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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 DFU 53 53 
Number of participants 129 92 37 
Age (years) 61.8 ± 10.5 62.2 ± 11.0 61.0 ± 9.3 
Male 86.0% (111/129) 87.0% (80/92) 83.8% (31/37) 
Height (m) 1.78 ± 0.1 1.77 ± 0.11 1.79 ± 0.08 
Weight (kg) 105.9 ± 23.7 103.1 ± 23.9 111.7 ± 22.2 
BMI (kg/m233.4 ± 6.6 32.7 ± 6.9 34.8 ± 5.9 
History of smoking 42.6% (52/122) 44.2% (38/86) 38.9% (14/36) 
History of alcohol use 41.9% (39/93) 42.6% (29/68) 40.0% (10/25) 
Performs regular exercise 35.2% (45/128) 35.2% (32/91) 35.1% (13/37) 
Living conditions    
 Alone 35.9% (46/128) 38.0% (35/92) 30.6% (11/36) 
 With others 64.1% (82/128) 62.0% (57/92) 69.4% (25/36) 
Ambulatory status    
 Active without assistance 79.1% (102/129) 78.3% (72/92) 81.1% (30/37) 
 Active with assistance 17.8% (23/129) 17.4% (16/92) 18.9% (7/37) 
 Inactive 3.1% (4/129) 4.3% (4/92) 0.0% (0/37) 
Years since diabetes diagnosed 17.6 ± 10.8 16.9 ± 10.9 19.1 ± 10.7 
Insulin-dependent 60.5% (78/129) 55.4% (51/92) 73.0% (27/37) 
Hemoglobin A1c    
 DCCT-derived (%) 8.3 ± 2.0 8.2 ± 2.1 8.6 ± 1.8 
 IFCC-recommended (mmol/mol) 67 ± 22 66 ± 23 70 ± 20 
History of amputation 55.7% (59/106) 55.3% (42/76) 56.7% (17/30) 
History of Charcot arthropathy 6.6% (8/122) 5.7% (5/87) 8.6% (3/35) 
Months since last DFU healed 13.9 ± 39.2 16.1 ± 45.1 8.2 ± 14.4 
DFU history    
 History of hallux DFU 34.9% (45/129) 31.5% (29/92) 43.2% (16/37) 
 History of minor toe DFU 55.8% (72/129) 52.2% (48/92) 64.9% (24/37) 
 History of metatarsal DFU 41.9% (54/129) 40.2% (37/92) 45.9% (17/37) 
 History of midfoot or heel DFU 4.7% (6/129) 3.3% (3/92) 8.1% (3/37) 
Vascular status    
 Left ankle-brachial index 1.14 ± 0.18 1.14 ± 0.16 1.17 ± 0.21 
 Right ankle-brachial index 1.18 ± 0.28 1.20 ± 0.31 1.15 ± 0.19 
 Peripheral vascular disease 9.9% (12/121) 11.5% (10/87) 5.9% (2/34) 
 History of vascular surgery 15.6% (20/128) 15.4% (14/91) 16.2% (6/37) 
Neurological status    
 Detects left 10-g monofilament 17.9% (21/117) 19.8% (16/81) 13.9% (5/36) 
 Detects right 10-g monofilament 17.2% (20/116) 18.8% (15/80) 13.9% (5/36) 
Wears therapeutic shoes 86.3% (107/124) 86.5% (77/89) 85.7% (30/35) 
VHA participant 45.0% (58/129) 46.7% (43/92) 40.5% (15/37) 
Study adherence (uses/week) 5.5 ± 1.2 5.4 ± 1.3 5.6 ± 1.1 
Temperature asymmetry (°C)** 3.10 ± 1.57 2.81 ± 1.42 3.94 ± 1.68 
All participantsNo DFU during studyDFU during study
Number of DFU 53 53 
Number of participants 129 92 37 
Age (years) 61.8 ± 10.5 62.2 ± 11.0 61.0 ± 9.3 
Male 86.0% (111/129) 87.0% (80/92) 83.8% (31/37) 
Height (m) 1.78 ± 0.1 1.77 ± 0.11 1.79 ± 0.08 
Weight (kg) 105.9 ± 23.7 103.1 ± 23.9 111.7 ± 22.2 
BMI (kg/m233.4 ± 6.6 32.7 ± 6.9 34.8 ± 5.9 
History of smoking 42.6% (52/122) 44.2% (38/86) 38.9% (14/36) 
History of alcohol use 41.9% (39/93) 42.6% (29/68) 40.0% (10/25) 
Performs regular exercise 35.2% (45/128) 35.2% (32/91) 35.1% (13/37) 
Living conditions    
 Alone 35.9% (46/128) 38.0% (35/92) 30.6% (11/36) 
 With others 64.1% (82/128) 62.0% (57/92) 69.4% (25/36) 
Ambulatory status    
 Active without assistance 79.1% (102/129) 78.3% (72/92) 81.1% (30/37) 
 Active with assistance 17.8% (23/129) 17.4% (16/92) 18.9% (7/37) 
 Inactive 3.1% (4/129) 4.3% (4/92) 0.0% (0/37) 
Years since diabetes diagnosed 17.6 ± 10.8 16.9 ± 10.9 19.1 ± 10.7 
Insulin-dependent 60.5% (78/129) 55.4% (51/92) 73.0% (27/37) 
Hemoglobin A1c    
 DCCT-derived (%) 8.3 ± 2.0 8.2 ± 2.1 8.6 ± 1.8 
 IFCC-recommended (mmol/mol) 67 ± 22 66 ± 23 70 ± 20 
History of amputation 55.7% (59/106) 55.3% (42/76) 56.7% (17/30) 
History of Charcot arthropathy 6.6% (8/122) 5.7% (5/87) 8.6% (3/35) 
Months since last DFU healed 13.9 ± 39.2 16.1 ± 45.1 8.2 ± 14.4 
DFU history    
 History of hallux DFU 34.9% (45/129) 31.5% (29/92) 43.2% (16/37) 
 History of minor toe DFU 55.8% (72/129) 52.2% (48/92) 64.9% (24/37) 
 History of metatarsal DFU 41.9% (54/129) 40.2% (37/92) 45.9% (17/37) 
 History of midfoot or heel DFU 4.7% (6/129) 3.3% (3/92) 8.1% (3/37) 
Vascular status    
 Left ankle-brachial index 1.14 ± 0.18 1.14 ± 0.16 1.17 ± 0.21 
 Right ankle-brachial index 1.18 ± 0.28 1.20 ± 0.31 1.15 ± 0.19 
 Peripheral vascular disease 9.9% (12/121) 11.5% (10/87) 5.9% (2/34) 
 History of vascular surgery 15.6% (20/128) 15.4% (14/91) 16.2% (6/37) 
Neurological status    
 Detects left 10-g monofilament 17.9% (21/117) 19.8% (16/81) 13.9% (5/36) 
 Detects right 10-g monofilament 17.2% (20/116) 18.8% (15/80) 13.9% (5/36) 
Wears therapeutic shoes 86.3% (107/124) 86.5% (77/89) 85.7% (30/35) 
VHA participant 45.0% (58/129) 46.7% (43/92) 40.5% (15/37) 
Study adherence (uses/week) 5.5 ± 1.2 5.4 ± 1.3 5.6 ± 1.1 
Temperature asymmetry (°C)** 3.10 ± 1.57 2.81 ± 1.42 3.94 ± 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.

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