Table 1 Characteristics of Included Cohort Studies

Ababneh et al. [28]

Jordan

N = 57

M n = 45

F n = 12

Mean age 56 (SD 10)

Forefoot or midfoot plantar DFU

To investigate levels and factors/ psychosocial factors, associated with adherence to RCW

RCW

i) Wrist band activity monitor (Fitbit Flex)

ii) Boot worn activity monitor

Data downloaded after 7 days.

1 week

Total steps/day

Activity units = correlated at least 50% of time

Device adherence

Activity

Total median 2758 (IQR 1729–4726) daily steps

RCW device worn 34% (SD 17%) of total weight-bearing activity.

Ulcer healing

Not reported

Armstrong et al. [25]

USA

N = 20

M n = 14

F n = 6

Mean age 65 (SD 7.6)

Non-infected, non-ischaemic superficial Texas grade 1A.

To evaluate activity and adherence to RCW

RCW

i) Waist worn accelerometer/pedometer (Biotrainer Pro; IM Systems, Boston, MA).

ii) Boot-worn accelerometer /pedometer (Biotrainer Pro; IM Systems, Boston, MA).

Data recorded 24 hours/day

1 week

Total activity (steps/day).

‘Active use’ = correlated between devices.

Device adherence

Activity

Total mean 1219 (SD 821) steps/ day.

RCW off 873.7 (SD 828) RCW on 345.3 (SD 219); p = 0.01

28% of total daily activity

occurred while RCW worn.

Ulcer healing

Not reported

Saltzman et al. [26]

USA

N = 40

M n = 25

F n = 15

Median age 52

Active Wagner Grade I plantar DFU

To evaluate compliance with recommended non-weight-bearing and rate of ulcer healing

TCC

StepWatch monitor (Cyma, Seattle, Washington) incorporated into TCC.

Data capture during device change every 1 to 2 weeks

13 weeks

Steps per 24, 48 hours and over remaining 13 weeks.

Ulcer healing by 13 weeks

Activity

24 hours: median 523 steps

48 hours: median

808 steps

Median 2083 steps over remaining weeks

Ulcer healing

32/40 (80%) healed (median 6 weeks)

Crews et al. [27]

USA/UK

N = 79 with adherence data from larger cohort of n = 118

N = 46 UK

N = 33 USA

M n = 66

F n = 13

Mean age 56.5 (9.6)

Texas grade 1A up to 2D

To assess association between off-loading adherence and DFU healing (Secondary analysis)

RCW n = 61

Sandal n = 13

Other n = 5

i) Waist worn activity monitor (Lifecorder Plus, Suzuken)

ii) Lifecoder Plus (Suzuken) device concealed in off-loading device.

Data uploaded by clinician. Adherence = boot device correlated > 50% of waist device activity.

6 weeks

Physical activity (hours/day)

Change in ulcer area; Device adherence (days);

Not reported

Hospital Anxiety Depression Scale; NeuroQOL;

IPQ-R.

Activity

Mean hours/day active 6.7 (SD 3.8)

Device adherence mean 35 (SD 10) days or 59% of time active.

Ulcer Healing

19/79 (24%)

Mean ulcer size reduction 230 mm² to 106mm²; p = 0.001.