Foot PainPhase 1/2NCT05434078
Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear
A Phase 1/2 study testing Orthofeet Shoes in people with Foot Pain, run by Bijan Najafi, PhD at 1 site in United States.
Trial summary
The purpose of this prospective randomized crossover study is to evaluate the effectiveness of a new pain relief footwear, Orthofeet, in reducing foot pain and improving daily physical activity. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Pain
- What is being tested?
- Orthofeet Shoes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 30 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years or older
- self reported foot pain including heel, arch, or ball of foot
Who cannot join
- Plantar ulcer Patients with major foot deformity (e.g., Charcot foot, Pes Cavus)
- Lower extremity amputation including minor amputation. Foot pain because of nail disorder or keratotic lesions (e.g. corns, calluses)
- unstable conditions such as recent stroke, anticipated changes in medication regime
- Acute fractures of the foot
- Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance.
- major cognitive impairment or major depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orthofeet: A Prospective Proof of Concept Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Pain Relief Footwear
The purpose of this prospective randomized crossover study is to evaluate the effectiveness of a new pain relief footwear, Orthofeet, in reducing foot pain and improving daily physical activity. The investigators hypothesize that wearing Orthofeet shoes will lead to a reduction in foot pain, resulting in increased daily physical activity, objectively measured using validated wearable devices.
Read the detailed description
A clinical study at Baylor College of Medicine is being conducted to evaluate the short- and intermediate-term benefits and effectiveness of a novel pain relief footwear, Orthofeet. This 12-week randomized crossover trial aims to recruit 50 eligible ambulatory adults (aged 50 years or older) with moderate self-reported foot pain. Participants will be randomly assigned to Group AB (25 subjects) or Group BA (25 subjects), with no differences in assessments or eligibility criteria between the groups. In Group AB, participants will wear Orthofeet shoes for 6 weeks, followed by their own shoes for another 6 weeks, while Group BA will follow the reverse order. Pain and function, the primary outcomes, will be measured using the Foot Function Index (FFI), and acceptability will be assessed using a Technology Acceptance Model (TAM) questionnaire. Data will be collected at baseline, 6 weeks, and 12 weeks.
- Conditions
- Foot Pain
- Being tested
- Orthofeet Shoes
- Keywords
- foot pain, falls, frailty, footwear, mobility
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthofeet ShoesDevice
Participants will wear a pair of Orthofeet shoes to wear for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group AB | Active comparator | Group AB will be started with 6-week Intervention A (OrthoFeet) and then switched to 6-week intervention B (own shoes) Receives: Device: Orthofeet Shoes |
| Group BA | No intervention | Group BA will be started with B (own shoes) for 6 weeks and then switched to Intervention A (OrthoFeet) for the same duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Pain at Its Worst at Baseline and Week 6
Changes in foot pain from baseline to 6 weeks for each intervention (Orthofeet and own shoes) will be assessed using the Foot Function Index (FFI) questionnaire. The FFI consists of four overall scores, including three subscales: 1) Pain Score (the primary outcome in this study), 2) Disability Score, 3) Activity Limitation Score, and 4) Overall Score.
The Pain subscale asks participants to rate their foot pain on a scale of 0 (no pain) to 10 (worst imaginable pain), based on their experiences during various activities over the past two weeks. For this outcome, we focused on the FFI pain subscore related to the worst foot pain experienced over the last two weeks.
To report the final results, participants from intervention A (Orthofeet) and intervention B (own shoes) were combined from groups AB and BA.
Measured: baseline, week 6
Secondary outcomes (6)
Step Count
Step count will be measured over the course of 6 weeks for each intervention arm (Intervention A (Orthofeet) and Intervention B (own shoes)) using a smartwatch (Vivosmart 4, Garmin, USA). Steps per day were recorded in 15-min intervals and summed over each 24-h period. For analysis, the mean daily steps from the last seven consecutive days of each footwear condition (A and B) were calculated for each participant.
Measured: from baseline to 6 weeks
Daily Energy Expenditure
Active kilocalories (calories burned through physical activity, excluding basal metabolic rate) measured by the smartwatch (Vivosmart watch, Garmin) over the last seven consecutive days were extracted for each intervention period: A (Orthofeet) and B (own shoes). The 90th percentile of daily active kilocalories recorded by the smartwatch from baseline to 6 weeks was included in the analysis.
