Table 8.

Summary of studies that examined the safety of treatment interventions for people with diabetes

Study	Design	Subjects	Infection	Organism	Intervention	Assessment (week)
Gupta [42]	RCT	Itraconazole N = 35 Sex = 16 M; 19 F Age = 57.77 (2.3) yr Terbinafine N = 35 Sex = 18 M; 17 F Age = 63.65 (1.9) yr	DLSO	Dermatophyte	Ciclopirox 8% Ciclopirox 8% nail lacquer applied to nail and 5 mm surrounding skin. Daily application over the previous coat, removed after 7 days using isopropyl alcohol. Nails trimmed and debrided at each scheduled visit (8 weeks)	48
Brenner [43]	Case series	N = 49† Sex = 36 M; 13 F Age = 63.8 (12.0) yr Duration of diabetes = 8.4 (7.4) yr Duration of infection = 10.8 (15.3) yr	DSO††	Not reported†	Terbinafine 250 mg terbinafine daily 12 weeks	48
Farkas [46]	Case series	N = 89 Sex = 47 M; 42 F Age = 55.7 (11.7) yr Duration of diabetes = 10.2 (7.7) Duration of infection = 5.4 (6.0)	DSO	Dermatophyte (67.4%); moulds (5.6%); yeast (4.5%)	Itraconazole pulse therapy 200 mg of oral itraconazole taken twice a day for the first week of three consecutive months Terbinafine 250 mg of oral terbinafine once daily for 12 weeks.	48
Sadighha [41]	Case series	N = 13 Sex = NR Age = NR	DSO††	Dermatophyte†	Pulse itraconazole therapy 200 mg of oral itraconazole taken twice a day for the first week of four consecutive months	26

^† Concomitant tinea pedis was present.

"DSO" = distal subungual onychomycosis; "DLSO" = distal lateral subungual onychomycosis

Study 4 is excluded from the graph because efficacy was not assessed at week 48 like the rest of the studies. Sadighha [41] found itraconazole achieved cure in 7.7% (1/13) of patients with diabetes at week 26