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Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear

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ClinicalTrials.gov Identifier: NCT05434078
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : June 27, 2022
Sponsor:
Collaborator:
Orthofeet, Inc.
Information provided by (Responsible Party):
Bijan Najafi, PhD, Baylor College of Medicine

Brief Summary:
The purpose of this prospective proof of concept study is to examine the effectiveness of a new pain relief footwear (Orthofeet) on function and daily activities. We hypothesize that Orthofeet will reduce foot pain leading to an increase in daily physical activities, measured objectives using validated wearables (PAMSys and Garmin wristwatch), and functional performance (gait and balance). In addition, we hypothesis that reduction in foot pain is associated with reduced physiological stress response (HRV) and better community engagement (assessed by life space questionnaire).

Condition or disease Intervention/treatment Phase
Foot Pain Device: Orthofeet Shoes Phase 2

Detailed Description:
We are proposing a clinical study at the Baylor College of Medicine, to evaluate short and intermediate benefits and effectiveness of a novel pain relief footwear, called Orthofeet. This is a randomized crossed over trial. The duration of the study would be 12-week. We will recruit 50 eligible ambulatory adults (age 50 years or older) with moderate to severe self-reported foot pain. Participants will be randomly assigned to Group A (25 subjects) and Group B (25 subjects). There is no difference in assessments or eligibility between Group A and Group B, the only difference is when they have the opportunity to try the shoes for 6 weeks. Group A will receive a pair of Orthofeet shoes with adjustable insoles and will be asked to wear it every day activities of daily living for duration of six weeks. Participants will be also encourage to wear the shoes inside of home if possible. Group B will be followed for duration of six weeks. At six weeks the groups will be switched and group B will receive and a pair of Orthofeet shoes with adjustable insoles and Group B will follow-up for six week without Orthofeet shoes. Participants will be assessed at baseline, week-1, week-6, week 7, and week 12.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Orthofeet: A Prospective Proof of Concept Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Pain Relief Footwear
Actual Study Start Date : June 15, 2022
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Orthofeet Shoes
Participants will be given Orthofeet shoes to wear for 6 weeks
Device: Orthofeet Shoes
Participants will wear a pair of Orthofeet shoes to wear for 6 weeks

No Intervention: No Orthofeet shoes
This group will not be wearing Orthofeet shoes for 6 weeks



Primary Outcome Measures :
  1. Change in Foot Pain Intensity [ Time Frame: baseline, 1 week, 6 weeks, 7 weeks, 12 weeks ]
    Changes in foot pain from baseline to 12 weeks will be assessed by Foot Function Index (FFI) questionnaire. Score ranges from 0 to 230, the higher the score indicates greater disability/decreased foot function.


Secondary Outcome Measures :
  1. Change in Physical Activity [ Time Frame: baseline, 6 weeks, and 12 weeks ]
    Changes in physical activity from baseline to 12 weeks will be assessed. Physical activity will be quantified by measuring number of taken steps per day and will be measured using a validated wearable sensor named PAMSys. Monitoring of physical activity will be done during 48hours at baseline, 6 weeks, and at 12 weeks.

  2. Change in Quality of Life [ Time Frame: baseline, 6 weeks, and 12 weeks ]

    Quality of life will be assessed using a validated questionnaire, called PROMIS Global-10.

    The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.


  3. Change in Gait speed [ Time Frame: baseline, 6 weeks, and 12 weeks ]
    Change from baseline in Gait speed at 12 weeks. Gait speed will be measured using a validated wearable platform (LEGSys) during habitual walking speed.

  4. Change in Balance [ Time Frame: baseline, 6 weeks, and 12 weeks ]
    Change in balance from baseline to 12 weeks will be measured. Balance will be assessed by measuring center of mass sway. The investigator will use a validated wearable platform (BalanSen) to measure body sway.

  5. Change in Fear of Falling [ Time Frame: baseline, 6 weeks, and 12 weeks ]
    Changes in Fear of falling will be assessed by Short Falls Efficacy Scale International (FES I) questionnaire at 12 weeks and will be compared to baseline measurements. Scores range from 16 to 64, the higher the score the more concerned the subject is with falling.

  6. Change in Cognitive Function [ Time Frame: baseline, 6 weeks, and 12 weeks ]
    Changes from baseline in cognitive function at 12 weeks. Cognitive performance will be assessed using Montreal Cognitive Assessment (MoCA). Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50 years or older
  • self reported foot pain including heel, arch, or ball of foot

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05434078


Contacts
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Contact: Bijan Najafi, PhD 713-798-7536 bijan.najafi@bcm.edu
Contact: Maria Noun, BS 713-798-7537 maria.noun@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Maria Noun, BS    713-798-7537    maria.noun@bcm.edu   
Contact: Bijan Najafi, PhD    713-798-7536    bijan.najafi@bcm.edu   
Principal Investigator: bijan najafi, phd         
Sponsors and Collaborators
Bijan Najafi, PhD
Orthofeet, Inc.
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Responsible Party: Bijan Najafi, PhD, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05434078    
Other Study ID Numbers: 51229
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:
foot pain
falls
frailty
footwear
mobility