Table 1

Cohort demographic characteristics and comparison of participants who developed a new DFU during the study and those who did not

All participantsNo DFU during studyDFU during study
Number of DFU53053
Number of participants1299237
Age (years)61.8 ± 10.562.2 ± 11.061.0 ± 9.3
Male86.0% (111/129)87.0% (80/92)83.8% (31/37)
Height (m)1.78 ± 0.11.77 ± 0.111.79 ± 0.08
Weight (kg)105.9 ± 23.7103.1 ± 23.9111.7 ± 22.2
BMI (kg/m2)33.4 ± 6.632.7 ± 6.934.8 ± 5.9
History of smoking42.6% (52/122)44.2% (38/86)38.9% (14/36)
History of alcohol use41.9% (39/93)42.6% (29/68)40.0% (10/25)
Performs regular exercise35.2% (45/128)35.2% (32/91)35.1% (13/37)
Living conditions
 Alone35.9% (46/128)38.0% (35/92)30.6% (11/36)
 With others64.1% (82/128)62.0% (57/92)69.4% (25/36)
Ambulatory status
 Active without assistance79.1% (102/129)78.3% (72/92)81.1% (30/37)
 Active with assistance17.8% (23/129)17.4% (16/92)18.9% (7/37)
 Inactive3.1% (4/129)4.3% (4/92)0.0% (0/37)
Years since diabetes diagnosed17.6 ± 10.816.9 ± 10.919.1 ± 10.7
Insulin-dependent60.5% (78/129)55.4% (51/92)73.0% (27/37)
Hemoglobin A1c
 DCCT-derived (%)8.3 ± 2.08.2 ± 2.18.6 ± 1.8
 IFCC-recommended (mmol/mol)67 ± 2266 ± 2370 ± 20
History of amputation55.7% (59/106)55.3% (42/76)56.7% (17/30)
History of Charcot arthropathy6.6% (8/122)5.7% (5/87)8.6% (3/35)
Months since last DFU healed13.9 ± 39.216.1 ± 45.18.2 ± 14.4
DFU history
 History of hallux DFU34.9% (45/129)31.5% (29/92)43.2% (16/37)
 History of minor toe DFU55.8% (72/129)52.2% (48/92)64.9% (24/37)
 History of metatarsal DFU41.9% (54/129)40.2% (37/92)45.9% (17/37)
 History of midfoot or heel DFU4.7% (6/129)3.3% (3/92)8.1% (3/37)
Vascular status
 Left ankle-brachial index1.14 ± 0.181.14 ± 0.161.17 ± 0.21
 Right ankle-brachial index1.18 ± 0.281.20 ± 0.311.15 ± 0.19
 Peripheral vascular disease9.9% (12/121)11.5% (10/87)5.9% (2/34)
 History of vascular surgery15.6% (20/128)15.4% (14/91)16.2% (6/37)
Neurological status
 Detects left 10-g monofilament17.9% (21/117)19.8% (16/81)13.9% (5/36)
 Detects right 10-g monofilament17.2% (20/116)18.8% (15/80)13.9% (5/36)
Wears therapeutic shoes86.3% (107/124)86.5% (77/89)85.7% (30/35)
VHA participant45.0% (58/129)46.7% (43/92)40.5% (15/37)
Study adherence (uses/week)5.5 ± 1.25.4 ± 1.35.6 ± 1.1
Temperature asymmetry (°C)**3.10 ± 1.572.81 ± 1.423.94 ± 1.68
  • Data are means ± SD or percentage (n/N).

  • DCCT, Diabetes Control and Complications Trial; IFCC, International Federation of Clinical Chemistry; VHA, Veterans Health Administration.

  • **P < 0.01.