Background
Methods
Setting
Study design
Population
Sample size
Instruments
Diabetic foot ulcers | Total (N = 209) | Magnitude of difference b | p-value | ||
---|---|---|---|---|---|
Yes (n = 45) | No (n = 164) | ||||
Age (years) | |||||
Mean ± SD | 56.7 ± 12.3 | 56.1 ± 11.6 | 56.2 ± 11.7 | 0.7 (−3.3–4.6) | 0.740 |
< 60 | 24 (54.5%) | 99 (61.5%) | 123 (60.0%) | – | 0.405 |
≥ 60 | 20 (45.5%) | 62 (38.5%) | 82 (40.0%) | 1.36 (0.69–2.66) | |
Weight (kg) | 88.8 ± 20.4 | 82.2 ± 20.2 | 83.6 ± 20.4 | 6.6 (−1.1–14.3) | 0.091 |
Height (cm) | 165.4 ± 8.7 | 161.8 ± 8.8 | 162.6 ± 8.9 | 3.6 (0.2–7.0) | 0.037 |
Body mass index | |||||
Mean ± SD | 32.7 ± 7.8 | 31.7 ± 7.6 | 31.9 ± 7.6 | 1.0 (−2.0–4.0) | 0.509 |
Normal | 4 (12.1%) | 19 (16.5%) | 23 (15.5%) | – | 0.743 |
Overweight | 11 (33.3%) | 32 (27.8%) | 43 (29.1%) | 1.72 (0.48–6.14) | |
Obese | 18 (54.5%) | 64 (55.7%) | 82 (55.4%) | 1.41 (0.43–4.64) | |
Gender | |||||
Male | 23 (51.1%) | 70 (42.7%) | 93 (44.5%) | 1.43 (0.74–2.78) | 0.314 |
Female | 22 (48.9%) | 94 (57.3%) | 116 (55.5%) | – | |
Marital status | |||||
Single | 3 (6.7%) | 7 (4.3%) | 10 (4.8%) | – | 0.197 |
Married | 33 (73.3%) | 132 (80.5%) | 165 (78.9%) | 0.75 (0.19–2.93) | |
Widow | 5 (11.1%) | 21 (12.8%) | 26 (12.4%) | 0.71 (0.14–3.65) | |
Divorced | 4 (8.9%) | 4 (2.4%) | 8 (3.8%) | 3.0 (0.45–20.15) | |
Educational level | |||||
Illiterate | 7 (16.3%) | 34 (21.4%) | 41 (20.3%) | – | 0.407 |
Less than high school | 17 (39.5%) | 43 (27.0%) | 60 (29.7%) | 1.92 (0.72–5.16) | |
High school | 10 (23.3%) | 37 (23.3%) | 47 (23.3%) | 1.31 (0.45–3.84) | |
University or above | 9 (20.9%) | 45 (28.3%) | 54 (26.7%) | 0.97 (0.33–2.87) | |
Occupation | |||||
Field job | 3 (6.7%) | 15 (9.1%) | 18 (8.6%) | 0.79 (0.21–3.02) | 0.651 |
Office job | 9 (20.0%) | 21 (12.8%) | 30 (14.4%) | 1.69 (0.66–4.31) | |
Housewife | 15 (33.3%) | 57 (34.8%) | 72 (34.4%) | 1.04 (0.48–2.24) | |
Not working | 18 (40.0%) | 71 (43.3%) | 89 (42.6%) | – | |
Monthly family income (SR) | |||||
< 5000 | 20 (47.6%) | 55 (36.2%) | 75 (38.7%) | – | 0.172 |
5000-9999 | 12 (28.6%) | 48 (31.6%) | 60 (30.9%) | 0.69 (0.31–1.55) | |
10,000-14,999 | 8 (19.0%) | 23 (15.1%) | 31 (16.0%) | 0.96 (0.37–2.48) | |
≥ 15,000 | 2 (4.8%) | 26 (17.1%) | 28 (14.4%) | 0.21 (0.05–0.97) | |
Number of family members | |||||
Mean ± SD | 6.8 ± 3.1 | 7.0 ± 3.4 | 7.0 ± 3.3 | −0.2 (−1.4–0.9) | 0.718 |
Living alone | |||||
No | 39 (86.7%) | 143 (88.3%) | 182 (87.9%) | – | 0.770 |
