To what extent does the use of therapeutic footwear, which is prescribed and monitored using plantar pressure distribution assessment, result in a reduced plantar ulcer recurrence rate compared to the use of therapeutic footwear which is prescribed…
ID
Source
Brief title
Condition
- Diabetic complications
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of patients with a recurrent plantar foot ulcer in 18 months
Secondary outcome
- Cost-effectiveness and const-utility of using in-shoe plantar pressure
analysis
- Perceive usability of therapeutic footwear
- Compliance of shoe use
- Daily activity level
Background summary
The diabetic foot ulcer is a major complication in diabetic patients with
neuropathy; about 1 of the 6 patients with diabetes will have a foot ulcer.
Despite the improved health care, ulceration often results in infection and
finally in amputation. Furthermore, foot ulcers often recur. Therefore,
prevention of foot ulceration is an important goal.
Most foot ulcers develop on the plantar surface of the foot. Therapeutic
footwear seems to be essential in preventing this complication. However,
evidence on the effectiveness of therapeutic footwear to prevent recurrent
ulcers is lacking. This may be due to the fact that none of the studies have
used plantar pressure measurements which make it difficult to determine what
the pressure-relieving characteristics of the footwear were and its role on
preventing ulceration.
In current practice, shoes are prescribed based on the experience and expertise
of physician and shoe technician. In-shoe pressure measurements during this
process guarantee a more objective approach, which can result in a better
pressure distribution with an expected lower chance for developing recurrent
plantar ulceration.
Study objective
To what extent does the use of therapeutic footwear, which is prescribed and
monitored using plantar pressure distribution assessment, result in a reduced
plantar ulcer recurrence rate compared to the use of therapeutic footwear which
is prescribed according to current practice
Study design
In a multicenter randomized controlled trial, diabetic patients with a history
of plantar foot ulceration who are prescribed with therapeutic footwear will be
randomized to either a control group or an experimental group. In the control
group footwear will be prescribed and modified based on current practice; in
the experimental group this will be done based on in-shoe plantar pressure
measurements. Both groups will be followed for 18 months. Every 3 months
plantar pressure monitoring will take place. Furthermore, shoe use and daily
activity level will be assessed twice for 4 consecutive days during the study.
Quality of life will be assessed during the study, partly for use in a
cost-effectiveness and cost-utility analysis of using plantar pressure
measurements.
Intervention
The intervention consists of the 3-monthly use of in-shoe pressure analysis for
the optimization of therapeutic footwear in diabetic patients with a prior
plantar foot ulcer.
Study burden and risks
Patients will be asked to visit their hospital/centre for a baseline
assessment, an entry measurement and 6 follow-up measurements. The baseline
assessment will take approximately 80 minutes, all other assessments between 60
and 90 minutes. Additionally, patients will be asked to complete several
questionnaires.
There are no known risks with plantar pressure measurement. Patients who will
develop an ulcer during the study period will be excluded from further pressure
measurements, but will be followed with respect to a cost-effectiveness
analysis.
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. Age >18 and <85 years old
2. Diagnosis of diabetes mellitus Type 1 or 2
3. Loss of protective sensation due to peripheral neuropathy
4. A history of plantar foot ulceration within the last 18 months
5. A new therapeutic footwear prescription (OSA or OSB)
Exclusion criteria
1. Active foot ulceration
2. Amputation proximal to the metatarsal bones in the foot
3. Severe illness that would make 18-months survival unlikely
4. The use of walking aids that contribute to offloading the foot (wheel chair, more than one crutch)
5. Parallel participation in another study that may influence the outcomes of this study.
6. Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study.
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 | NL17525.018.07 |