To assess the efficacy of different orthopaedic footwear concepts on the plantar pressure and patients satisfaction in diabetic patients at risk for foot ulceration
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peak plantar pressure
Secondary outcome
Patient satisfaction
Background summary
Different orthopaedic footwear design concepts have been developed over the
last years with the goal to offload the plantar foot of diabetic patients with
peripheral neuropathy who require special footwear to protect the foot against
ulceration. Being fundamentally different in the approach to how the footwear
is designed and evaluated, these footwear concepts may be less or more
effective in offloading the diabetic foot. A comparison between these concepts
in their offloading efficacy has not been performed to date, but can inform us
about what entails effective footwear that may result in the best shoe design
for the diabetic foot patient
Study objective
To assess the efficacy of different orthopaedic footwear concepts on the
plantar pressure and patients satisfaction in diabetic patients at risk for
foot ulceration
Study design
Cross-sectional study design
Study burden and risks
The risks associated with this study are low. All footwear concepts studied
have been part of previous studies and/or are commonly used in clinical
footwear practice for diabetic patients. There is no known risk of in-shoe
plantar pressure measurement. Patients will be measured on 3 occasions,
participating in total 4 hours for the study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Diabetes mellitus
- Peripheral neuropathy
- Diabetic foot risk classification categories 2 and 3 (i.e. presence of peripheral vascular disease or foot deformity, or a history of foot ulceration).
- Possession of or prescription of semi-custom-made or fully custom-made footwear
Exclusion criteria
- Active ulceration
- Inability to walk at least 100m
- Foot deformity that in terms of shoe fit does not allow the use of semi-custom-made footwear (i.e. midfoot Charcot foot, ankle deformity), as judged by the prescribing physician and shoe technician
- Amputation of more than 2 toes (not the hallux)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50344.018.14 |