Status:
COMPLETED
Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear
Lead Sponsor:
Bijan Najafi, PhD
Collaborating Sponsors:
Orthofeet, Inc.
Conditions:
Foot Pain
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
PHASE2
Brief 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. The i...
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 rando...
Eligibility Criteria
Inclusion
- 50 years or older
- self reported foot pain including heel, arch, or ball of foot
Exclusion
- 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
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05434078
Start Date
July 18 2022
End Date
August 30 2024
Last Update
December 24 2024
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030