Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves (NCT07422623) | Clinical Trial Compass
By InvitationNot Applicable
Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves
United States115 participantsStarted 2026-03-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in participant Foot and Ankle Outcome Score (FAOS)