Prevention Of Primary Foot Ulcers in High-risk Diabetes Patients (PROFOUND)
Diabetes Mellitus, Foot Ulcer, Diabetic, Primary Prevention
About this trial
This is an interventional prevention trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of diabetes (type 1 or 2)
- Aged ≥18
- Peripheral sensory neuropathy assessed by 10-gram monofilament With
- Signs of abnormal loading as indicated by callus formation or hyperaemia Or
- limb ischaemia as evidenced by intermittent claudication /non-palpable pulses / history of vascular intervention Or
- on renal replacement therapy
Exclusion Criteria:
- Patients currently prescribed with or in need of therapeutic footwear
- Active or history of foot ulcer
- Active Charcot's neuroarthropathy
- History of major operation in the foot including amputation,
- Local / systemic symptoms of infection, severe illness that would make 12 month survival unlikely
- Unable to provide informed consent
- Inability to follow the study instructions (as judged by the recruiting clinician).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Intervention arm
Control
6 sites out of a total of 12 will act as the intervention sites. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to be provided with bespoke 3-D printed insoles.
6 sites out of a total of 12 will act as the control sites providing standard care. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to standard care