Table 1
Clinical characteristics of the studied population of patients
| Parameter | Group I treated with OXYBAR-IA-S device | Group II treated with LASEROBAR-IA-S device | Statistical significance |
|---|---|---|---|
| Women | 7 (38.9%) | 7 (38.9%) | p=1.000 |
| Men | 11 (61.1%) | 11 (61.1%) | |
| Age | 70.94 ± 10.86 | 66.83 ± 7.20 | p=0.055 |
| Diabetes | 7 (38.9%) | 9 (50.0%) | p=0.170 |
| Venous insufficiency | 9 (50.0%) | 8 (44.4%) | p=0.740 |
| Atherosclerosis | 15 (83.3%) | 17 (94.4%) | p=0.280 |
| Bacterial contamination | 16 (88.9%) | 14 (77.8%) | p=0.365 |
Table 2
Comparison of ulceration surface areas measured by means of planimetric method (mean ± SD) in patients from both study groups before the beginning of therapeutic cycle and after its completion, with statistical assessment
| Group | Surface area before the therapeutic cycle (average± SD) | Surface area after the therapeutic cycle (average± SD) | Statistical significance |
|---|---|---|---|
| Group I treated with OXYBARIA-S device | 25.11 ± 17.8 | 16.93 ± 13.89 | p=0.0002 |
| Group II treated with LASEROBARIA-S device | 34.17 ± 14.82 | 23.99 ± 15.15 | p=0.004 |
| Statistical significance Group I vs. Group II | p=0.071 | p=0.169 |
Table 3
Comparison of selected blood morphology parameters (mean± SD) in patients from both study groups, before the beginning of therapeutic cycle and after its completion, with statistical evaluation
| Parameter | Group I treated with OXYBARIA-S device | Group II treated with LASEROBARIA-S device | Statistical significance Group I vs. Group II |
|---|---|---|---|
| Leukocytes [G/l] before treatment after treatment | 8.02±2.63 6.81±2.15 | 8.30±2.33 7.26±1.56 | p=0.709 p=0.484 |
| Statistical significance before treatment vs after treatment | p=0.35 | p=0.01 | |
| Erythrocytes [T/l] before treatment after treatment | 4.28±0.65 4.13±0.70 | 4.40±0.54 4.17±0.49 | p=0.660 p=0.846 |
| Statistical significance before treatment vs after treatment | p=0.23 | p=0.21 | |
| Hemoglobin [g/dl] before treatment after treatment | 12.22 ± 1.79 11.82 ± 1.96 | 12.70 ± 1.59 12.10 ± 1.87 | p=0.425 p=0.666 |
| Statistical significance before treatment vs after treatment | p=0.08 | p=0.22 | |
| Haematocrit [%] before treatment after treatment | 37.71 ± 5.40 36.81 ± 6.07 | 39.70 ± 5.07 37.38 ± 5.65 | p=0.259 p=0.769 |
| Statistical significance before treatment vs after treatment | p=0.52 | p=0.19 | |
| MCV [fl] before treatment after treatment | 88.57 ± 6.89 89.37 ± 5.75 | 91.10 ± 5.01 89.43 ± 6.75 | p=0.222 p=0.977 |
| Statistical significance before treatment vs after treatment | p=0.53 | p=0.72 | |
| MCH [pg] before treatment after treatment | 28.78 ± 3.02 28.69 ± 1.85 | 29.10 ± 2.00 29.97 ± 2.71 | p=0.698 p=0.722 |
| Statistical significance before treatment vs after treatment | p=0.63 | p=0.80 | |
| MCHC [g/dl] before treatment after treatment | 32.44 ± 1.16 32.13 ± 1.14 | 32.00 ± 1.39 32.36 ± 1.14 | p=0.264 p=0.561 |
| Statistical significance before treatment vs after treatment | p=0.63 | p=0.87 | |
| RDW-CV [%] before treatment after treatment | 13.77 ± 1.65 13.56 ± 1.29 | 13.70 ± 1.53 13.51 ± 1.85 | p=0.942 p=0.926 |
| Statistical significance before treatment vs after treatment | p=0.90 | p=0.36 | |
| Platelets [tys./µl] before treatment after treatment | 271.3 ± 157.7 248.6 ± 208.2 | 248.9 ± 75.8 229.5 ± 67.9 | p=0.591 p=0.713 |
| Statistical significance before treatment vs after treatment | p=0.39 | p=0.54 | |
| MPV [fl] before treatment after treatment | 6.75 ± 1.29 6.86 ± 1.23 | 7.00 ± 0.91 6.72 ± 0.86 | p=0.434 p=0.685 |
| Statistical significance before treatment vs after treatment | p=0.61 | p=0.66 | |
| Neutrophils [%] before treatment after treatment | 67.11 ± 8.01 58.88 ± 10.26 | 63.10 ± 10.32 56.64 ± 9.86 | p=0.199 p=0.509 |
| Statistical significance before treatment vs after treatment | p=0.73 | p=0.01 | |
| Lymphocytes [%] before treatment after treatment | 21.81 ± 6.50 26.24 ± 9.95 | 25.90 ± 9.72 31.02 ± 9.75 | p=0.150 p=0.155 |
| Statistical significance before treatment vs after treatment | p=0.79 | p=0.05 | |
| Monocytes [%] before treatment after treatment | 7.73 ± 2.19 8.47 ± 2.68 | 7.00 ± 2.05 7.71 ± 1.97 | p=0.289 p=0.083 |
| Statistical significance before treatment vs after treatment | p=0.01 | p=0.01 | |
| Eosinophils [%] before treatment after treatment | 2.51 ± 3.34 4.26 ± 2.65 | 3.30 ± 2.39 3.77 ± 1.79 | p=0.427 p=0.516 |
