Recruiting

Hammertoe Deformities

Sponsor:

University of Texas Rio Grande Valley

Code:

NCT07166016

Conditions

Hammertoe

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Conservative

Surgical

Study Details

Brief summary:

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

Conditions

Hammertoe

Study ID

NCT07166016

Start date

Oct 1, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Conservative Treatment

experimental: Surgical Treatment

Interventions

Conservative

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

Surgical

Patients with hammertoe deformities will undergo surgical treatments.

Primary outcome measure

  • In-shoe Peak Plantar Pressure [ Time Frame: Pre-intervention, Post-intervention (3 months) ]

Central Contacts and Locations

Central contacts

Hafizur Rahman, PhD

956-296-2035hafizur.rahman@utrgv.edu

Locations

University of Texas Rio Grande Valley

Recruiting

Harlingen, Texas, United States, 78550

Contacts

Hafizur Rahman, PhD

956-296-2035hafizur.rahman@utrgv.edu

More Information

Sponsor

University of Texas Rio Grande Valley

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Hammertoe
  • Plantar pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Rio Grande Valley on 2025-11-10.