Table 2 Characteristics of included randomised controlled studies

Armstrong et al. [21]

USA/UK

N = 63

M n = 52

F n = 11

Age – NR

Neuropathic Texas grade 1A plantar DFU

To compare effectiveness of TCCs, RCWs and half-shoes on neuropathic DFU healing

Total contact cast (TCC) n = 19

vs

RCW n = 20

vs

Half-shoes n = 24

Pedometer (Sportline, Campbell, CA); location not specified

Data recorded by study personnel at weekly visits

12 weeks

Total steps

Ulcer healed (Y/N)

Time to healing

Ulcer area

Activity

Daily steps

TCC: 600 (SD 320)

Half shoe: 1462 (SD 1452) p = 0.04

RCW: data not reported.

Mean difference (SD) TCC vs RCW = 768 (SD 563); p = 0.67

Mean difference (SD) not reported for

RCW vs. Half shoe; p = 0.15.

Ulcer healing:

TCC 90%, RCW 65%

Half shoe 58%, Other data reported graphically.

TCC 90% vs RCW + Half shoe combined 61%; p = 0.03.

Lavery et al. [22]

USA

N = 73

M n = 37

F n = 36

Age – NR

Texas grade 1A/2A plantar DFU

To evaluate efficacy of TCC, healing sandals and removable boot with shear-reducing walker on DFU healing.

Healing Sandals n = 23

vs

TCC n = 23

Vs

Shear-reducing walker n = 27

Waist worn pedometer; brand not reported.

Daily count recorded in activity book at night.

12 weeks

Total steps

Ulcer healing;

Time to healing;

Ulcer area;

Device adherence (% time each day); Satisfaction with foot care and device; Device comfort;

Sleep activity;

Likely to wear device again

Activity

Mean (SD) steps/day

TCC 1447 (SD 1310)

HS 4022 (SD 4652)

SRW 1404 (SD 1234)

HS vs TCC; p = 0.01

HS vs SRW; p = 0.007

Ulcer healing

HS 10/23 (44%)

TCC 16/23 (70%)

SRW 6/27 (22%)

Time to healing (weeks)

HS 8.9 (SD 3.5)

TCC 5.4 (SD 2.9)

SRW 6.7 (SD 4.3)

HS vs TCC p < 0.001

SRW vs TCC p = 0.22

Najafi et al. [23]

USA/Qatar

N = 49

M n = 45

F n = 4

Mean age 53.7

Non-infected, non-ischaemic plantar neuropathic DFU

To report patterns of physical activity as a function of removable and irremovable offloading modality in people with DFU

RCW n = 26

vs

Instant TCC n = 23

Wearable sensor (PAMSys™, BioSensics LLC, MA, USA) incorporated in a shirt (PAMShirt™).

Worn for 48 hours at baseline and once weekly for 48 hours until 12 weeks.

12 weeks

Posture (sitting, standing, lying, walking) as % of total activity;

Number of steps;

Episodes walking;

Gait speed; longest unbroken episode of steps; postural transitions per day (sit-to-stand/ stand-to-sit)

Ulcer healing

Ulcer area

Time to healing

Assessed weekly

HbA1C

Activity

N steps/day at 4 weeks

TCC 2994 (SD 2551)

RCW 5902 (SD 3090); p = 0.07% time walking:

TCC 2.4% (SD 2.1)

RCW 4.8% (SD 2.1)

p = 0.05

Ulcer healing

TCC 16/23 (70%)

RCW 10/26 (40%)

p = 0.05)

Bus et al [24]

Netherlands/Germany

N = 60

M n = 48

F n = 12

Mean age range 61–64 years

Texas grade 1A/2A ulcer

To assess efficacy of three removable devices on offload and heal neuropathic plantar foot ulcers.

Bivalved TCC (n = 20),

Cast Shoe (n = 20)

Forefoot-Offloading Shoe (FOS) (n = 20)

Every second patient fitted ankle worn monitor on contralateral limb for 7 days (StepWatch™, Orthocare Innovations LLC, Oklahoma USA).

20 weeks

Daily strides calculated using manufacturer software

Ulcer healing; Time to healing; Ulcer area; Device adherence (< 50% of time worn).

Assessed every 2 weeks

Activity

Mean (SD) strides/day

TCC: 4150 (SD 1626)

Cast Shoe: 3514 (SD 1380)

FOS: 4447 (SD 3190)

p = 0.71

Device non-adherence

TCC = 17%; Cast Shoe = 5%; FOS = 5%; p = 0.27.

Ulcer healing

TCC: 11/19 (58%)

Cast shoe: 12/20 (60%)

FOS: 14/17 (70%)

p = 0.70