Journal of Diabetes Research

Review Article

Effects of Special Therapeutic Footwear on the Prevention of Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Table 1

Characteristics of included studies.

(a)


Author/year	Country	Prevention target	Group	Number of participants	Age (years)	Male (%)	History of foot ulcer (%)	Intervention time (months)	HbA1c (%)	VPT (V) at baseline	BMI (kg/m²)	Duration of diabetes (years)	Incidence of foot ulcers

Bus et al., [6]	Netherlands	Secondary prevention	Intervention	85		82	100	18					33
Bus et al., [6]	Netherlands	Secondary prevention	Control	86		83	100	18					38

Lavery et al., [27]	USA	Primary and secondary prevention	Intervention	149		69	27.5	18	NR		NR		3
Lavery et al., [27]	USA	Primary and secondary prevention	Control	150		67	25.3	18	NR		NR		10

Reiber et al., [28]	USA	Secondary prevention	Intervention 1	121		78	100	24	NR	NR		NR	18
			Intervention 2	119		77	100	24	NR	NR		NR	17
			Control	160		77	100	24	NR	NR		NR	27

Rizzo et al., [29]	Italy	Primary and secondary prevention	Intervention	148		68	NR	12					17
Rizzo et al., [29]	Italy	Primary and secondary prevention	Control	150		66	NR	12					58

Scire et al., [30]	Italy	Primary prevention	Intervention	89		NR	0	3					1
Scire et al., [30]	Italy	Primary prevention	Control	78		NR	0	3					12

Uccioli et al., [31]	Italy	Secondary prevention	Intervention	33		61	100	12	NR		NR		9
Uccioli et al., [31]	Italy	Secondary prevention	Control	36		64	100	12	NR		NR		21

Cisneros et al., [32]	Brazil	Primary and secondary prevention	Intervention	30		63	26.7	24	NR	NR	NR		8
Cisneros et al., [32]	Brazil	Primary and secondary prevention	Control	23		36	34.8	24	NR	NR	NR		8

Ulbrecht et al., [33]	USA	Secondary prevention	Intervention	66		76	100	15	NR	NR		NR	6
Ulbrecht et al., [33]	USA	Secondary prevention	Control	64		81	100	15	NR	NR		NR	16

(b)


Author/year	Country	Group	Number of participants	Adherence (%)	Insensate to monofilament (%)	Peripheral artery disease (%)	Foot deformity (%)	History of minor amputation (%)

Bus et al., [6]	Netherlands	Intervention	85	41.2	94.1	28.8	95.3	0
Bus et al., [6]	Netherlands	Control	86	51.2	91.9	37.5	97.7	0

Lavery et al., [27]	USA	Intervention	149	4 h/d: 15.5 4-8 h/d: 52.0 8-12 h/d: 25.7 12-16 h/d: 6.8	NR	0	NR	12.1
Lavery et al., [27]	USA	Control	150	4 h/d: 10.6 4-8 h/d: 55.0 8-12 h/d: 30.5 12-16 h/d: 3.9	NR	0	NR	8.7

Reiber et al., [28]	USA	Intervention 1	121	83.0	59	NR	36	0
		Intervention 2	119	86.0	66	NR	22	0
		Control	160	NR	52	NR	35	0

Rizzo et al., [29]	Italy	Intervention	148	NR	NR	NR	NR	NR
Rizzo et al., [29]	Italy	Control	150	NR	NR	NR	NR	NR

Scire et al., [30]	Italy	Intervention	89	NR	NR	0	6	NR
Scire et al., [30]	Italy	Control	78	NR	NR	0	8	NR

Uccioli et al., [31]	Italy	Intervention	33	100	NR	NR	NR	0
Uccioli et al., [31]	Italy	Control	36	NR	NR	NR	NR	0

Cisneros et al., [32]	Brazil	Intervention	30	≤6 h/d: 34.5 >6 h/d: 37.9 Not daily: 27.6	NR	NR	50.0	NR
Cisneros et al., [32]	Brazil	Control	23	NR	NR	NR	30.4	NR

Ulbrecht et al., [33]	USA	Intervention	66	NR	NR	NR	NR	31.8
Ulbrecht et al., [33]	USA	Control	64	NR	NR	NR	NR	37.5

Data are shown as numbers, or %. NR, not reported; BMI, body mass index; VPT, vibration perception threshold; HbA1c, glycosylated hemoglobin. This study had two intervention groups (intervention 1: custom cork-insert group; intervention 2: polyurethane insert group). For the meta-analyses the intervention 1 group and intervention 2 were incorporated into a single intervention group to compare with control group. This study reported only the overall proportions of patients with foot deformities (46%), history of foot ulcer (20%), and history of minor amputation (25%) among all participants.