## 3 Results  
The baseline characteristics of the 16 participants that were compliant with the baseline visit are presented in Table 3. The population has an average age of 59.9 \(\pm\) 1.5 years and there are 11 males and 5 female participants. 94% (15/16) were diabetic, as evidenced by an approximate 2-fold elevation of the mean FBG and an approximate 1.5-fold increase in the mean values for HbA1c. 63% (10/16) of the participants were undergoing dialysis for ESRD. Baseline analysis revealed no significant differences in the mean values of FBG, HbA1c, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol/HDL-cholesterol ratio and the LDL-cholesterol/HDL-cholesterol ratio were observed between the control and those randomized into the CO\({}_{2}\)-treated group. It should be noted that 80% (12/15) of the participants have elevated C-reactive protein levels (Table 3). \begin{table}
\begin{tabular}{c c c c c} \hline \hline
**Individual Characteristic** & **Full Cohort (N = 16)** & **Control (N = 5)** & **CO\({}_{2}\) (N = 11)** & \(p\)**-Value** \\ \hline Age & 59 (58–64) & 58 (53–58) & 63 (58–65) & 0.059 \\ Sex (Female) & 5 (31\%) & 1 (20\%) & 4 (36\%) & 1.000 \\ Diabetes & 15 (94\%) & 4 (80\%) & 11 (100\%) & 0.313 \\ Hemodialysis & 10 (63\%) & 1 (20\%) & 8 (73\%) & 0.106 \\ Peritoneal Dialysis & 1 (6\%) & 1 (20\%) & 0 (0\%) & 0.313 \\ Not on Dialysis & 6 (38\%) & 3 (60\%) & 3 (27\%) & 0.300 \\ McGill Questionnaire—VAS & 7 (4–13) & 5 (0–7) & 8 (4–14) & 0.392 \\ McGill Questionnaire— Pain Intensity & 6 (4–7) & 3 (0–6) & 7 (5–8) & 0.046 \\ C-Reactive Protein & 10.2 (5.8–14.5) & 12.5 (7.0–46.5) & 10.0 (5.8–14.5) & 0.514 \\ FBG & 8.7 (6.5–12.7) & 7.5 (6.3–8.5) & 9.4 (6.5–16.0) & 0.214 \\ HbA1c (\%) & 8.5 (6.5–9.8) & 6.4 (6.3–7.9) & 9.2 (7.3–10.8) & 0.045 \\ Total Cholesterol & 4.1 (2.9–4.4) & 2.7 (2.5–3.7) & 4.2 (3.3–4.5) & 0.116 \\ Triglycerides & 1.1 (0.8–2.4) & 0.9 (0.7–1.5) & 1.4 (0.8–2.4) & 0.214 \\ HDL & 0.9 (0.8–1.0) & 0.9 (0.8–1.1) & 0.9 (0.8–1.0) & 0.688 \\ LDL & 1.9 (1.2–2.5) & 1.2 (1.0–2.2) & 2.1 (1.7–2.5) & 0.258 \\ Total/HDL & 3.6 (2.9–5.0) & 3.2 (2.5–4.5) & 3.9 (2.9–5.0) & 0.671 \\ LDL/HDL & 1.9 (1.5–2.8) & 1.4 (1.0–2.8) & 2.0 (1.7–2.8) & 0.287 \\ TNF\(\alpha\) (pg/mL) & 27.5 (23.2–36.1) & 31.3 (23.7–26.1) & 23.4 (15.4–37.5) & 0.569 \\ VEGF (pg/mL) & 63.2 (51.7–74.0) & 65.8 (18.5–74.0) & 60.6 (51.7–86.1) & 0.909 \\ \hline \hline \end{tabular}
\end{table} 
Table 3: Baseline characteristics, fasting blood glucose, HbA1c, lipid profile and wound/limb characteristics of patients enrolled into the study. Table 3 shows some of the baseline characteristics of the study participants. It was observed that 38% (6/16) patients are below knee amputees (BKA). All patients had at least one foot ulcer. The McGill Questionnaire revealed that the baseline pain intensity scores were significantly higher in the participants randomized into the CO\({}_{2}\) group. It was also noted that the mean value for oxygen saturation at the site of the wound was approximately 42%. ABI was not measurable in the placebo (control) group and in some patients in the CO\({}_{2}\) group, due to non-compressibility of arteries. However, based on the pre- and post- treatment, an increase in the ABI was observed in the CO\({}_{2}\) group (mean values \(\pm\) S.E.M: baseline = 0.84 \(\pm\) 0.08 (n = 80; treatment = 1 month: 0.97 \(\pm\) 0.12 (n = 4)); 2 months: 0.97 \(\pm\) 0.28 (n = 2); 3 months: 0.97 \(\pm\) 0.40 (n = 2) and 4 months: 1.02 \(\pm\) 0.26 (n = 2)). Figure 1a shows the % wound area reduction in control and CO\({}_{2}\) treated groups. It can be seen that the median wound area reduction was greater in the CO\({}_{2}\) treated group in a time-dependent manner as compared to the control group. Similarly, the median wound area was reduced with increasing extent over the time course of the treatment with CO\({}_{2}\)-enriched as compared to control (Figure 1b). These improvements in the CO\({}_{2}\) treated group were associated with a time-dependent increase in the % median oxygenated Hb levels (Figure 2a).