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Is combined physical therapy more effective than topical hyperbaric oxygen therapy in the treatment of venous leg ulcers? Preliminary study

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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 treatmentafter treatment 4.22±1.283.39 ± 0.68 4.05±1.363.5 ± 0.71 p=0.708p=0.569
Statistical significancebefore treatment vs after treatment p=0.01 p<0.001
Kaolin-cephalintime (aPTT)[s]before treatmentafter treatment 33.76±9.7737.19 ± 11.97 31.85±9.4231.4 ± 10.17 p=0.554p=0.130
Statistical significancebefore treatment vs after treatment p=0.16 p=0.45
Prothrombin time[s]before treatmentafter treatment 11.75±0.9011.75 ± 0.90 11.80±1.1012.0 ± 0.60 p=0.704p=0.287
Statistical significancebefore treatment vs after treatment p=0.19 p=0.29
International Normalized Ratio (INR)before treatmentafter treatment 1.15±0.251.20 ± 0.20 1.10±0.151.21 ± 0.12 p=0.751p=0.282
Statistical significancebefore treatment vs after treatment p=0.20 p=0.35

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 treatmentafter treatment 105.45 ±7.5591.50±9.45 101.60± 12.55100.1± 12.43 p=0.880p=0.067
Statistical significancebefore treatment vs after treatment p=0.04 p=0.08
Total cholesterol[mg/dl]before treatmentafter treatment 140.83±33.31134.39±34.40 146.33±38.82138.5±27.58 p=0.842p=0.695
Statistical significancebefore treatment vs after treatment p=0.59 p=0.04
Cholesterol-LDL[mg/dl]before treatmentafter treatment 85.78±33.3581.33±33.19 107.56±31.4184.2±25.10 p=0.052p=0.770
Statistical significancebefore treatment vs after treatment p=0.68 p=0.06
Cholesterol-HDL[mg/dl]before treatmentafter treatment 45.89±9.9741.22±9.53 51.26±12.4243.6±8.22 p=0.162p=0.424
Statistical significancebefore treatment vs after treatment p=0.22 p=0.03
Triglycerides [mg/dl]before treatmentafter treatment 107.72±32.09117.44±39.83 119.06±55.01114.6±39.13 p=0.455p=0.831
Statistical significancebefore treatment vs after treatment p=0.50 p=0.80
Total protein[g/dl]before treatmentafter treatment 7.22±0.606.69±0.46 7.00±0.716.60 ±0.65 p=0.319p=0.585
Statistical significancebefore treatment vs after treatment p=0.01 p=0.01
Sodium [mmol/l]before treatmentafter treatment 139.44±2.57137.89±4.59 138.94±3.02139.8±3.45 p=0.596p=0.160
Statistical significancebefore treatment vs after treatment p=0.24 p=0.69
Potassium [mmol/l] before treatmentafter treatment 4.83±0.534.64±0.55 4.58±0.504.40 ±0.38 p=0.149p=0.122
Statistical significancebefore treatment vs after treatment p=0.23 p=0.09
Creatinine [mg/dl]before treatmentafter treatment 0.93±1.940.88±0.15 0.96±0.131.00 ±0.16 p=0.776p=0.281
Statistical significancebefore treatment vs after treatment p=0.82 p=0.74
Urea [mg/dl]before treatmentafter treatment 43.45±11.145.55±15.04 34.85±12.4038.90 ±5.42 p=0.704p=0.248
Statistical significancebefore treatment vs after treatment p=0.46 p=0.70
Uricacid [mg/dl]before treatmentafter treatment 6.28±1.296.29±1.93 6.03±2.095.90 ±2.10 p=0.676p=0.529
Statistical significancebefore treatment vs after treatment p=0.97 p=0.82
C Reactive Protein (CRP) [mg/l]before treatmentafter treatment 14.99 ± 16.2011.26±14.31 20.66 ± 25.798.21±7.68 p=0.790p=0.765
Statistical significancebefore treatment vs after treatment p=0.52 p=0.05

