Treatment Effects on Gait in Hammertoe Patients
Evaluating the Effectiveness of Treatments on Gait Biomechanics in Patients With Hammertoe Deformities
1 other identifier
interventional
30
1 country
1
Brief Summary
This study looks at how hammertoe deformities affect foot pressure distribution and whether proper treatment can improve quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2025
CompletedFirst Posted
Study publicly available on registry
September 10, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
November 10, 2025
November 1, 2025
2.2 years
September 2, 2025
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-shoe Peak Plantar Pressure
In-shoe peak plantar pressure data will be recorded as patients walk with a pressure-measuring sensor placed inside their shoes. The unit will be Kilopascal (kPa).
Pre-intervention, Post-intervention (3 months)
Secondary Outcomes (1)
Quality of Life Questionnaire
Pre-intervention, Post-intervention (3 months)
Study Arms (2)
Conservative Treatment
EXPERIMENTALSurgical Treatment
EXPERIMENTALInterventions
Patients with hammertoe deformities will undergo conservative treatments, including wearing proper shoes, insoles, and custom orthotics.
Patients with hammertoe deformities will undergo surgical treatments.
Eligibility Criteria
You may qualify if:
- Confirmed distal symmetric sensory neuropathy.
- MTPJ hyperextension deformity.
- Claw or hammer toe deformity in toes.
You may not qualify if:
- Non-hammertoe foot deformities affecting metatarsal head pressure.
- Limited joint mobility, lower-limb amputation, or Charcot neuro-osteoarthropathy.
- Peripheral vascular disease
- Non-diabetic neuropathies
- Significant lower-limb musculoskeletal issues
- Rheumatoid arthritis
- Current foot ulcer or edema
- Inability to walk unaided
- MRI contraindications
- Morton's neuroma
- History of foot surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Rio Grande Valley
Harlingen, Texas, 78550, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 2, 2025
First Posted
September 10, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The de-identified and anonymous dataset will only be shared after the study is completed and results are published in peer-reviewed journals and conference proceedings.
A de-identified and anonymous dataset will be created for sharing purposes. The dataset will only be shared upon reasonable request and with a written agreement from the recipient. All outcomes, results, and findings will be published in peer-reviewed journals and conference proceedings.