MetatarsalgiaNCT02667990
Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos
A study testing orthopaedic stilettoe, standard stiletto and comfy trainer in people with Metatarsalgia, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer. Testing involves pedobar pressures and a validated comfort questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 67 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metatarsalgia
- What is being tested?
- orthopaedic stilettoe, standard stiletto and comfy trainer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Jan 2016
- 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 18 to 67 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Foot healthy females used to wearing stilettos.
Who cannot join
- Shoe sized outside European 37-42.
- Sought doctor for foot or balance related issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maximal Plantar Pressure and Comfort Evaluation During Normal Every Day Use of an "Orthopedic" Stiletto, a Normal Stiletto and a Control Trainer Shoe
22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer.
Testing involves pedobar pressures and a validated comfort questionnaire.
Read the detailed description
22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer testing involved pedobar pressures and a validated comfort questionnaire.
x rays with arthrosis 1. metatarsophalangeal joint (MTPJ), hallux valgus and Intermetatarsal (IM) angles will be recorded.
Clinically, weight, height, foot length, heel valgus, 1. MTPJ range of motion, pain, callus, hammertoes will be recorded.
Sole pressure in heel, arch and forefoot grids measured by in-sole pressure pedar-x (Novel) and possible Emed system (Novel).
3 working days in each type of shoe with Steps measured by pedometer Comfort assed as VAS according to: Mundermann,A., Nigg,B.M., Stefanyshyn,D.J., and Humble,R.N.: Development of a reliable method to asses footwear comfort during running. Gait Posture, 16:38-45, 2002.
Primary outcome is the foot sole pressures. Both VAS comfort and foot pressures will be regressed to see if age, BMI, shoe size, steps, shoe type, callus, index minus, hallux valgus etc has an effect.
16 needed for the pressure and 21 for the comfort score. 22 will be included to make sure the investigators have enough power.
- Conditions
- Metatarsalgia
- Being tested
- orthopaedic stilettoe, standard stiletto, comfy trainer
- Keywords
- metatarsalgia, pedobar, foot, stiletto, insoles
- Medical subject headings
- Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthopaedic stilettoeOther
stilettos with orthopaedic in-sole buildt into the shoe
standard stilettoOther
standard stiletto without insole
comfy trainerOther
comfy trainer
| Study group | Role | What they receive |
|---|---|---|
| orthopaedic stilettoe | Experimental | orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer Receives: Other: orthopaedic stilettoe; Other: standard stiletto; Other: comfy trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
plantar foot pressure
Mean and peak pressure and pressure/time in the heel, arch and fore foot ( fore foot subdivided into 1. metatarsal head, 2+3 rd head, 4+5th head and the big toe). Pressure measured as Newton/sq. cm.
Measured: 1 hrs
Secondary outcomes (1)
comfort rating footwear
VAS scale indication comfort around the shoe. The scale is continuous from 0 to 15, with 15 being the most comfortable condition imaginable. It measures: Overall comfort, Heel cushioning, Forefoot cushioning, Arch height, Heel cup fit, Heel cup width, Shoe forefoot width, Shoe length. The investigators will register all but the overall comfort and the cushioning measures are assumed the most interesting measures in this study. (Mundermann,A., Nigg,B.M., Stefanyshyn,D.J., and Humble,R.N.: Development of a reliable method to assess footwear comfort during running. Gait Posture, 16:38-45, 2002.)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetatarsalgiaStudies 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeannette Penny, Copenhagen University Hospital, Hvidovre
- Investigators
- jeannette penny, PhD, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667990
- Sponsor's protocol ID
- 47798
- Status last verified
- Jan 2016
- First submitted
- 28 Aug 2015
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Plantar Pressure and Comfort Evaluation During Normal Every Day Use of an "Orthopedic" Stiletto, a Normal Stiletto and a Control Trainer Shoe
- ClinicalTrials.gov ID
- NCT02667990
- Acronym / sponsor ID
- 47798
- Conditions
- Metatarsalgia
- Keywords
- metatarsalgia, pedobar, foot, stiletto, insoles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Jan 2016 (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.
22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer.
Testing involves pedobar pressures and a validated comfort questionnaire.
Detailed description
22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer testing involved pedobar pressures and a validated comfort questionnaire.
x rays with arthrosis 1. metatarsophalangeal joint (MTPJ), hallux valgus and Intermetatarsal (IM) angles will be recorded.
Clinically, weight, height, foot length, heel valgus, 1. MTPJ range of motion, pain, callus, hammertoes will be recorded.
Sole pressure in heel, arch and forefoot grids measured by in-sole pressure pedar-x (Novel) and possible Emed system (Novel).
3 working days in each type of shoe with Steps measured by pedometer Comfort assed as VAS according to: Mundermann,A., Nigg,B.M., Stefanyshyn,D.J., and Humble,R.N.: Development of a reliable method to asses footwear comfort during running. Gait Posture, 16:38-45, 2002.
Primary outcome is the foot sole pressures. Both VAS comfort and foot pressures will be regressed to see if age, BMI, shoe size, steps, shoe type, callus, index minus, hallux valgus etc has an effect.
16 needed for the pressure and 21 for the comfort score. 22 will be included to make sure the investigators have enough power.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| orthopaedic stilettoe | Experimental | Other: orthopaedic stilettoe, Other: standard stiletto, Other: comfy trainerorthopaedic stilettoe will be compared to standard stilettoe and comfy trainer |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Foot healthy females used to wearing stilettos.
Key exclusion criteria (2 listed)
- Shoe sized outside European 37-42.
- Sought doctor for foot or balance related issues
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 |
|---|---|---|
| orthopaedic stilettoestilettos with orthopaedic in-sole buildt into the shoe | Other | orthopaedic stilettoe |
| standard stilettostandard stiletto without insole | Other | orthopaedic stilettoe |
| comfy trainercomfy trainer | Other | orthopaedic stilettoe |
Primary outcome
plantar foot pressure
Time frame: 1 hrs
Mean and peak pressure and pressure/time in the heel, arch and fore foot ( fore foot subdivided into 1. metatarsal head, 2+3 rd head, 4+5th head and the big toe). Pressure measured as Newton/sq. cm.
1 secondary outcome
comfort rating footwear
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
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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.
jeannette penny, PhD principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthopaedic stilettoe, standard stiletto and comfy trainer in people with Metatarsalgia, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plantar foot pressure (time frame: 1 hrs). 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 29 Jan 2016.