Table 1 Fibreglass casts for heel ulcers in diabetes: trial profile

Check inclusion/exclusion criteria

X

X

Information about study

X

Informed consent

X

Patient demographics

X

ABPI

X

Neuropathy

X

Wound size by acetate tracing

X

X

X

X

X

X

X

X

X

X

X

X

X

Digital image after debridement

X

X

X

X

X

X

X

X

X

X

X

X

X

Cast applied if randomised to cast group

X

X

X

X

X

X

X

X

X

X

X

X

Medication log

X

X

X

X

X

X

X

X

X

X

X

X

X

EQ-5D

X

X

X

CWIS

X

X

X

Pain VAS

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Non-blinded Assessment

X

X

X

X

X

X

X

X

X

X

X

Collect health economic diary

X

X

X

X

X

X

X

X

X

X

X

X

X

Blinded assessment

X

X

Visit at which ulcer is judged healed

2 weeks after ulcer first judged healed

4 weeks after ulcer first judged healed

Visit 7 Week 12

Visit 13 Week 24

Digital image after debridement

X

X

X

X

X

Cast applied if randomised to cast group

X

X

X

X

X

Medication log

X

X

X

X

X

EQ-5D

X

X

CWIS

X

X

Pain VAS

X

X

X

X

X

Non-blinded assessment

X

X

X

X

X

Collect health economic diary

X

X

X

X

X

Blinded assessment

X

X

X

X