Table 2.
Overall Baseline Demographics and Clinical Characteristics in the 2 Groups.
| Intervention group (n = 16) | Control group (n = 17) | P-value | OR (95% CI) | |
|---|---|---|---|---|
| Demographics | ||||
| Age (years) | 65.1 ± 13.8 | 61.4 ± 11.2 | 0.400 | – |
| Male (no.) | 10 (62.5%) | 11 (64.7%) | 0.895 | 0.909 (0.220-3.758) |
| BMI (kg/m2) | 32.5 ± 9.2 | 29.2 ± 4.8 | 0.194 | – |
| Obesity (BMI ≥ 30) | 9 (56.3%) | 7 (41.2%) | 0.387 | 1.837 (0.461-7.312) |
| Clinical characteristics | ||||
| DM type 2 | 16 (100%) | 17 (100%) | 1.000 | – |
| HbA1C (% mmol/mol) | 8.0 ± 2.0 | 8.1 ± 1.5 | 0.791 | – |
| HbA1C >9 | 3/15 (20.0%) | 4/17 (23.5%) | 0.810 | 0.813 (0.150-4.404) |
| CKD <stage 5 (no.) | 5 (31.3%) | 8 (47.1%) | 0.353 | 0.511 (0.123-2.122) |
| DLP | 7 (43.8%) | 6 (35.3%) | 0.619 | 1.426 (0.351-5.793) |
| CAD | 5 (31.3%) | 5 (29.4%) | 0.909 | 1.091 (0.247-4.817) |
| CHF | 4 (25.0%) | 3 (17.6%) | 0.606 | 1.556 (0.289-8.379) |
| Anemia | 2 (12.5%) | 6 (35.3%) | 0.127 | 0.262 (0.044-1.560) |
| PAD | 9 (56.3%) | 9 (52.9%) | 0.849 | 1.143 (0.290-4.507) |
| TSFI (score) | 0.26 ± 0.13 | 0.24 ± 0.11 | 0.678 | – |
| Frail (no.) | 5/13 (38.5%) | 4/15 (26.7%) | 0.505 | 1.719 (0.347-8.508) |
| Prev. minor amp | 11 (68.8%) | 13 (76.5%) | 0.619 | 0.677 (0.145-3.159) |
| Prev. recanalization | 7 (43.8%) | 7 (41.2%) | 0.881 | 1.111 (0.279-4.423) |
| <180 days | 5 (31.3%) | 4 (23.5%) | 0.619 | 1.477 (0.317-6.895) |
| >180 days | 2 (12.5%) | 2 (11.8%) | 0.948 | 1.071 (0.132-8.670) |
| Daily prescribed meds (no.) | 9.81 ± 5.6 | 11.5 ± 5.3 | 0.389 | – |
| Wound characteristics | ||||
| WIfI stage | 0.509 | – | ||
| Stage 3/4 | 2 (12.5) | 1 (5.9) | ||
| Stage 1/2 | 14 (87.5) | 16 (94.1) | ||
| Wound area (cm2) | 7.4±8.5 | 3.1 ± 5.6 | 0.035 | – |
| Wound depth (mm) | 3.0 ± 2.1 | 3.2 ± 2.4 | 0.825 | – |
| WBC (no.) | 14/15 (93.3%) | 15/17 (88.2%) | 0.164 | – |
| None | 13/14 (92.9) | 11/15 (73.3%) | ||
| Rare-few | 1/14 (7.1%) | 4/15 (26.7%) | ||
| Mod-abund | 0/14 (0%) | 0/15 (0%) | ||
| Vascular & Neuropathic characteristics | ||||
| SPP (mmHg) | 71.0 ± 12.2 | 78.1 ± 18.6 | 0.211 | – |
| Tissue O2 (SatO2 %) | 69.3 ± 21.3 | 73.1 ± 13.5 | 0.971 | – |
| VPT (Volts) | 25.6 ± 17.2 | 25.9 ± 17.8 | 0.975 | – |
| Peripheral neuropathy, VPT>25 Volts (no.) |
7/15 (46.7%) | 6/13 (46.2%) | 0.978 | 1.021 (0.230-4.526) |
| ABI (ratio) | 0.8 ± 0.3 | 0.9 ± 0.5 | 0.677 | – |
| Moderate-severe PAD, ABI<0.8 or >1.40 (no.) |
6/12 (50%) | 6/13 (46.2%) | 0.848 | 1.167 (0.242-5.616) |
| Patient self-report metrics | ||||
| Concern for fall (FES-I score) | 28.8 ± 11.9 | 22.4 ± 4.9 | 0.287 | – |
| High concern, FES-I≥ 28, (no.) |
5/14 (35.7%) | 3/16 (18.8%) | 0.295 | 2.407 (0.456-12.720) |
| Depression (CES-D score) | 9.9 ± 6.4 | 5.3 ± 5.5 | 0.048 | – |
| Depressed, CES-D≥ 16 (no.) |
3/15 (20.0%) | 0/16 (0.0%) | 0.060 | – |
| Cognitive function (MoCA score) | 23.2 ± 4.4 | 24.7 ± 4.3 | 0.302 | – |
| Cognitive impaired, MoCA≤ 25,(no.) |
11/16 (73.3%) | 8/17 (50%) | 0.183 | 2.750 (0.610-12.407) |
| Sleep deprivation (PSQI score) |
7.7 ± 5.4 | 8.6 ± 6.2 | 0.683 | – |
| Clinical insomnia, PSQI>5 (no.) |
9/15 (60%) | 12/17 (70.5%) | 0.755 | 1.250 (0.308-5.072) |
| Pain (VAS, score) | 0.9 ± 1.6 | 2.2 ± 3.2 | 0.428 | – |
Values are presented as mean±standard deviation (SD) or n (%).
Abbreviations. DM, diabetes mellitus; HbA1c, glycated hemoglobin; CKD, chronic kidney disease; DLP, dyslipidemia; CAD, coronary artery disease; CHF, congestive heart failure; PAD, peripheral artery disease; TSFI, trauma specific frailty index; Prev., previous; amp, amputation; WIfI: wound/ischemia/foot infection; SPP, skin perfusion pressure; VPT: vibration perception threshold; ABI, ancle brakial index; WBC: white blood cell count obtained by wound culture; mod, moderate; abund, abundant; FES-I: falls efficacy scale international, CES-D: center for epidemiologic studies depression; MoCA: montreal cognitive assessment; PSQI: pittsburgh sleep quality index; VAS: pain visual analog scale.