To assess the efficacy of different top covers of inlays worn in orthopaedic footwear on the plantar pressure and patient 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
In-vivo durability of insole top layer material
Background summary
Different orthopedic footwear insole concepts have been developed over the last
years with the goal to unload the plantar foot of diabetic patients with
peripheral neuropathy who require special footwear to protect the foot against
ulceration. Being different in using various material properties of the top
cover of the insole, these insole 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 top covers of inlays worn in orthopaedic
footwear on the plantar pressure and patient satisfaction in diabetic patients
at risk for foot ulceration.
Study design
Cross-sectional and interventional study design
Intervention
The patients left and right insole will be covered with two different and
randomly assigned insole top covers that were tested, and wear these for
approximately 4 weeks. This will be repeated with two other top covers, that
will also be worn for 4 weeks.
Study burden and risks
The risks associated with this study are low. All insole concepts are commonly
used in clinical practice for diabetic patients. There is no known risk of
in-shoe plantar pressure measurements. Patients will be measured on 3
occasions, participating in total 3 hours for the study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
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
- 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 | NL68629.018.19 |