Diabetes MellitusNCT02061059
Cost-effectiveness of In-shoe Pressure Measurement for Therapeutic Shoes
A study testing block 1, block 2 and standard in people with Diabetes Mellitus and Polyneuropathies, run by Maastricht University at 2 sites in Netherlands.
Trial summary
The purpose of this study is determine whether the use of plantar pressure measurements in the production of customized therapeutic footwear for patients with diabetes and a history of foot ulceration results in lower production costs and more pressure relief, compared to the standard production. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Polyneuropathies
- What is being tested?
- block 1, block 2 and standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNetherlands
- Study dates
- Mar 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diabetes
- neuropathy
- prescription of therapeutic footwear
- diabetic foot ulcer in the last 5 years
- receiving regular preventive foot care
- written informed consent
Who cannot join
- peripheral arterial disease
- not motivated to wear therapeutic footwear
- active foot ulcer
- recent vascular intervention
- severe mobility impairment
- amputation more proximal than toes, except a single ray amputation is allowed.
Show all 14Show fewer
- severe visual impairment
- active cancer
- severe cardiac/ pulmonary failure
- severe oedema
- chronic drug abuse
- severe psychiatric illness
- hospital admission at the time of inclusion
- any condition that may interfere with follow-up visits.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastricht University
Maastricht, 6200MD
Tom Melai, PhD
Smeets Loopcomfort
Sittard, 6135 LE
Tom Melai, PhD
About this study
Official title: Improving the Cost-effectiveness of Therapeutic Shoes for Diabetic Patients With a Previous Foot Ulcer Using an In-shoe Pressure Device
The purpose of this study is determine whether the use of plantar pressure measurements in the production of customized therapeutic footwear for patients with diabetes and a history of foot ulceration results in lower production costs and more pressure relief, compared to the standard production. A secondary objective is to explore if a difference in durability can be observed in pressure reduction and development of (pre-) ulcerative lesions between the shoes produced with and without plantar pressure measurements.
Read the detailed description
For each patient two pairs of shoes will be produced by two shoemakers, one using plantar pressure measurements and one according current standard production procedures. The patient will wear one of these two pairs of shoes during a period of 3 months.
- Conditions
- Diabetes Mellitus, Polyneuropathies
- Being tested
- block 1, block 2, standard, with measurements
- Medical subject headings
- Diabetes Mellitus, Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
block 1Other
shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements
block 2Other
shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
standardOther
patient wears shoes produced with standard method
with measurementsOther
patient wears shoes produced with plantar pressure measurements
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | group is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements.
group is assigned to "standard": wears shoes produced with standard procedure Receives: Other: block 1; Other: standard |
| group 2 | Other | group is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements
group is assigned to "with measurements": wears shoes produced with plantar pressure measurements Receives: Other: block 1; Other: with measurements |
| group 3 | Other | group is assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
group is assigned to "standard": wears shoes produced with standard procedure Receives: Other: block 2; Other: standard |
| group 4 | Other | group assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
group is assigned to "with measurements": wears shoes produced with plantar pressure measurements Receives: Other: block 2; Other: with measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cost-effectiveness of shoes produced with and without plantar pressure measurements.
Measured: approximately 10 weeks (at delivery of the shoes)
Secondary outcomes (6)
Change in plantar pressure after wearing the therapeutic shoes for 3 months.
Measured: approximately 22 weeks (at follow-up)
The number of participants with reported and/ or visible new diabetic foot problems, such as ulcera or pre-ulcerative lesions.
The number of diabetic foot problems serves as an additional measure of the quality of the therapeutic shoes produced.
Measured: approximately 22 weeks (at follow-up)
Differences in production techniques, materials and procedures used by the two shoemakers to produce the two pair of shoes.
Qualitative measure of differences in production process of the shoes produced with or without plantar pressure measurements.
Measured: approximately 10 weeks (at delivery of the shoes)
Differences in plantar pressures between the two shoes produced.