Measured: from baseline to 6 weeks
Pain Score at Baseline and Week 6
Foot pain at baseline and 6 weeks for each intervention (Orthofeet and own shoes) will be assessed using the Foot Function Index (FFI) questionnaire. The pain subscale asks participants to rate their foot pain on a scale from 0 (no pain) to 10 (worst imaginable pain) based on their experiences during various activities over the past two weeks. Seven of the nine questions were summed for final analysis, excluding "pain walking with orthotics" and "pain standing with orthotics," as the focus was to compare Orthofeet shoes to participants' own shoes, not prescribed orthoses. The resulting total score ranges from 0 to 70, with higher values indicating worse overall pain.
Measured: baseline, week 6
Disability at Baseline and Week 6
The disability level at baseline and week 6 was assessed using the disability subscale of the Foot Function Index (FFI). This subscale consists of nine items that evaluate the difficulty experienced in performing various functional activities due to foot problems. These activities include walking inside and outside the house, climbing and descending stairs, getting out of a chair, standing on tiptoe, climbing curbs, and running or fast walking.
Each item is rated on a scale from 0 (no difficulty) to 10 (so difficult it requires help). The scores for the disability subscale range from 0 to 90, with higher scores indicating greater disability.
Measured: baseline, week 6
Physical Activity Limitation
Physical activity limitations at baseline and were assessed using the Activity Limitation subscale of the Foot Function Index (FFI). This subscale comprises five items that evaluate the extent to which foot problems restrict a person's physical activities, including walking distances, standing on tiptoe, climbing stairs, and engaging in vigorous activities.
Each item is rated on a scale from 0 (no limitation) to 10 (maximum limitation), with higher scores indicating greater activity limitation. The total score for this subscale ranges from 0 to 50.
In this study, changes from baseline at week 6 for each intervention duration were assessed and reported.
In this study the changes from baseline at week 6 for each intervention duration was assessed and reported
Measured: baseline, week 6
Daily Metabolic Equivalent of Task (METS)
We used a Garmin smartwatch to report the Daily Metabolic Equivalent of Task (METs). Median daily MET values over the last seven consecutive days for each participant, during each footwear condition (Orthofeet shoes and their own shoes), were calculated following the guidelines of the American College of Sports Medicine (ACSM) and the American Heart Association (AHA) (Haskell et al., 2007).
To calculate MET-minutes per week (MET·min·wk-¹), the median daily METs were multiplied by 60, as recommended by ACSM and AHA. The mean values for the calculated "Median daily MET" across all participants, during periods when they wore Orthofeet shoes and their own shoes, were computed and reported.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start18 Jul 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Foot PainStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bijan Najafi, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Orthofeet, Inc.
- Responsible party
- Sponsor-investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434078
- Sponsor's protocol ID
- 51229
- Status last verified
- Dec 2024
- First submitted
- 22 Jun 2022
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts
Publications
Finco MG, Ouattas A, El-Refaei N, Momin AS, Azarian M, Najafi B. Assessing the Acceptability and Effectiveness of a Novel Therapeutic Footwear in Reducing Foot Pain and Improving Function among Older Adults: A Crossover Randomized Controlled Trial. Gerontology. 2024;70(8):842-854. doi: 10.1159/000539307. Epub 2024 May 22.
PubMed 38776890Ouattas A, Finco MG, Dehghan Rouzi M, Azarian M, Rojas AZ, Bargas Ochoa M, El-Refaei N, Momin A, Najafi B. The role of therapeutic footwear to increase daily physical activity in older adults with chronic foot pain. Clin Biomech (Bristol). 2025 Mar;123:106373. doi: 10.1016/j.clinbiomech.2024.106373. Epub 2024 Oct 29.
PubMed 39954566
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthofeet: A Prospective Proof of Concept Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Pain Relief Footwear
- ClinicalTrials.gov ID
- NCT05434078
- Acronym / sponsor ID
- 51229
- Conditions
- Foot Pain
- Keywords
- foot pain, falls, frailty, footwear, mobility
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bijan Najafi, PhDUniversity, hospital or other
- Collaborators
- Orthofeet, Inc.
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Posted 24 Dec 2024
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 prospective randomized crossover study is to evaluate the effectiveness of a new pain relief footwear, Orthofeet, in reducing foot pain and improving daily physical activity. The investigators hypothesize that wearing Orthofeet shoes will lead to a reduction in foot pain, resulting in increased daily physical activity, objectively measured using validated wearable devices.
