Skip to content

Treatment Effects on Gait in Hammertoe Patients

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07166016
Enrollment
30
Registered
2025-09-10
Start date
2025-10-01
Completion date
2027-12-31
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hammertoe

Keywords

Hammertoe, Plantar pressure

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).

Interventions

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

PROCEDURESurgical

Patients with hammertoe deformities will undergo surgical treatments.

Sponsors

University of Texas Rio Grande Valley
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
In-shoe Peak Plantar PressurePre-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

MeasureTime frameDescription
Quality of Life QuestionnairePre-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).

Countries

United States

Contacts

Primary ContactHafizur Rahman, PhD
hafizur.rahman@utrgv.edu956-296-2035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026