Study outcomes
| Outcome parameter | Enhanced therapy | Usual care | Relative risk (95% CI) | P value |
| Number of participants | 151 | 153 | ||
| Ulcer recurrence at primary site | ||||
| Participants with ulcer | 44 (29.1%) | 57 (37.3%) | 0.782 (0.566 to 1.080) | 0.133 |
| Ulcer site | 0.316 | |||
| Hallux plantar/apex | 9 (20.5%) | 10 (17.5%) | ||
| Toes plantar/apex | 7 (15.9%) | 4 (7.0%) | ||
| Interdigital spaces | 3 (6.8%) | 3 (5.3%) | ||
| Plantar metatarsal heads | 15 (34.1%) | 19 (33.3%) | ||
| Medial border first ray | 3 (6.8%) | 9 (15.8%) | ||
| Lateral border fifth ray | 4 (9.1%) | 6 (10.5%) | ||
| Midfoot plantar | 2 (4.5%) | 4 (7.0%) | ||
| Heel plantar | 1 (2.3%) | 2 (3.5%) | ||
| Reported cause of ulcer | 0.994 | |||
| Mechanical stress | 34 (77.3%) | 45 (78.9%) | ||
| Direct trauma | 3 (6.8%) | 4 (7.0%) | ||
| Ischemia | 1 (2.3%) | 1 (1.8%) | ||
| Unknown | 6 (13.6%) | 7 (12.3%) | ||
| Ulcer per center category | 0.005 | |||
| University Medical Center | 21 (50.0%) | 19 (41.3%) | 1.211 (0.765 to 1.195) | 0.413 |
| Community hospital | 13 (19.1%) | 30 (45.5%) | 0.421 (0.241 to 0.733) | 0.001 |
| Podiatry practice | 10 (24.4%) | 8 (19.5%) | 1.250 (0.549 to 2.846) | 0.594 |
| Ulcer per participating center | ||||
| Amsterdam UMC, location AMC | 15 (31.9%) | 14 (29.2%) | 1.094 (0.596 to 2.008) | 0.771 |
| Amsterdam UMC, location VUmc | 5 (55.6%) | 3 (33.3%) | 1.667 (0.559 to 4.973) | 0.343 |
| Maastricht UMC+ | 8 (66.7%) | 8 (61.5%) | 1.083 (0.602 to 1.949) | 0.79 |
| Ziekenhuisgroep Twente | 6 (26.1%) | 11 (42.3%) | 0.617 (0.271 to 1.402) | 0.234 |
| Reinier de Graaf Gasthuis | 6 (28.6%) | 8 (40.0%) | 0.714 (0.301 to 1.694) | 0.44 |
| Maxima Medisch Centrum | 2 (6.3%) | 13 (40.6%) | 0.154 (0.038 to 0.627) | 0.001 |
| Medisch Spectrum Twente | 2 (28.6%) | 0 (0.0%) | 0.714 (0.447 to 1.141) | 0.19 |
| Complicated ulcer* | 11 (25.0%) | 19 (33.3%) | 0.750 (0.400 to 1.408) | 0.363 |
| Ulcer in participants>70% adherent† | 32 (34.0%) | 57 (37.3%) | 0.914 (0.645 to 1.295) | 0.61 |
| Ulcer in participants with reported activity reduction‡ | 3 (12.5%) | 57 (37.3%) | 0.336 (0.114 to 0.986) | 0.017 |
| Ulcer recurrence at alternative sites | ||||
| at previous ulcer site | 10 (6.6%) | 22 (14.4%) | 0.461 (0.226 to 0.939) | 0.028 |
| at measurement site | 23 (15.2%) | 36 (23.5%) | 0.647 (0.404 to 1.038) | 0.067 |
| at any foot site | 54 (35.8%) | 72 (47.1%) | 0.760 (0.579 to 0.997) | 0.046 |
| Serious adverse events | 0.154 | |||
| Deaths | 5 (3.3%) | 3 (2.0%) | 0.462 | |
| Hospital admissions | 37 (24.5%) | 28 (18.3%) | 0.187 |
Data are n (%). Effects are shown as relative risk ratio with 95% CI for enhanced therapy relative to usual care.
*Complicated foot ulcer defined as a University of Texas depth 3 (ie, bone contact) or grade B, C, or D (ie, infection and/or ischemia present); analysis on proportion of complicated ulcers of all ulcers at a primary site.
†Per-protocol analysis in which for the enhanced therapy group 93 participants who measured their foot temperature on 70% or more of all follow-up days were included.
‡Per-protocol analysis in which for the enhanced therapy group 24 participants who reported to have reduced their ambulatory activity when finding a hotspot were included
AMC, Academic Medical Center; UMC, University Medical Center; VUmc, Vrije Universiteit Medical Center.