A normal pulse in left and right a dorsalis pedis and in left and right posterior tibial arteries was found in 17% and 10%, respectively. All other patients had weak or absent pulses. The Wagner classification score was 0 or 1 in 88% of patients, 2-3 in 6%, and 4-5 in 5%.

After the 44-month follow-up, the following results were observed:

• All-cause mortality was 31% and 71% of patients had at least one hospital stay.
  • Cardio-cerebrovascular, PVD, and infection accounted for 76% of all mortality.
• In unadjusted analyses, presence of weak or absent pulses in a dorsalis pedis arteries were significantly associated with all-cause mortality; the relative risk (RR) was 2.1 (Confidence interval [CI]: 1.1 to 4.3; p-value [p] < 0.05).
• In adjusted models including age, sex, hemoglobin, albumin, dialysis adequacy (Kt/V), vascular access, phosphorus, parathyroid hormone (PTH) and Charlson Comorbidity Index, only albumin was associated with mortality (RR: 0.89, CI: 0.84-0.94; p < 0.001) and risk of hospitalization (RR: 0.92, CI: 0.89-0.96; p < 0.001).

In conclusion, implementation of a standardized foot examination protocol in HD patients with DM showed a high prevalence of clinically significant complications that warrant close attention. This foot examination is a suitable clinical tool to identify patients at high risk of future complications and could be the basis of a program to improve overall health outcomes.

For more information, read the research poster (which was presented at ASN), here.