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

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

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 treatmentafter treatment 8.02±2.636.81±2.15 8.30±2.337.26±1.56 p=0.709p=0.484
Statistical significancebefore treatment vs after treatment p=0.35 p=0.01
Erythrocytes [T/l] before treatmentafter treatment 4.28±0.654.13±0.70 4.40±0.544.17±0.49 p=0.660p=0.846
Statistical significancebefore treatment vs after treatment p=0.23 p=0.21
Hemoglobin [g/dl] before treatmentafter treatment 12.22 ± 1.7911.82 ± 1.96 12.70 ± 1.5912.10 ± 1.87 p=0.425p=0.666
Statistical significancebefore treatment vs after treatment p=0.08 p=0.22
Haematocrit [%]before treatmentafter treatment 37.71 ± 5.4036.81 ± 6.07 39.70 ± 5.0737.38 ± 5.65 p=0.259p=0.769
Statistical significancebefore treatment vs after treatment p=0.52 p=0.19
MCV [fl]before treatmentafter treatment 88.57 ± 6.8989.37 ± 5.75 91.10 ± 5.0189.43 ± 6.75 p=0.222p=0.977
Statistical significancebefore treatment vs after treatment p=0.53 p=0.72
MCH [pg]before treatmentafter treatment 28.78 ± 3.0228.69 ± 1.85 29.10 ± 2.0029.97 ± 2.71 p=0.698p=0.722
Statistical significancebefore treatment vs after treatment p=0.63 p=0.80
MCHC [g/dl]before treatmentafter treatment 32.44 ± 1.1632.13 ± 1.14 32.00 ± 1.3932.36 ± 1.14 p=0.264p=0.561
Statistical significancebefore treatment vs after treatment p=0.63 p=0.87
RDW-CV [%]before treatmentafter treatment 13.77 ± 1.6513.56 ± 1.29 13.70 ± 1.5313.51 ± 1.85 p=0.942p=0.926
Statistical significancebefore treatment vs after treatment p=0.90 p=0.36
Platelets [tys./µl] before treatmentafter treatment 271.3 ± 157.7248.6 ± 208.2 248.9 ± 75.8229.5 ± 67.9 p=0.591p=0.713
Statistical significancebefore treatment vs after treatment p=0.39 p=0.54
MPV [fl]before treatmentafter treatment 6.75 ± 1.296.86 ± 1.23 7.00 ± 0.916.72 ± 0.86 p=0.434p=0.685
Statistical significancebefore treatment vs after treatment p=0.61 p=0.66
Neutrophils [%]before treatmentafter treatment 67.11 ± 8.0158.88 ± 10.26 63.10 ± 10.3256.64 ± 9.86 p=0.199p=0.509
Statistical significancebefore treatment vs after treatment p=0.73 p=0.01
Lymphocytes [%]before treatmentafter treatment 21.81 ± 6.5026.24 ± 9.95 25.90 ± 9.7231.02 ± 9.75 p=0.150p=0.155
Statistical significancebefore treatment vs after treatment p=0.79 p=0.05
Monocytes [%]before treatmentafter treatment 7.73 ± 2.198.47 ± 2.68 7.00 ± 2.057.71 ± 1.97 p=0.289p=0.083
Statistical significancebefore treatment vs after treatment p=0.01 p=0.01
Eosinophils [%]before treatmentafter treatment 2.51 ± 3.344.26 ± 2.65 3.30 ± 2.393.77 ± 1.79 p=0.427p=0.516
Statistical significancebefore treatment vs after treatment p=0.15 p=0.01
Basophils [%]before treatmentafter treatment 0.70 ± 0.150.96 ± 0.35 0.80 ± 0.200.87 ± 0.24 p=0.346p=0.364
Statistical significancebefore treatment vs after treatment p=0.58 p=0.43
eISSN:
1732-2693
Lingua:
Inglese
Frequenza di pubblicazione:
Volume Open
Argomenti della rivista:
Life Sciences, Molecular Biology, Microbiology and Virology, Medicine, Basic Medical Science, Immunology