Table 2.
Baseline characteristics of participants included vs not included in the 12‐month observational study
| Participant characteristics | Included in this study, N=299 | Not included in this study, N=101 |
|---|---|---|
| Mean (sd) agea, years | 64.3 (12.8) | 59.3 (14.2) |
| Sex: male, n (%) | 233 (77.9) | 83 (82.2) |
| Type of facility, n (%) | ||
| Hospital ward | 38 (12.7) | 15 (14.9) |
| Outpatient clinic | 241 (80.6) | 78 (77.2) |
| Community clinic | 20 (6.7) | 8 (7.9) |
| Diabetes type, n (%) | ||
| Type 1 | 40 (13.4) | 18 (17.8) |
| Type 2 | 259 (86.6) | 83 (82.2) |
| Mean (sd) diabetes duration, years | 17.2 (11.1) | 15.5 (10.5) |
| Mean (sd) HbA1c | ||
| mmol/mol | 70.6 (24.51) | 75.3 (26.20) |
| % | 8.61 (2.24) | 9.04 (2.40) |
| Current diabetes treatment, n (%) | ||
| Oral hypoglycaemic | 77 (26.6) | 30 (31.3) |
| Insulin | 126 (43.6) | 42 (43.8) |
| Both insulin and oral hypoglycaemic | 85 (29.4) | 24 (25.0) |
| Other | 1 (0.3) | 0 (0.0) |
| None | 10 (3.3) | 5 (5.0) |
| Foot with index ulcer, n (%) | ||
| Right foot | 150 (50.2) | 55 (54.5) |
| Number of ulcers on index foot, n (%) | ||
| Single ulcer | 222 (74.2) | 82 (81.2) |
| Multiple ulcers | 77 (25.8) | 19 (18.8) |
| Index ulcer location, n (%) | ||
| Apex (i.e. tip of toe) | 31 (10.4) | 16 (15.8) |
| Interdigital | 18 (6.0) | 7 (6.9) |
| Plantar | 133 (44.5) | 39 (38.6) |
| Dorsum | 38 (12.7) | 18 (17.8) |
| Digital | 70 (23.4) | 20 (19.8) |
| Other | 7 (2.3) | 1 (1.0) |
| Duration of index ulcer, months | ||
| Median (IQR)Range | 1.8 (0.7 to 6.0) (0.1 to 75.0) | 1.8 (0.7 to 4.6) (0.2 to 144.0) |
| Ulcer recurrenceb, n (%) | ||
| Incident (first) | 206 (68.9) | 82 (81.2) |
| Recurrent (repeat) | 91 (30.4) | 19 (18.8) |
| Ulcer type, n (%) | ||
| Ischaemic or neuro‐ischaemic | 142 (47.5) | 54 (53.5) |
| Neuropathic only | 155 (51.8) | 47 (46.5) |
| PEDIS classification, n (%) | ||
| Perfusion | ||
| Grade 1: no symptoms/signs of PAD | 147 (49.2) | 53 (52.5) |
| Grade 2: symptoms or signs of PAD, no critical limb ischaemia | 146 (48.8) | 46 (45.5) |
| Grade 3: critical limb ischaemia | 6 (2.0) | 2 (2.0) |
| Depth/tissue loss | ||
| Grade 1: superficial full‐thickness ulcer not penetrating structures deeper than the dermis | 96 (32.1) | 35 (34.7) |
| Grade 2: ulcer penetrating below dermis to subcutaneous structures | 100 (33.4) | 34 (33.7) |
| Grade 3: all subsequent layers of foot, including bone/joint | 103 (34.4) | 32 (31.7) |
| Infection | ||
| Grade 1: no symptoms/signs of inflammation | 0 (0.0) | 2 (2.0) |
| Grade 2: inflammation of skin/subcutaneous tissue only | 104 (34.8) | 45 (44.6) |
| Grade 3: extensive erythema deeper than skin/subcutaneous tissue | 185 (61.9) | 52 (51.5) |
| Grade 4: systemic inflammatory response syndrome | 10 (3.3) | 2 (2.0) |
| Sensation | ||
| Grade 1: no loss of protective sensation | 20 (6.7) | 7 (6.9) |
| Grade 2: loss of protective sensation | 279 (93.3) | 94 (93.1) |
| Wagner classification, n (%) | ||
| Grade 1: superficial diabetic ulcer | 104 (34.8) | 32 (31.7%) |
| Grade 2: ulcer extension ligament, tendon, joint capsule or deep fascia without abscess or osteomyelitis | 93 (31.1) | 41 (40.6) |
| Grade 3: deep ulcer with abscess, osteomyelitis or joint sepsis | 96 (32.1) | 26 (25.7) |
| Grade 4: gangrene localized to portion of forefoot or heel | 5 (1.7) | 2 (2.0) |
| Grade 5: extensive gangrenous involvement of the entire foot | 1 (0.3) | 0 (0.0) |
| Antimicrobial dressing on ulcer, n (%) | 175 (58.5) | 66 (65.3) |
| Currently on antibiotic therapy, n (%) | 139 (46.5) | 48 (47.5) |
| Pathogens reported, n (%) | 263 (88.0) | 90 (89.1) |
PAD, peripheral arterial disease.
a
t‐test for difference in age between groups P=0.001.
b
Chi‐squared test for association between ulcer recurrence and group P=0.0217
Chi‐squared test for association between infection grades (Grade 1/2 vs 3/4) and group P=0.0352.