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Treatment Effects on Gait in Hammertoe Patients

NCT ID: NCT07166016

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Hammertoe

Keywords

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Hammertoe Plantar pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conservative Treatment

Group Type EXPERIMENTAL

Conservative

Intervention Type OTHER

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

Surgical Treatment

Group Type EXPERIMENTAL

Surgical

Intervention Type PROCEDURE

Patients with hammertoe deformities will undergo surgical treatments.

Interventions

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Conservative

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

Intervention Type OTHER

Surgical

Patients with hammertoe deformities will undergo surgical treatments.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Rio Grande Valley

OTHER

Sponsor Role lead

Responsible Party

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Hafizur Rahman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Texas Rio Grande Valley

Harlingen, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hafizur Rahman, PhD

Role: CONTACT

Phone: 956-296-2035

Email: [email protected]

Facility Contacts

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Hafizur Rahman, PhD

Role: primary

Other Identifiers

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IRB-24-0101

Identifier Type: -

Identifier Source: org_study_id