Yes | 6 (13.3%) | 19 (11.7%) | 25 (12.1%) | 1.16 (0.43–3.10) |
Diabetic foot ulcers | Total (N = 209) | Magnitude of difference b | p-value | ||
---|---|---|---|---|---|
Yes (n = 45) | No (n = 164) | ||||
Type of diabetes | |||||
Type 1 | 4 (8.9%) | 33 (20.1%) | 37 (17.7%) | 0.21 (0.06–0.75) | 0.033 |
Type 2 | 29 (64.4%) | 110 (67.1%) | 139 (66.5%) | 0.46 (0.20–1.05) | |
Unknown | 12 (26.7%) | 21 (12.8%) | 33 (15.8%) | – | |
HbA1c | |||||
Mean ± SD | 9.9 ± 2.7 | 8.4 ± 2.0 | 8.6 ± 2.2 | 1.5 (0.3–2.7) | 0.016 |
≥ 8 | 18 (78.3%) | 53 (54.1%) | 71 (58.7%) | 3.06 (1.05–8.89) | 0.034 |
< 8 | 5 (21.7%) | 45 (45.9%) | 50 (41.3%) | – | |
Age at diagnosis of diabetes | 37.6 ± 12.0 | 42.7 ± 12.0 | 41.6 ± 12.1 | −5.1 (−9.1--1.1) | 0.014 |
Family history of diabetes | |||||
No | 14 (31.1%) | 46 (28.0%) | 60 (28.7%) | – | 0.688 |
Yes | 31 (68.9%) | 118 (72.0%) | 149 (71.3%) | 0.86 (0.42–1.77) | |
Symptoms | |||||
Peripheral tingling | 23 (52.3%) | 68 (42.5%) | 91 (44.6%) | 1.48 (0.76–2.89) | 0.248 |
Peripheral numbness | 35 (79.5%) | 78 (48.8%) | 113 (55.4%) | 4.09 (1.85–9.06) | < 0.001 |
Peripheral hypo- or hyperthermia | 20 (45.5%) | 70 (43.8%) | 90 (44.1%) | 1.07 (0.55–2.10) | 0.840 |
Peripheral painlessness | 17 (38.6%) | 16 (10.0%) | 33 (16.2%) | 5.67 (2.55–12.57) | < 0.001 |
Peripheral edema | 10 (22.7%) | 39 (24.4%) | 49 (24.0%) | 0.91 (0.41–2.02) | 0.821 |
Tiredness without working | 15 (34.1%) | 80 (50.0%) | 95 (46.6%) | 0.52 (0.26–1.04) | 0.061 |
Blurred vision | 20 (45.5%) | 54 (33.8%) | 74 (36.3%) | 1.64 (0.83–3.22) | 0.153 |
Nocturnal dyspnea | 4 (9.1%) | 27 (16.9%) | 31 (15.2%) | 0.49 (0.16–1.49) | 0.203 |
Loss of concentration | 13 (29.5%) | 35 (21.9%) | 48 (23.5%) | 1.50 (0.71–3.17) | 0.288 |
Amputation | 10 (22.7%) | 0 (0.0%) | 10 (4.9%) | NA | < 0.001 |
Number of comorbid diseases | |||||
Mean ± SD | 2.9 ± 1.9 | 2.8 ± 2.0 | 2.8 ± 2.0 | 0.1 (−0.5–0.8) | 0.702 |
None | 5 (11.1%) | 19 (11.7%) | 24 (11.5%) | – | 0.715 |
One or two | 16 (35.6%) | 68 (41.7%) | 84 (40.4%) | 0.89 (0.29–2.76) | |
Three or more | 24 (53.3%) | 76 (46.6%) | 100 (48.1%) | 1.20 (0.41–3.56) | |
Comorbidity | |||||
Hypercholesterolemia | 20 (44.4%) | 97 (59.5%) | 117 (56.3%) | 0.54 (0.28–1.06) | 0.071 |
Hypertension | 28 (62.2%) | 76 (46.6%) | 104 (50.0%) | 1.89 (0.96–3.71) | 0.064 |
Joint diseases | 10 (22.2%) | 61 (37.4%) | 71 (34.1%) | 0.48 (0.22–1.03) | 0.057 |
