Research with human participants

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Combination of an adjustable rocker profile and a self-adjusting insole in patients with Diabetes

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Last updated:

Evaluate the effect of the adjustable rocker, the self-adjusting insole, and a combination of both on in-shoe plantar peak pressures in patients with diabetes related neuropathy.

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Diabetic complications
Study type
Interventional

ID

NL-OMON50239

Source

ToetsingOnline

Brief title

Combination: adjustable rocker and self-adjusting insole

Condition

  • Diabetic complications
  • Peripheral neuropathies

Synonym

piekdruk, plantiare voetdruk

Research involving

Human

Sponsors and support

Primary sponsor :
Universitair Medisch Centrum Groningen
Source(s) of monetary or material Support :
NWO;Symbionics program;Dynamic Ulcer Prevention Insole

Intervention

Keyword :
diabetes, foot ulcers, individual, prevention

Outcome measures

Primary outcome

Peak Pressure

Secondary outcome

Max Mean Pressure

Force time integral

VAS-score for comfort

Spatio-temporal parameters; stepfrequency, steplength, stepwidth

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 (adjustable rocker and self-adjusting
insole) that help prevent ulcerations by reducing peak pressures. First test in
healthy subjects showed reduction in peak pressures. However, these results can
not be directly translated to the patientgroup.

Study objective

Evaluate the effect of the adjustable rocker, the self-adjusting insole, and a
combination of both on in-shoe plantar peak pressures in patients with diabetes
related neuropathy.

Study design

Intervention with within subject design

Intervention

Walking with adjustable rocker
Walking with self-adjusting insole
Walking with combination of the adjustable rocker and the self-adjusting
insole.

Study burden and risks

No added risks compared to walking with current footwear.

Public
Universitair Medisch Centrum Groningen

Hanzeplein 1
Groningen 9700RB
NL
Scientific
Universitair Medisch Centrum Groningen

Hanzeplein 1
Groningen 9700RB
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Adult
Diabetes mellitus (type I or II)
Neuropathy (10gr filament)
Ambulatory
shoe size between 36 -45

Exclusion criteria

Current ulcer
Recently healed ulcer (< 2 months)
Use of walking aids
Foot deformations
Charcot foot

Design

Study type :
Interventional
Intervention model
:
Crossover
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Prevention

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
10
Type :
Actual

Medical products/devices used

Generic name :
Adjustable rocker profile and self-adjusting insole
Registration
:
No

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Universitair Medisch Centrum Groningen (Groningen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Universitair Medisch Centrum Groningen (Groningen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Universitair Medisch Centrum Groningen (Groningen)

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 NL65662.042.18
Other NTR 28991