Table 2.

Comparison of primary follow-up outcomes between the intervention and control groups

Outcome	Total	Intervention group	Control group	p value
	(n = 91)	(n = 45)	(n = 46)
Ulcer healing (Primary endpoint)
Events (Healed), n (%)	66 (72.53%)	37 (82.22%)	29 (63.04%)	0.060
Competing events and censoring
Major Amputation, n (%)	9 (9.89%)	4 (8.89%)	5 (10.87%)	1.000
DFU-related death, n (%)	2 (2.20%)	1 (2.22%)	1 (2.17%)	1.000
Non-DFU-related death, n (%)	5 (5.49%)	1 (2.22%)	4 (8.70%)	0.361
Loss to follow-up, n (%)	9 (9.89%)	2 (4.44%)	7 (15.22%)	0.158

Data are n (%). The primary outcome (ulcer healing) was analyzed with the Kaplan-Meier method and compared using the log-rank test (P = 0.600). The P value for the final healing proportion (0.060) was derived from Pearson’s chi-square test. P values for other outcomes (major amputation, DFU-related death and non-DFU-related death, loss to follow-up) were derived from Fisher’s exact test. Patients who underwent major amputation, died, were lost to follow-up, or remained unhealed were censored in the time-to-event analysis

Abbreviations: DFU, Diabetic foot ulcer