Cataracts | 11 (24.4%) | 32 (19.6%) | 43 (20.7%) | 1.32 (0.61–2.90) | 0.480 |
Cardiovascular diseases | 12 (26.7%) | 29 (17.8%) | 41 (19.7%) | 1.68 (0.78–3.64) | 0.185 |
Retinal disease | 14 (31.1%) | 20 (12.3%) | 34 (16.3%) | 3.23 (1.47–7.08) | 0.002 |
Gastrointestinal disease | 5 (11.1%) | 26 (16.0%) | 31 (14.9%) | 0.66 (0.24–1.83) | 0.420 |
Lung disease | 5 (11.1%) | 24 (14.7%) | 29 (13.9%) | 0.72 (0.26–2.02) | 0.536 |
Anemia | 4 (8.9%) | 25 (15.3%) | 29 (13.9%) | 0.54 (0.18–1.64) | 0.269 |
Renal disease | 4 (8.9%) | 15 (9.2%) | 19 (9.1%) | 0.96 (0.30–3.06) | > 0.99 |
Others | 14 (31.1%) | 34 (20.9%) | 48 (23.1%) | 2.14 (0.68–6.74) | 0.148 |
Diabetic foot ulcers | Total (N = 209) | Magnitude of difference b | p-value | ||
---|---|---|---|---|---|
Yes (n = 45) | No (n = 164) | ||||
Family history of psychiatric illness | |||||
No | 36 (90.0%) | 141 (88.1%) | 177 (88.5%) | – | > 0.99 |
Yes | 4 (10.0%) | 19 (11.9%) | 23 (11.5%) | 0.83 (0.26–2.58) | |
Visit to psychiatrist | |||||
No | 33 (75.0%) | 149 (90.9%) | 182 (87.5%) | – | 0.005 |
Yes | 11 (25.0%) | 15 (9.1%) | 26 (12.5%) | 3.31 (1.40–7.86) | |
Psychological/behavioral therapy | |||||
No | 33 (82.5%) | 149 (93.1%) | 182 (91.0%) | – | 0.058 |
Yes | 7 (17.5%) | 11 (6.9%) | 18 (9.0%) | 2.87 (1.04–7.97) | |
Psychiatric medications | |||||
No | 30 (75.0%) | 148 (93.1%) | 178 (89.4%) | – | 0.002 |
Yes | 10 (25.0%) | 11 (6.9%) | 21 (10.6%) | 4.49 (1.75–11.50) | |
Social support from family or friends | |||||
No | 10 (25.0%) | 33 (20.8%) | 43 (21.6%) | – | 0.062 |
Yes | 29 (72.5%) | 99 (62.3%) | 128 (64.3%) | 0.97 (0.43–2.19) | |
Somewhat | 1 (2.5%) | 27 (17.0%) | 28 (14.1%) | 0.12 (0.02–1.02) | |
Psychological deterioration after diagnosis of diabetes | |||||
No | 21 (52.5%) | 93 (58.1%) | 114 (57.0%) | – | 0.771 |
Yes | 10 (25.0%) | 38 (23.8%) | 48 (24.0%) | 1.17 (0.50–2.71) | |
Somewhat | 9 (22.5%) | 29 (18.1%) | 38 (19.0%) | 1.37 (0.57–3.33) | |
Improved family relationship after diagnosis of diabetes | |||||
No | 9 (22.5%) | 54 (33.8%) | 63 (31.5%) | – | 0.216 |
Yes | 23 (57.5%) | 68 (42.5%) | 91 (45.5%) | 2.03 (0.87–4.75) | |
Somewhat | 8 (20.0%) | 38 (23.8%) | 46 (23.0%) | 1.26 (0.45–3.57) | |
Quality of life; WHOQOL-BREF (mean ± SD) | |||||
Domain 1: Physical health | 67.1 ± 19.2 | 71.1 ± 16.4 | 70.2 ± 17.1 | −4.0 (−9.7–1.7) | 0.263 |
Domain 2: Psychological | 75.4 ± 14.9 | 78.0 ± 13.3 | 77.4 ± 13.7 | −2.6 (−7.1–2.0) | 0.384 |
