Cohort demographic characteristics and comparison of participants who developed a new DFU during the study and those who did not
| . | All participants . | No DFU during study . | DFU during study . |
|---|---|---|---|
| Number of DFU | 53 | 0 | 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/m2) | 33.4 ± 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 participants . | No DFU during study . | DFU during study . |
|---|---|---|---|
| Number of DFU | 53 | 0 | 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/m2) | 33.4 ± 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.