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NCT Number: NCT07166016

Treatment Effects on Gait in Hammertoe Patients

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Rio Grande Valley

Harlingen, Texas, 78550, United States

Location status: Recruiting

Location contact

Hafizur Rahman, PhD

CONTACT

[email protected]

956-296-2035

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conservative

Other

Patients with hammertoe deformities will undergo conservative treatments, including wearing proper shoes, insoles, and custom orthotics.

Surgical

Procedure

Patients with hammertoe deformities will undergo surgical treatments.

Primary outcomes

  1. In-shoe Peak Plantar Pressure

    Time frame: 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 outcomes

  1. Quality of Life Questionnaire

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Hafizur Rahman, PhD

CONTACT

[email protected]

956-296-2035

Sponsors and collaborators

Lead sponsor

University of Texas Rio Grande Valley

Other

Registry information

Official study title

Evaluating the Effectiveness of Treatments on Gait Biomechanics in Patients With Hammertoe Deformities

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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