None listed
Conditions
Brief summary
Foot orthoses customised to an individual have been shown to reduce foot pressure loading, foot ulceration and major amputations in patients with diabetes. However, there is limited evidence of treatment for foot pain in patients with diabetes and peripheral arterial disease at risk of foot ulceration and amputation. In particular, evidence for foot orthoses, which are commonly prescribed for this clinical condition, is lacking and there is an urgent need to evaluate their effect on foot pain, comfort, plantar pressure and health-related quality of life. Indeed, if foot orthoses provide an improved level of patient pain/comfort, the patient is more likely to adhere to prescribed daily levels of walking for exercise therefore improving mobility, function and long term peripheral arterial flow which is critical for patient survival.
Interventions
This study will be conducted to investigate the effectiveness of custom-made foot orthoses (shoe innersoles) on foot pain, plantar pressure loading, functional ability and health related quality of life in people with diabetes mellitus and peripheral arterial disease. Participants will be randomly allocated to either an intervention group (custom foot orthoses/footwear) or a control group. All participants are required to wear there allocated device for 8 weeks.
Sponsors
Podiatry Department, Westmead Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects diagnosed with diabetes mellitus and peripheral arterial disease and ambulent foot pain.
Exclusion criteria
wheelchair-bound; foot infection; current foot ulceration; amputation; pregnancy; recent foot trauma; current usage of prescribed foot orthoses; unwilling to wear supplied footwear, or lack of willingness to return for follow-up.
Outcome results
None listed