Group | |||
---|---|---|---|
Placebo | Auto-BM-MNC | Allo-WJ-MSCs | |
Glycated hemoglobin A1c (%) at the start of the study | |||
Mean ± SD | 7.83 ± 1.95 | 6.51 ± 0.59 | 7.26 ± 1.50 |
Median | 7.8 | 6.4 | 7.2 |
Min/max | 5.9/9.8 | 5.8/7.4 | 5.8/8.8 |
Lipid profile at the start of the study | |||
Total cholesterol | |||
Mean ± SD | 139 ± 29.70 | 160.4 ± 18.37 | 128.8 ± 27.30 |
Median | 139 | 155.7 | 133.8 |
Min/max | 118/160 | 139/184 | 88.30/164.3 |
High-density lipoprotein cholesterol | |||
Mean ± SD | 38 ± 5.65 | 41.67 ± 13.22 | 43.14/15.57 |
Median | 38 | 44.90 | 40.70 |
Min/max | 31/42 | 25/58.20 | 24.30/67.40 |
Triglycerides | |||
Mean ± SD | 146.5 ± 3.53 | 221.8 ± 165.3 | 162.4 ± 71.98 |
Median | 146.5 | 157.3 | 148.1 |
Min/max | 144/149 | 75.20/442 | 98.20/274.6 |
Basal Rutherford classification | |||
Stage 2, n (%) | – | 1 (14) | – |
Stage 3, n (%) | – | – | 1 (16) |
Stage 4, n (%) | 2 (22) | – | 2 (34) |
Stage 5, n (%) | 7 (78) | 6 (86) | 2 (34) |
Stage 6, n (%) | – | – | 1 (16) |
Basal TcPO2 (mmHg) | |||
Mean ± SD | 16.89 ± 9.88 | 8.28 ± 5.25 | 15 ± 9.35 |
Median | 19 | 7 | 13 |
Min/max | 4/30 | 4/18 | 6/28 |
Basal presence of ulcers (cm2) | |||
n (%) | 8 (89) | 6 (86) | 5 (84) |
Mean ± SD | 1.643 ± 1.064 | 3.22 ± 3.63 | 7.95 ± 15.20 |
Median | 1.735 | 2.57 | 1.5 |
Min/max | 0.3/2.8 | 0.07/10.03 | 0.42/35.12 |
Basal visual pain scale | |||
Mean ± SD | 8.66 ± 2.29 | 4.28 ± 3.49 | 8.25/0.95 |
Median | 10 | 4 | 8.5 |
Min/max | 3/10 | 0/9 | 7/9 |
Basal pain-free walking distance (meters) | |||
Mean ± SD | 28.33 ± 40.77 | 445.7 ± 544.6 | 12.50 ± 25 |
Median | 10 | 100 | 0 |
Min/max | 0/100 | 20/1500 | 0/50 |
Basal quality of life | |||
Mean ± SD | 8.70 ± 0.67 | 12.29 ± 2.43 | 10 ± 1.29 |
Median | 9 | 12 | 10 |
Min/max | 8/10 | 9/15 | 8/12 |