HammertoeNCT07166016
Treatment Effects on Gait in Hammertoe Patients
A study testing Conservative and Surgical in people with Hammertoe, run by University of Texas Rio Grande Valley at 1 site in United States.
Trial summary
This study looks at how hammertoe deformities affect foot pressure distribution and whether proper treatment can improve quality of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hammertoe
- What is being tested?
- Conservative and Surgical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed distal symmetric sensory neuropathy.
- MTPJ hyperextension deformity.
- Claw or hammer toe deformity in toes.
Who cannot join
- 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
Show all 11Show fewer
- Current foot ulcer or edema
- Inability to walk unaided
- MRI contraindications
- Morton's neuroma
- History of foot surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Rio Grande Valley
Harlingen, Texas, 78550
Hafizur Rahman, PhD, 956-296-2035, hafizur.rahman@utrgv.edu
About this study
Official title: Evaluating the Effectiveness of Treatments on Gait Biomechanics in Patients With Hammertoe Deformities
This study looks at how hammertoe deformities affect foot pressure distribution and whether proper treatment can improve quality of life.
Read the 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).
- Conditions
- Hammertoe
- Being tested
- Conservative, Surgical
- Keywords
- Hammertoe, Plantar pressure
- Medical subject headings
- Hammer Toe Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConservativeOther
Patients with hammertoe deformities will undergo conservative treatments, including wearing proper shoes, insoles, and custom orthotics.
SurgicalProcedure or surgery
Patients with hammertoe deformities will undergo surgical treatments.
| Study group | Role | What they receive |
|---|---|---|
| Conservative Treatment | Experimental | Not described Receives: Other: Conservative |
| Surgical Treatment | Experimental | Not described Receives: Procedure: Surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-shoe Peak Plantar Pressure
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).
Measured: Pre-intervention, Post-intervention (3 months)
Secondary outcomes (1)
Quality of Life Questionnaire
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).
Measured: Pre-intervention, Post-intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HammertoeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Rio Grande Valley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafizur Rahman, University of Texas Rio Grande Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166016
- Sponsor's protocol ID
- IRB-24-0101
- Status last verified
- Nov 2025
- First submitted
- 2 Sep 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified and anonymous dataset will be created for sharing purposes. The dataset will only be shared upon reasonable request and with a written agreement from the recipient. All outcomes, results, and findings will be published in peer-reviewed journals and conference proceedings.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Treatments on Gait Biomechanics in Patients With Hammertoe Deformities
- ClinicalTrials.gov ID
- NCT07166016
- Acronym / sponsor ID
- IRB-24-0101
- Conditions
- Hammertoe
- Keywords
- Hammertoe, Plantar pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Texas Rio Grande ValleyUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Treatment | Experimental | Other: Conservative |
| Surgical Treatment | Experimental | Procedure: Surgical |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed distal symmetric sensory neuropathy.
- MTPJ hyperextension deformity.
- Claw or hammer toe deformity in toes.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConservativePatients with hammertoe deformities will undergo conservative treatments, including wearing proper shoes, insoles, and custom orthotics. | Other | Conservative Treatment |
| SurgicalPatients with hammertoe deformities will undergo surgical treatments. | Procedure or surgery | Surgical Treatment |
Primary outcome
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).
1 secondary outcome
Quality of Life Questionnaire
Time frame: Pre-intervention, Post-intervention (3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: Yes. A de-identified and anonymous dataset will be created for sharing purposes. The dataset will only be shared upon reasonable request and with a written agreement from the recipient. All outcomes, results, and findings will be published in peer-reviewed journals and conference proceedings.
Related trials for Hammertoe
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Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)
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RecruitingPhase 3
Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)
Flexible Hammertoe, Semi-flexible Hammertoe
Not yet recruiting
Mg Alloy DrillPins in Hammertoe Deformity Correction
Hammertoe, Hammer Toe Syndrome
Recruiting
Flexor Tenotomy and Ulcer Recurrence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative and Surgical in people with Hammertoe, run by University of Texas Rio Grande Valley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafizur Rahman, PhD (956-296-2035, hafizur.rahman@utrgv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-shoe Peak Plantar Pressure (time frame: Pre-intervention, Post-intervention (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.