Table 1

Intention-to-treat population characteristics (n=42)

CharacteristicChitoCare arm
N=18
Placebo arm
N=24
P value
Sex
N (%) female
6 (33.3)3 (12.5)0.212*
Age, years
Mean (SD), median (min-max)
59.2 (10.0), 58.7 (35.8–77.0)66.5 (9.3), 66.4 (45.9–84.9)0.016†
BMI, kg/m2
Mean (SD), median (min-max)
31.4 (4.1), 32.1 (22.5–39.7)30.7 (3.9), 30.6 (23.8–38.6)0.608†
Duration of diabetes at baseline, years
Mean (SD), median (min-max)
17.5 (12.6), 14 (1–54)20.6 (11.1), 25 (1–37)0.273†
eGFR, mL/min/1.73 m2
Mean (SD), median (min-max)
80.9 (28.5), 90.4 (31.4–113)‡70.4 (28.3), 76.6 (12.6–108)0.244†
HbA1c
%: Mean (SD), median (min-max) mmol/mol:
7.3 (1.1), 7.0 (5.6–9.7)
56 (12), 53 (38–83)
7.3 (1.3), 6.9 (5.5–10.2)
56 (14), 52 (37–88)
0.990†
Baseline wound area size, cm2
Mean (SD), median (min-max)
2.55 (1.87), 1.66 (0.50–5.80)2.01 (1.51), 1.33 (0.30–4.90)0.309†
Baseline Bates-Jensen score
Mean (SD), median (min-max)
27.9 (4.2), 28 (19–36)‡27.2 (3.1), 27 (21–34)‡0.536†
Wound duration, months
Mean (SD), median (min-max)
16 (28), 6.1 (1.3–109)‡22 (28), 5.6 (1.0–97)0.459†
  • 2 test.

  • †Mann-Whitney U test.

  • ‡Data missing for one patient within study arm (n=17 or n=23).

  • BMI, body mass index; eGFR, estimated glomerular filtration rate using CKD-EPI 2009 equation; HbA1c, hemoglobin A1c; max, maximum; min, minimum.