Measured: approximately 10 weeks (at delivery of the shoes)
The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes".
Measured: approximately 22 weeks (at follow-up)
Differences in plantar pressures between the two shoes produced.
Measured: approximately 22 weeks (at follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolaas C Schaper, PhD, MD, Principal investigator, Maastricht University Medical CenterHans H Savelberg, PhD, Study director, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061059
- Sponsor's protocol ID
- 13-1-112.3
- Status last verified
- Feb 2014
- First submitted
- 10 Feb 2014
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Cost-effectiveness of Therapeutic Shoes for Diabetic Patients With a Previous Foot Ulcer Using an In-shoe Pressure Device
- ClinicalTrials.gov ID
- NCT02061059
- Acronym / sponsor ID
- 13-1-112.3
- Conditions
- Diabetes Mellitus, Polyneuropathies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is determine whether the use of plantar pressure measurements in the production of customized therapeutic footwear for patients with diabetes and a history of foot ulceration results in lower production costs and more pressure relief, compared to the standard production. A secondary objective is to explore if a difference in durability can be observed in pressure reduction and development of (pre-) ulcerative lesions between the shoes produced with and without plantar pressure measurements.
Detailed description
For each patient two pairs of shoes will be produced by two shoemakers, one using plantar pressure measurements and one according current standard production procedures. The patient will wear one of these two pairs of shoes during a period of 3 months.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Other: block 1, Other: standardgroup is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements. group is assigned to "standard": wears shoes produced with standard procedure |
| group 2 | Other | Other: block 1, Other: with measurementsgroup is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements group is assigned to "with measurements": wears shoes produced with plantar pressure measurements |
| group 3 | Other | Other: block 2, Other: standardgroup is assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements group is assigned to "standard": wears shoes produced with standard procedure |
| group 4 | Other | Other: block 2, Other: with measurementsgroup assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements group is assigned to "with measurements": wears shoes produced with plantar pressure measurements |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- diabetes
- neuropathy
- prescription of therapeutic footwear
- diabetic foot ulcer in the last 5 years
- receiving regular preventive foot care
Key exclusion criteria (14 listed)
- peripheral arterial disease
- not motivated to wear therapeutic footwear
- active foot ulcer
- recent vascular intervention
- severe mobility impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| block 1shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements | Other | group 1, group 2 |
| block 2shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements | Other | group 3, group 4 |
| standardpatient wears shoes produced with standard method | Other | group 1, group 3 |
| with measurementspatient wears shoes produced with plantar pressure measurements | Other | group 2, group 4 |
Primary outcome
The cost-effectiveness of shoes produced with and without plantar pressure measurements.
Time frame: approximately 10 weeks (at delivery of the shoes)
6 secondary outcomes
Change in plantar pressure after wearing the therapeutic shoes for 3 months.
Time frame: approximately 22 weeks (at follow-up)
The number of participants with reported and/ or visible new diabetic foot problems, such as ulcera or pre-ulcerative lesions.
Time frame: approximately 22 weeks (at follow-up)
Differences in production techniques, materials and procedures used by the two shoemakers to produce the two pair of shoes.
Time frame: approximately 10 weeks (at delivery of the shoes)
Differences in plantar pressures between the two shoes produced.
Time frame: approximately 10 weeks (at delivery of the shoes)
The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes".
Time frame: approximately 22 weeks (at follow-up)
Differences in plantar pressures between the two shoes produced.
Time frame: approximately 22 weeks (at follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolaas C Schaper, PhD, MD principal investigator
Maastricht University Medical Center
Hans H Savelberg, PhD study director
Maastricht University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing block 1, block 2 and standard in people with Diabetes Mellitus and Polyneuropathies, run by Maastricht University at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Melai, PhD (+31 43 3881398, tom.melai@MaastrichtUniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cost-effectiveness of shoes produced with and without plantar pressure measurements. (time frame: approximately 10 weeks (at delivery of the shoes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.