Offloading the peak plantar pressure in Diabetic patients with loss of protective sensation by using the self-adjusting insoles and individually optimized rocker profiles. The secondary objective is to evaluate the effect of the self-adjusting…
ID
Source
Brief title
Condition
- Diabetic complications
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- In-shoe plantar pressures, measured with a pressure insole (Pedar-X):
1. Peak Pressures (PP)
2. Pressure Time Integral (PTI)
- Balance with and without perturbations, measured with clinical tests and the
force plate treadmill (and Vicon system) of the GRAIL lab of the Center for
Rehabilitation of the UMCG, Beatrixoord:
1. Time taken to stand up-walk- and sit (TUG)
2. Root Mean Square (RMS) of net anterior-posterior (AP) & medio-lateral (ML)
direction during eyes open and closed condition (static balance)
3. Margins of stability during normal gait, AP & ML perturbations (dynamic
balance)
Secondary outcome
kinetics and kinematics of the lower extremity
Background summary
Up to 25% of all patients with diabetes will develop a diabetic foot ulcer.
These ulcers can eventually result in (partial) amputation of
the affected limb. The UMCG developed two products (an individually optimized
rocker profile and a self-adjusting insole) that help prevent ulcerations by
reducing peak pressures. Although the first measurements of the products showed
reduction of peak pressures in diabetic patients, we can*t generalize the
results. The number of included patients was too low (n=4) and also the rocker
shoes were slightly different from the rocker shoes in this study (the rocker
shoes in this study have 1 optimal setting, that is chosen out of a lot of
different settings to offload the peak pressure vs. the adjustable rocker shoes
that have limited amount of settings). Therefore, this study is needed to
continue the development of both products, and to further improve offloading of
the diabetic foot.
Study objective
Offloading the peak plantar pressure in Diabetic patients with loss of
protective sensation by using the self-adjusting insoles and individually
optimized rocker profiles. The secondary objective is to evaluate the effect of
the self-adjusting insoles and individually optimized rocker profiles on
balance.
Study design
Pre-Posttest design
Intervention
1) Unadapted reference shoe (Dr.Comfort, Mequon, WI, USA) + standard insole
(visit 1)
2) Unadapted reference shoe + self-adjusting insole (visit 2)
3) Rocker shoe + standard insole (visit 2)
4) Rocker shoe + self-adjusting insole (visit 2)
5) Rocker shoe + self-adjusting insole (slightly changed version) (visit 3)
6) Unadapted reference shoe + self-adjusting insole (slightly changed version)
(visit 3)
Study burden and risks
No added risks compared to walking with current footwear.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
For the Diabetic patients:
Adult
Diabetes mellitus (type I or II)
Loss of protective sensation (10 gr filament & 128Hz tunning fork)
Ambulatory without use of walking aids (with the exception of the use of
orthopaedic footwear)
Shoe size between 36 and 46
For the healthy reference group:
Ambulatory without use of walking aids
Age between 40-70 year
Shoe size between 36-46
Exclusion criteria
For the Diabetic patients:
Current ulcer(s) and ulcer(s) in the past
Use of walking aids (with the exception of the use of orthopaedic footwear)
Extreme foot deformations (e.g. Charcot foot) or toe or foot amputations that
do not allow participants to fit semi-ready-to-wear shoes
Body weight >130kg
For the healthy reference group:
Use of walking aids
Foot complications (injuries that can influence gait) that do not allow
participants to fit ready-to-wear shoes
Body weight >130kg
Any self-reported injury or disease that affects walking ability
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 | NL76273.042.20 |