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Набор по приглашению NCT07422623

Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves

Без фазы С лечением Hallux Valgus Deformity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Semiconductor embedded ankle sleeve and sock, Placebo ankle sleeve and sock.
Кому может быть актуально
Состояния в реестре: Hallux Valgus Deformity. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Foot and Ankle Center of Iowa — Ankeny

Идентификаторы

NCT: NCT07422623 · 2025-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