Detailed description
A clinical study at Baylor College of Medicine is being conducted to evaluate the short- and intermediate-term benefits and effectiveness of a novel pain relief footwear, Orthofeet. This 12-week randomized crossover trial aims to recruit 50 eligible ambulatory adults (aged 50 years or older) with moderate self-reported foot pain. Participants will be randomly assigned to Group AB (25 subjects) or Group BA (25 subjects), with no differences in assessments or eligibility criteria between the groups. In Group AB, participants will wear Orthofeet shoes for 6 weeks, followed by their own shoes for another 6 weeks, while Group BA will follow the reverse order. Pain and function, the primary outcomes, will be measured using the Foot Function Index (FFI), and acceptability will be assessed using a Technology Acceptance Model (TAM) questionnaire. Data will be collected at baseline, 6 weeks, and 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group AB | Active comparator | Device: Orthofeet ShoesGroup AB will be started with 6-week Intervention A (OrthoFeet) and then switched to 6-week intervention B (own shoes) |
| Group BA | No intervention | –Group BA will be started with B (own shoes) for 6 weeks and then switched to Intervention A (OrthoFeet) for the same duration |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50 years or older
- self reported foot pain including heel, arch, or ball of foot
Key exclusion criteria (6 listed)
- Plantar ulcer Patients with major foot deformity (e.g., Charcot foot, Pes Cavus)
- Lower extremity amputation including minor amputation. Foot pain because of nail disorder or keratotic lesions (e.g. corns, calluses)
- unstable conditions such as recent stroke, anticipated changes in medication regime
- Acute fractures of the foot
- Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance.
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 |
|---|---|---|
| Orthofeet ShoesParticipants will wear a pair of Orthofeet shoes to wear for 6 weeks | Device | Group AB |
Primary outcome
Foot Pain at Its Worst at Baseline and Week 6
Time frame: baseline, week 6
Changes in foot pain from baseline to 6 weeks for each intervention (Orthofeet and own shoes) will be assessed using the Foot Function Index (FFI) questionnaire. The FFI consists of four overall scores, including three subscales: 1) Pain Score (the primary outcome in this study), 2) Disability Score, 3) Activity Limitation Score, and 4) Overall Score. The Pain subscale asks participants to rate their foot pain on a scale of 0 (no pain) to 10 (worst imaginable pain), based on their experiences during various activities over the past two weeks. For this outcome, we focused on the FFI pain subscore related to the worst foot pain experienced over the last two weeks. To report the final results, participants from intervention A (Orthofeet) and intervention B (own shoes) were combined from groups AB and BA.
6 secondary outcomes
Step Count
Time frame: from baseline to 6 weeks
Daily Energy Expenditure
Time frame: from baseline to 6 weeks
Pain Score at Baseline and Week 6
Time frame: baseline, week 6
Disability at Baseline and Week 6
Time frame: baseline, week 6
Physical Activity Limitation
Time frame: baseline, week 6
Daily Metabolic Equivalent of Task (METS)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38776890Finco MG, Ouattas A, El-Refaei N, Momin AS, Azarian M, Najafi B. Assessing the Acceptability and Effectiveness of a Novel Therapeutic Footwear in Reducing Foot Pain and Improving Function among Older Adults: A Crossover Randomized Controlled Trial. Gerontology. 2024;70(8):842-854. doi: 10.1159/000539307. Epub 2024 May 22.
- Background: PubMed 39954566Ouattas A, Finco MG, Dehghan Rouzi M, Azarian M, Rojas AZ, Bargas Ochoa M, El-Refaei N, Momin A, Najafi B. The role of therapeutic footwear to increase daily physical activity in older adults with chronic foot pain. Clin Biomech (Bristol). 2025 Mar;123:106373. doi: 10.1016/j.clinbiomech.2024.106373. Epub 2024 Oct 29.
- Individual participant dataSharing planned: Undecided. Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Orthofeet Shoes in people with Foot Pain, run by Bijan Najafi, PhD at 1 site in United States.
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 2 inclusion and 6 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 24 Dec 2024. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Foot Pain at Its Worst at Baseline and Week 6 (time frame: baseline, week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05434078, which also lists 2 linked publications.
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 24 Dec 2024.