Treatment Effects on Gait in Hammertoe Patients

Not Applicable

Recruiting

• Conditions: Hammertoe

• Registration Number: NCT07166016
• Lead Sponsor: University of Texas Rio Grande Valley

Brief Summary

This study looks at how hammertoe deformities affect foot pressure distribution and whether proper treatment can improve quality of life.

Detailed Description

Hammertoe deformities often lead to pain, discomfort, and difficulty with walking. People affected by these deformities are also at a higher risk for developing pressure-related ulcers on their feet. It is essential for clinicians to be aware of this risk and to assess the degree of plantar pressure reduction following both conservative and surgical treatments, as alleviating this pressure may help prevent the development of foot ulcers. Individuals diagnosed with hammertoes will participate in two data collection sessions-one visit before the intervention begins (pre-intervention) and another visit three months after the intervention (post-intervention).

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Study First Posted: 2025-09-10
• Last Update Submitted: 2025-09-10
• Last Update Posted: 2025-09-17
• Study Start: 2025-10-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Confirmed distal symmetric sensory neuropathy.
• MTPJ hyperextension deformity.
• Claw or hammer toe deformity in toes.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
In-shoe Peak Plantar Pressure	Pre-intervention, Post-intervention (3 months)	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).

Secondary Outcome Measures

Name	Time	Method
Quality of Life Questionnaire	Pre-intervention, Post-intervention (3 months)	Medical Outcomes Study 36-item Short Form questionnaires (SF-36) will be used to assess the quality of life. The SF-36 form has four subsections: pain, distance, walking speed, and stair climbing. Each subsection score ranges from 0 to 100 (where 0 is the worst, and 100 is the best health status).

Trial Locations

Locations (1)

University of Texas Rio Grande Valley; 🇺🇸 Harlingen, Texas, United States