Table 1. Baseline Patient Characteristics and Intervention During the Study.
| Characteristic | Patient groupa | ||
|---|---|---|---|
| ON101 (n = 122) | Absorbent dressing (n = 114) | All (N = 236) | |
| Baseline patient characteristics | |||
| Age, mean (SD), y | 57.4 (10.6) | 56.6 (11.3) | 57.0 (10.9) |
| Sex | |||
| Male | 93 (76.2) | 82 (71.9) | 175 (74.2) |
| Female | 29 (23.8) | 32 (28.1) | 61 (25.8) |
| Type 2 diabetes | 121 (99.2) | 113 (99.1) | 234 (99.2) |
| Diabetes duration, y | |||
| ≤10 | 55 (45.1) | 37 (32.5) | 92 (39.0) |
| >10 | 67 (54.9) | 77 (67.5) | 144 (61.0) |
| HbA1c level, % | |||
| Mean (SD) | 8.1 (1.5) | 8.1 (1.8) | 8.1 (1.6) |
| <9 | 90 (73.8) | 82 (71.9) | 172 (72.9) |
| ≥9 | 32 (26.2) | 32 (28.1) | 64 (27.1) |
| BMI | |||
| <25 | 59 (48.4) | 50 (43.9) | 109 (46.2) |
| ≥25 | 63 (51.6) | 64 (56.1) | 127 (53.8) |
| Hypertension | 78 (63.9) | 73 (64.0) | 151 (64.0) |
| CVD historyb | 25 (20.5) | 23 (20.2) | 48 (20.3) |
| Kidney status | |||
| eGFR, mL/min/1.73 m2 | |||
| ≥60 | 90 (73.8) | 81 (71.1) | 171 (72.5) |
| <60 | 32 (26.2) | 33 (28.9) | 65 (27.5) |
| ABI, mean (SD) | 1.1 (0.2) | 1.1 (0.1) | 1.11 (0.1) |
| Amputation historyc | 56 (45.9) | 60 (52.6) | 116 (49.2) |
| Wound conditions, Wagner grade | |||
| 1 | 29 (23.8) | 23 (20.2) | 52 (22.0) |
| 2 | 93 (76.2) | 91 (79.8) | 184 (78.0) |
| Ulcer size, cm2 | |||
| Mean (SD) | 5.0 (4.4) | 5.1 (4.7) | 4.8 (4.4) |
| 1-5 | 88 (72.1) | 77 (67.5) | 165 (69.9) |
| >5 | 33 (27.0) | 36 (31.6) | 69 (29.2) |
| Ulcer duration, mo | |||
| Mean (SD) | 7.2 (13.0) | 7.3 (13.9) | 7.15 (13.4) |
| <6 | 86 (70.5) | 79 (69.3) | 165 (69.9) |
| ≥6 | 36 (29.5) | 35 (30.7) | 71 (30.1) |
| Plantar ulcers | 64 (52.5) | 53 (46.5) | 117 (49.6) |
| Intervention during the study | |||
| Off-loading in plantar ulcerd | |||
| Use | 33 (51.6) | 34 (64.2) | 67 (57.3) |
| No use | 15 (23.4) | 9 (17.0) | 24 (20.5) |
| Not specified | 16 (25.0) | 10 (18.9) | 26 (22.2) |
| Diabetes medication prescribed | |||
| Metformin | 62 (50.8) | 51 (44.7) | 113 (47.9) |
| Insulin | 67 (54.9) | 67 (58.8) | 134 (56.8) |
| Any oral hypoglycemic agent | 84 (68.9) | 81 (71.1) | 165 (69.9) |
| Use of antibiotics | 30 (24.6) | 26 (22.8) | 56 (23.7) |
Abbreviations: ABI, ankle-brachial index; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CVD, cardiovascular disease; eGFR, estimated glomerular filtration rate; HbA1c, glycated hemoglobin.
SI conversion factor: To convert HbA1c to proportion of total hemoglobin, multiply by 0.01.
Unless otherwise indicated, data are expressed as number (%) of patients. Owing to missing data, numbers may not total column headings or percentages may not total 100. Absorbent dressing was Hydrofiber (ConvaTec Ltd).
Includes ischemic heart disease, coronary artery disease, or cerebral vascular accident with embolic, ischemic, or hemorrhagic stroke.
Due to previous diabetic foot ulcers.
Includes only patients with plantar ulcer.