Summary of primary and secondary outcomes by TM and SOC within 12 months of recruitment
| . | TM . | SOC . | Mean difference (95% CI)a . | SHRb . |
|---|---|---|---|---|
| n | 94 | 88 | ||
| Primary outcome | ||||
| Patients whose ulcer healed | 75 (79.8) | 67 (76.1) | ||
| Time to healing within 12 months (months) | 3.4 ± 3.2 | 3.8 ± 3.4 | −0.43 (–1.50, 0.65) | 1.16 (0.85, 1.59) |
| Secondary outcomes | ||||
| Amputations before ulcer healing | 6 (6.4) | 13 (14.8) | −8.3% (–16.3, –0.5) | |
| Deaths before ulcer healing | 5 (5.3) | 5 (5.7) | −0.4% (–6.5, 5.7) | |
| Secondary outcomes | ||||
| Consultations at the outpatient clinic (per month) | 2.0 ± 1.9 | 2.5 ± 3.0 | −0.48 (–1.46, 0.49) | |
| Consultations by community nurse (per month) | 6.7 ± 3.4 | 5.9 ± 4.6 | 0.92 (–0.70, 2.53) | |
| Secondary outcomes | ||||
| GS-PEQc | 4.4 ± 0.5 | 4.4 ± 0.5 | 0.07 (–0.10, 0.24) |
| . | TM . | SOC . | Mean difference (95% CI)a . | SHRb . |
|---|---|---|---|---|
| n | 94 | 88 | ||
| Primary outcome | ||||
| Patients whose ulcer healed | 75 (79.8) | 67 (76.1) | ||
| Time to healing within 12 months (months) | 3.4 ± 3.2 | 3.8 ± 3.4 | −0.43 (–1.50, 0.65) | 1.16 (0.85, 1.59) |
| Secondary outcomes | ||||
| Amputations before ulcer healing | 6 (6.4) | 13 (14.8) | −8.3% (–16.3, –0.5) | |
| Deaths before ulcer healing | 5 (5.3) | 5 (5.7) | −0.4% (–6.5, 5.7) | |
| Secondary outcomes | ||||
| Consultations at the outpatient clinic (per month) | 2.0 ± 1.9 | 2.5 ± 3.0 | −0.48 (–1.46, 0.49) | |
| Consultations by community nurse (per month) | 6.7 ± 3.4 | 5.9 ± 4.6 | 0.92 (–0.70, 2.53) | |
| Secondary outcomes | ||||
| GS-PEQc | 4.4 ± 0.5 | 4.4 ± 0.5 | 0.07 (–0.10, 0.24) |
Data are n (%) or mean ± SD unless otherwise indicated.
aMean difference adjusted for clustering using linear mixed models for continuous outcomes and difference in proportions estimated using generalized linear models with robust SEs for dichotomous outcomes.
bEstimated using competing risk regression with robust SEs to adjust for clustering. The SOC group is the reference group.
cTotal score for each patient calculated as the mean of the responses (range 1–5).