Table 3 Baseline participant characteristics
Baseline participant characteristics | All participants | Confirmed diagnosis of Charcot | ||
|---|---|---|---|---|
All randomised participants [n = 43] | Confirmed diagnosis Charcot [n = 30] | Standard care plus (n = 16) | Intervention (n = 14) | |
Sociodemographic | ||||
 Men n [%] | 29 [67%] | 20 [67%] | 12 [75%] | 8 [57%] |
 Age (yrs) mean ± SD | 59.1 ± 11.2 | 59.2 ± 10.8 | 59.2 ± 9.4 | 51.5 ± 10.8 |
Highest education n [%] | n = 37 | n = 27 | n = 13 | n = 14 |
 Left school before 16 | 4 [11%] | 2 [7%] | 1 [8%] | 1 [7%] |
 Stayed in school until 16 | 11 [30%] | 8 [30%] | 4 [31%] | 4 [29%] |
 Stayed in education until 18 | 6 [16%] | 4 [15%] | 3 [23%] | 1 [7%] |
 Vocational/occupational qualification | 8 [22%] | 7 [30%] | 2 [15%] | 5 [36%] |
 Degree | 6 [16%] | 4 [15%] | 2 [15%] | 2 [14%] |
 Masters | 1 [3%] | 1 [4%] | 1 [8%] | 0 |
 Doctorate | 1 [3%] | 1 [4%] | 0 | 1 [7%] |
Diabetes and diabetes related complications | ||||
 Type 2 diabetes n [%] | 34 [79%] | 22 [73%] | 12 [75%] | 10 [71%] |
 Duration of diabetes (yrs) mean ± SD | 19 ± 11.2 | 20.5 ± 11.3 | 24.6 ± 13 | 15.8 ± 6.7 |
 HbA1c mmol/mol median [25th–75th IQR] | 69 IQR 57–87 | 77.5 IQR 60–96 | 73.5 IQR 61–84 | 77.5 IQR 59–99 |
eGFR < 60 n [%] | 13 [30%] | 9 [30%] | 3 [19%] | 6 [43%] |
 Type 1 BMI mean ± SD | 30.9 ± 6.3 | 32.1 ± 5.4 | 33.8 ± 5.9 | 30.6 ± 5.1 |
 Type 2 BMI mean ± SD | 32.5 ± 7.0 | 32.1 ± 6.5 | 32.2 ± 7.7 | 32.2 ± 5.2 |
 Cerebrovascular events n [%] | 4 [9%] | 2 [7%] | 1 [6%] | 1 [7%] |
 Cardiovascular events n [%] | 10 [23%] | 6 [20%] | 2 [13%] | 4 [29%] |
 Nephropathy n [%] | 11 [26%] | 9 [30%] | 2 [13%] | 7 [50%] |
 Retinopathy n [%] | 18 [42%] | 14 [47%] | 10 [63%] | 4 [29%] |
Palpation foot pulses n [%] | ||||
 No foot pulses palpable | 4 [9%] | 3 [10%] | 1 [6%] | 2 [14%] |
 One-foot pulse palpable | 1 [2%] | 0 | 0 | 0 |
 Two-foot pulses palpable | 38 [88%] | 27 [90%] | 15 [94%] | 12 [86%] |
Ankle Brachial Index n [%] | n = 41 | n = 28 | n = 15 | n = 12 |
 Ankle Brachial Index 0.5–0.79 | 1 [2%] | 1 [4%] | 1 [4%] | 0 |
 Ankle Brachial Index 0.8–0.99 | 4 [10%] | 3 [11%] | 0 | 3 [25%] |
 Ankle Brachial Index 1.0–1.4 | 31 [76%] | 22 [79%] | 13 [81%] | 9 [75%] |
 Ankle Brachial Index > 1.4 | 5 [12%] | 2 [7%] | 2 [13%] | 0 |
Monofilament perception n [%] | ||||
 -ve at 3/3 sites | 33 [77%] | 24 [80%] | 13 [81%] | 11 [79%] |
 -ve at 2/3 sites | 4 [9%] | 0 | 0 | 0 |
 -ve at 1/3 sites | 1 [2%] | 2 [7%] | 1 [6%] | 1 [7%] |
 +ve at all sites n [%] | 5 [12%] | 4 [13%] | 2 [13%] | 2 [14%] |
Mean vibration perception at hallux | n = 29 | n = 22 | n = 11 | n = 11 |
 Hallux (≥25 V) | 23 [79%] | 19 [86%] | 10 [91%] | 9 [82%] |
Previous or current foot complications n [%] | ||||
 Previous minor amputation index foot | 7 [16%] | 5 [17%] | 4 [25%] | 1 [7%] |
 Previous minor amputation contralateral foot | 5 [12%] | 4 [13%] | 3 [19%] | 1 [7%] |
 History of previous Charcot either foot | 6 [14%] | 6 [20%] | 3 [19%] | 3 [21%] |
 Ulceration at enrolment on index foot | 12 [30%] | 7 [23%] | 5 [31%] | 2 [14%] |
 Ulceration at enrolment on contralateral foot | 1 [2%] | 0 | 0 | 0 |