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Enrolling by invitation NCT07422623

Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves

No phase Interventional Hallux Valgus Deformity

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: Semiconductor embedded ankle sleeve and sock, Placebo ankle sleeve and sock.
Who it may be relevant to
Registry conditions: Hallux Valgus Deformity. Basic parameters: 18 years — 75 years · 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 →

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Official title

Clinical Outcomes Related to Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves: A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation

Overview

This study is looking to test a non-compressive semiconductor embedded ankle sleeve and sock for post hallux valgus correction surgery rehabilitation. Hallux valgus (HV), commonly known as a bunion, is one of the most prevalent forefoot deformities. It affects approximately 23% of adults aged 18 to 65 and 36% of those over 65. Given the high incidence of HV, various surgical correction methods have been developed, with first tarsometatarsal (TMT) arthrodesis (Lapiplasty Arthrodesis) and first metatarsophalangeal (MTP) arthrodesis demonstrating the highest success rates in restoring function and preventing recurrence. Post-surgical symptoms typically include pain, swelling, and tenderness, but with proper rehabilitation and preventive measures, patients generally return to activity within weeks to months.The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases far infrared waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for rehabilitation post hallux valgus correction surgery.

Interventions

  • Device Semiconductor embedded ankle sleeve and sock
    The active device contains semiconductors embedded in the ankle sleeve and sock
  • Device Placebo ankle sleeve and sock
    Identical ankle sleeve and sock absent of semiconductors

Primary outcome measures

  • Change in participant Foot and Ankle Outcome Score (FAOS) [Time frame: 3 months]
Secondary outcome measures (6)
  • Change in participant Foot Function Index (FFI) [Time frame: 3 months]
  • Changes in participant American Orthopedic Foot and Ankle Society-Hallux Valgus Score (AOFAS) [Time frame: 3 months]
  • Participant-reported changes in pain [Time frame: 3 months]
  • Changes in oral medication intake compared to placebo group [Time frame: 3 months]
  • Changes in swelling of the foot compared to placebo group [Time frame: 3 months]
  • Changes in participant soft tissue thickness compared to placebo group [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Patients undergoing hallux valgus correction surgery including Lapiplasty Arthrodesis, MTP fusion, and TMT+MTP arthrodesis (double first ray arthrodesis).
  • Patients aged 18-75
  • Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
  • Patients who are willing and able to sign corresponding research subject consent form.

Exclusion criteria

  • Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
  • Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
  • Patient has had prior surgical treatment of the foot within the last 5 years
  • Patient has external hardware (wires) protruding from the foot post-surgery
  • Patient has had prior injections (PRP or Stem Cell) in the foot within the last 1 year
  • Patient has rheumatoid arthritis
  • Patient has chronic pain conditions unrelated to foot condition
  • Patient has auto-immune or auto-inflammatory diseases
  • Patient has used tobacco within the last 90 days
  • Patient has poorly controlled diabetes as determined by A1C levels > 7.0
  • Patient has an active infection (local or systemic)
  • Patient is unwilling or unable to sign the corresponding research subject consent form
  • Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Foot and Ankle Center of Iowa — Ankeny

Identifiers

NCT: NCT07422623 · 2025-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