Randomized Controlled Trial to Assess the Efficacy of a Single-use Negative Pressure Wound Therapy System, Compared to Traditional Negative Pressure Wound Therapy in the Management of Venous Leg Ulcers and Diabetic Foot Ulcers

Background: High quality clinical evidence on the management of chronic wounds with Negative Pressure Wound Therapy (NPWT) is still scarce for VLU and DFU.

Purpose: We aimed to assess for non-inferiority the efficacy of a single use NPWT System (s-NPWT) versus traditional NPWT (t-NPWT). 

Methods: Multi-centre, controlled, randomized study in subjects with VLU or DFU to compare the percentage change in target ulcer size (main endpoint: surface area; secondary endpoints: ulcer depth and volume, healing rates, between baseline and end of 12-week treatment period or wound closure. 

Results: Out of 164 randomized subjects, 161 competed at least one visit (ITT population; 101 with VLU, 60 with DFU), of these, 115 completed follow-up without protocol deviations (PP population; 64 with s-NPWT and 51 with t-NPWT). Treatment groups were statistically similar. Wound area analyses (PP) demonstrated statistically significant reduction favouring s-NPWT (p=0.003). ITT data analyses yielded similar results (p<0.001). Similar significant results were obtained for wound depth (p=0.018), and wound volume (p=0.013). Confirmed wound closure was obtained for 36 (45%) subjects in sNPWT versus 18 (22.2%) subjects in t-NPWT (p=0.002). Median estimate of the time to achieve confirmed wound closure was 77 days for s-NPWT. Sixty percent of area reduction took place during the first 4 weeks of treatment in the s-NPWT group. No healing estimates could be provided for t-NPWT.

Conclusion: Assessment of overall satisfaction, willingness to use the device in the future, comfort of use, interference with mobility and impact on sleep showed a statistically significant difference in trend of agreement in favour of s-NPWT.
The s-NPWT system met non-inferiority, and further achieved superiority in terms of wound progression towards healing (reductions in area, depth, and volume) over the 12-week period. Trial provided insights to explain the superiority through the mechanism of action of the s-NPWT.