| Statistical significance before treatment vs after treatment | p=0.15 | p=0.01 | |
| Basophils [%] before treatment after treatment | 0.70 ± 0.15 0.96 ± 0.35 | 0.80 ± 0.20 0.87 ± 0.24 | p=0.346 p=0.364 |
| Statistical significance before treatment vs after treatment | p=0.58 | p=0.43 |
Table 4
Comparison of selected blood coagulation parameters (mean ± SD) in patients from both study groups, before the beginning of therapeutic cycle and after its completion, with statistical evaluation
| Parameter | Group I treated with OXYBARIA-S device | Group II treated with LASEROBARIA-S device | Statistical significance Group I vs Group II |
|---|---|---|---|
| Fibrinogen [g/l] before treatment after treatment | 4.22±1.28 3.39 ± 0.68 | 4.05±1.36 3.5 ± 0.71 | p=0.708 p=0.569 |
| Statistical significance before treatment vs after treatment | p=0.01 | p<0.001 | |
| Kaolin-cephalintime (aPTT)[s] before treatment after treatment | 33.76±9.77 37.19 ± 11.97 | 31.85±9.42 31.4 ± 10.17 | p=0.554 p=0.130 |
| Statistical significance before treatment vs after treatment | p=0.16 | p=0.45 | |
| Prothrombin time[s] before treatment after treatment | 11.75±0.90 11.75 ± 0.90 | 11.80±1.10 12.0 ± 0.60 | p=0.704 p=0.287 |
| Statistical significance before treatment vs after treatment | p=0.19 | p=0.29 | |
| International Normalized Ratio (INR) before treatment after treatment | 1.15±0.25 1.20 ± 0.20 | 1.10±0.15 1.21 ± 0.12 | p=0.751 p=0.282 |
| Statistical significance before treatment vs after treatment | p=0.20 | p=0.35 |
Table 5
Comparison of selected biochemical parameters (mean ± SD) in blood serum of patients from both study groups, before the beginning of therapeutic cycle and after its completion, with statistical evaluation
| Parameter | Group I treated With OXYBARIA-S | Group II treated with LASEROBARIA-S | Statistical significance Group I vs Group II |
|---|---|---|---|
| Glucose [mg/dl] before treatment after treatment | 105.45 ±7.55 91.50±9.45 | 101.60± 12.55 100.1± 12.43 | p=0.880 p=0.067 |
| Statistical significance before treatment vs after treatment | p=0.04 | p=0.08 | |
| Total cholesterol[mg/dl] before treatment after treatment | 140.83±33.31 134.39±34.40 | 146.33±38.82 138.5±27.58 | p=0.842 p=0.695 |
| Statistical significance before treatment vs after treatment | p=0.59 | p=0.04 | |
| Cholesterol-LDL[mg/dl] before treatment after treatment | 85.78±33.35 81.33±33.19 | 107.56±31.41 84.2±25.10 | p=0.052 p=0.770 |
| Statistical significance before treatment vs after treatment | p=0.68 | p=0.06 | |
| Cholesterol-HDL[mg/dl] before treatment after treatment | 45.89±9.97 41.22±9.53 | 51.26±12.42 43.6±8.22 | p=0.162 p=0.424 |
| Statistical significance before treatment vs after treatment | p=0.22 | p=0.03 | |
| Triglycerides [mg/dl] before treatment after treatment | 107.72±32.09 117.44±39.83 | 119.06±55.01 114.6±39.13 | p=0.455 p=0.831 |
| Statistical significance before treatment vs after treatment | p=0.50 | p=0.80 | |
| Total protein[g/dl] before treatment after treatment | 7.22±0.60 6.69±0.46 | 7.00±0.71 6.60 ±0.65 | p=0.319 p=0.585 |
| Statistical significance before treatment vs after treatment | p=0.01 | p=0.01 | |
| Sodium [mmol/l] before treatment after treatment | 139.44±2.57 137.89±4.59 | 138.94±3.02 139.8±3.45 | p=0.596 p=0.160 |
| Statistical significance before treatment vs after treatment | p=0.24 | p=0.69 | |
| Potassium [mmol/l] before treatment after treatment | 4.83±0.53 4.64±0.55 | 4.58±0.50 4.40 ±0.38 | p=0.149 p=0.122 |
| Statistical significance before treatment vs after treatment | p=0.23 | p=0.09 | |
| Creatinine [mg/dl] before treatment after treatment | 0.93±1.94 0.88±0.15 | 0.96±0.13 1.00 ±0.16 | p=0.776 p=0.281 |
| Statistical significance before treatment vs after treatment | p=0.82 | p=0.74 | |
| Urea [mg/dl] before treatment after treatment | 43.45±11.1 45.55±15.04 | 34.85±12.40 38.90 ±5.42 | p=0.704 p=0.248 |
| Statistical significance before treatment vs after treatment | p=0.46 | p=0.70 | |
| Uricacid [mg/dl] before treatment after treatment | 6.28±1.29 6.29±1.93 | 6.03±2.09 5.90 ±2.10 | p=0.676 p=0.529 |
| Statistical significance before treatment vs after treatment | p=0.97 | p=0.82 | |
| C Reactive Protein (CRP) [mg/l] before treatment after treatment | 14.99 ± 16.20 11.26±14.31 | 20.66 ± 25.79 8.21±7.68 | p=0.790 p=0.765 |
| Statistical significance before treatment vs after treatment | p=0.52 | p=0.05 |