Domain 3: Social relationships | 77.3 ± 16.5 | 77.5 ± 17.5 | 77.4 ± 17.3 | −0.2 (−5.9–5.5) | 0.712 |
Domain 4: Environment | 75.1 ± 16.7 | 74.7 ± 13.8 | 74.8 ± 14.5 | 0.4 (−4.4–5.2) | 0.672 |
Overall quality of life and general health | 75.6 ± 13.2 | 75.1 ± 17.2 | 75.2 ± 16.4 | 0.4 (−5.0–5.9) | 0.891 |
Total: All above domains | 73.2 ± 12.4 | 74.8 ± 12.0 | 74.4 ± 12.1 | −1.5 (− 5.5–2.5) | 0.539 |
Anxiety; HAD anxiety | |||||
Mean ± SD | 4.7 ± 4.6 | 4.1 ± 4.4 | 4.2 ± 4.5 | 0.6 (−0.9–2.1) | 0.355 |
Normal 0–7 | 34 (75.6%) | 134 (81.7%) | 168 (80.4%) | – | 0.357 |
Anxiety > 7 | 11 (24.4%) | 30 (18.3%) | 41 (19.6%) | 1.45 (0.66–3.17) | |
Depression; HAD depression | |||||
Mean ± SD | 5.7 ± 4.3 | 4.7 ± 3.7 | 4.9 ± 3.9 | 1.0 (−0.3–2.3) | 0.200 |
Normal 0–7 | 30 (66.7%) | 127 (77.4%) | 157 (75.1%) | – | 0.139 |
Depression > 7 | 15 (33.3%) | 37 (22.6%) | 52 (24.9%) | 1.72 (0.84–3.53) | |
Somatic symptoms; PHQ-15 | |||||
Mean ± SD | 6.8 ± 5.7 | 8.5 ± 6.2 | 8.1 ± 6.1 | −1.6 (−3.7–0.4) | 0.114 |
Minimal severity (0–4) | 18 (40.0%) | 59 (36.0%) | 77 (36.8%) | – | 0.213 |
Low severity (5–9) | 16 (35.6%) | 40 (24.4%) | 56 (26.8%) | 1.31 (0.60–2.87) | |
Medium severity (10–14) | 7 (15.6%) | 33 (20.1%) | 40 (19.1%) | 0.70 (0.26–1.84) | |
High severity (≥15) | 4 (8.9%) | 32 (19.5%) | 36 (17.2%) | 0.41 (0.13–1.32) | |
Self-Management; SDSCA (mean ± SD) | |||||
Diet | 44.8 ± 39.3 | 29.2 ± 36.9 | 32.6 ± 37.9 | 15.5 (3.1–28.0) | 0.011 |
Exercise | 17.1 ± 26.1 | 18.7 ± 27.2 | 18.4 ± 26.9 | −1.6 (−10.5–7.4) | 0.351 |
Blood sugar testing | 55.4 ± 37.9 | 36.1 ± 37.2 | 40.2 ± 38.1 | 19.3 (6.9–31.7) | 0.003 |
Foot care | 50.8 ± 35.7 | 23.4 ± 33.7 | 29.2 ± 35.9 | 27.4 (16.0–38.8) | < 0.001 |
Total | 42.2 ± 20.3 | 27.2 ± 21.2 | 30.4 ± 21.8 | 15.0 (8.0–22.0) | < 0.001 |
Instrument validation
Outcome evaluation
Statistical analysis
Unstandardized beta | Standard error of beta | 95% confidence interval (CI) | p-value | ||
---|---|---|---|---|---|
Lower CI | Upper CI | ||||
Anxiety; HAD anxiety | −0.034 | 0.029 | −0.094 | 0.025 | 0.251 |
Depression; HAD depression | −0.069 | 0.030 | −0.129 | −0.009 | 0.026 |
Somatic symptoms; PHQ-15 | −0.046 | 0.037 | −0.120 | 0.029 | 0.224 |
Self-management; SDSCA | 0.036 | 0.032 | −0.029 | 0.102 | 0.270 |
Diabetic foot ulcer | 0.989 | 1.059 | 0.882 | 1.108 | 0.848 |
Results
Demographic characteristics by diabetic foot ulcer group
Clinical characteristics by diabetic foot ulcer group
Psychological determinants by diabetic foot ulcer group
