**3. Results**

Over the course of 5 years at our tertiary referral leg ulcer clinic, 1460 patients were diagnosed of chronic venous ulcers (**Figure 1**). Following application of the inclusion and exclusion criteria, 431 patients were enrolled in this study, but only 148 patients were eligible. One hundred and thirty-two patients consented to join the study, of which 67 limbs with 67 ulcers were treated using TWO2 therapy, and 65 limbs with 65 ulcers were treated with CCD. Fiftyseven percent of the patients treated with TWO2 were males (*n* = 38), and 54% of the patients treated with CCD were males (*n* = 35). Risk factors, such as age, gender, the presence of diabetes mellitus, smoking, hypertension and MRSA, were similar, with no statistical significance between each group. There was no significant difference between both the groups in the anatomical distribution of ulcers, size of the ulcers or the duration of the ulcer.

**Figure 1.** Patient with a chronic venous leg ulcer prior to therapy.

Twenty‐four patients (36%) in the TWO2 group and 19 patients (28%) in the CCD group were MRSA positive. Following treatment, MRSA was eliminated in 11 patients (46%), while zero cases of MRSA were eliminated in the CCD group.

The proportion of ulcers completely healed by 12 weeks was 76% (*n* = 51/67) in patients managed with TWO2 compared to 46% (*n* = 30/65) in patients managed with CCD (*P* < 0.0001). The mean reduction in ulcer surface area at 12 weeks was 96% in the TWO2 therapy group (**Figure 2**) compared to 61% in patients managed with CCD. The median time to full ulcer healing was 57 days in the TWO2 group in contrast to 107 days in patients managed with CCD (*P* < 0.0001). Healing time for patients managed with TWO2 was not affected by the extent of time of the ulcer and its size. In fact, ulcers managed with TWO2 had a considerably shorter healing time, when compared to CCD ulcers, regardless of duration (*P* < 0.0001) or ulcer size (*P* < 0.0001). TWO2 patients had a significantly improved Q‐TWiST compared to CCD patients, denoting an improved outcome (*p* < 0.0001).

**Figure 2.** Significant healing and decrease in ulcer surface area post 9 weeks of TWO2 therapy.

In all, three of the patients managed with TWO2 were referred to our facility for primary amputation following the failure of other treatment modalities, including skin grafting. These three ulcers fully healed with no need for amputation in any case. After 36 months of follow‐ up, 14 of the 30 healed CCD ulcers showed recurrence compared to three of the 51 TWO2‐ healed ulcers. Two CCD‐managed ulcers that had not completely healed showed signs of deterioration and increase in surface area (*P* < 0.0001). All the cases that healed with TWO2 showed reversed gradient healing phenomena where the ulcer healed from the centre to the periphery. This might be the reason for the absence of scarring and recurrence.
