Table 4.

Study participants with wound closure (wound closure rate) and the number of participants with recurrences (recurrence rate) in the ITT population

Wound closure and recurrence rate in the ITT population	Total n=345	NPWT n=171	SMWC n=174	Difference n % (95%CI) p*
Patients with complete, sustained and confirmed wound closure within 16 weeks
n % (95% CI)	46 of 345 13.3 (9.8–17.8)	25 of 171 14.6 (9.5–21.6)	21 of 174 12.1 (7.5–18.4)	4 2.5 (−4.7 – 9.7) 0.53
Patients with recurrence of the diabetic foot wound after complete, sustained and confirmed closure within 6 months
n % (95% CI)	1 of 46 2.2 (0.1–12.1)	1 of 25 4 (0.1–22.3)	0 of 21 0 (0.0–14.3)	1 4 (−3.7 – 11.7) 1.00

Data show the number (N) of participants available for the analysis in total and for both treatment arms. Wound closures within the maximum study treatment time of 16 weeks and recurrences during the follow-up of 6 months are shown with the number (N), the percentage (%) of patients and the 95% Confidence Interval (CI).

*F=Fishers’ exact test.

ITT, intention to treat; NPWT, negative pressure wound therapy; SMWC, standard moist wound care.