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Recruiting NCT07166016

Treatment Effects on Gait in Hammertoe Patients

No phase Interventional Hammertoe

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conservative, Surgical.
Who it may be relevant to
Registry conditions: Hammertoe. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • Other Conservative
    Patients with hammertoe deformities will undergo conservative treatments, including wearing proper shoes, insoles, and custom orthotics.
  • Procedure Surgical
    Patients with hammertoe deformities will undergo surgical treatments.

Primary outcome measures

  • In-shoe Peak Plantar Pressure [Time frame: Pre-intervention, Post-intervention (3 months)]
Secondary outcome measures (1)
  • Quality of Life Questionnaire [Time frame: Pre-intervention, Post-intervention (3 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Texas Rio Grande Valley — Harlingen

Identifiers

NCT: NCT07166016 · IRB-24-0101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