The correlations of quality of life with psychosocial determinants
Physical health | Psychological | Social relationships | Environment | Overall | Total (all domains) | |
---|---|---|---|---|---|---|
DM with DF | ||||||
Anxiety; HAD anxiety | − 0.381** | − 0.363* | − 0.104 | − 0.396** | − 0.488** | − 0.494** |
Depression; HAD depression | − 0.565** | − 0.512** | − 0.212 | − 0.453** | − 0.552** | − 0.624** |
Somatic symptoms; PHQ-15 | −0.353* | − 0.179 | − 0.109 | − 0.321* | −0.197 | − 0.401** |
Self-management; SDSCA | ||||||
Diet | −0.133 | 0.243 | 0.070 | 0.049 | 0.441** | 0.065 |
Exercise | 0.132 | −0.001 | 0.156 | 0.192 | 0.313* | 0.190 |
Blood sugar testing | −0.159 | − 0.109 | − 0.095 | 0.118 | − 0.083 | − 0.085 |
Foot care | 0.155 | 0.106 | −0.100 | 0.129 | 0.102 | 0.203 |
Total | −0.010 | 0.139 | −0.021 | 0.189 | 0.334* | 0.161 |
Number of comorbid diseases | 0.096 | 0.047 | −0.039 | − 0.065 | − 0.020 | − 0.018 |
DM without DF | ||||||
Anxiety; HAD anxiety | −0.562** | − 0.547** | − 0.350** | −0.362** | − 0.365** | −0.587** |
Depression; HAD depression | −0.521** | −0.488** | − 0.411** | −0.385** | − 0.341** | −0.574** |
Somatic symptoms; PHQ-15 | −0.654** | −0.462** | − 0.324** | −0.368** | − 0.352** | −0.582** |
Self-management; SDSCA | ||||||
Diet | 0.078 | 0.127 | 0.052 | 0.156* | 0.084 | 0.108 |
Exercise | 0.226** | 0.005 | −0.043 | 0.073 | 0.034 | 0.109 |
Blood sugar testing | −0.087 | −0.049 | 0.101 | −0.007 | − 0.033 | −0.064 |
Foot care | 0.006 | 0.138 | 0.146 | 0.144 | 0.109 | 0.127 |
Total | 0.036 | 0.080 | 0.059 | 0.111 | 0.057 | 0.068 |
Number of comorbid diseases | −.411** | −0.149 | −0.120 | −0.106 | −0.086 | − 0.253** |
Total | ||||||
Anxiety; HAD anxiety | −0.525** | −0.509** | − 0.293** | −0.368** | − 0.387** | −0.559** |
Depression; HAD depression | −0.534** | −0.491** | − 0.376** | −0.397** | − 0.382** | −0.582** |
Somatic symptoms; PHQ-15 | −0.575** | −0.396** | − 0.274** | −0.358** | − 0.319** | −0.532** |
Self-management; SDSCA | ||||||
Diet | 0.016 | 0.135 | 0.038 | 0.127 | 0.148* | 0.084 |
Exercise | 0.212** | 0.009 | 0.006 | 0.094 | 0.092 | 0.137* |
Blood sugar testing | −0.118 | −0.065 | 0.050 | 0.024 | −0.046 | −0.073 |
Foot care | −0.002 | 0.099 | 0.085 | 0.136 | 0.087 | 0.111 |
Total | 0.010 | 0.073 | 0.048 | 0.140* | 0.095 | 0.079 |
Number of comorbid diseases | −.300** | −0.105 | −0.106 | − 0.092 | −0.075 | − 0.201** |