Clinical Outcomes Related to Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves: A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- INCREDIWEAR HOLDINGS, INC.
- Enrollment
- 115
- Primary Endpoint
- Change in participant Foot and Ankle Outcome Score (FAOS)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Active Device
Semiconductor Embedded Ankle Sleeve and Sock
Intervention: Semiconductor embedded ankle sleeve and sock (Device)
Placebo Device
Identical device absent of semiconductors
Intervention: Placebo ankle sleeve and sock (Device)
Outcomes
Primary Outcomes
Change in participant Foot and Ankle Outcome Score (FAOS)
Time Frame: 3 months
Changes in participant function and pain as determined by the Foot and Ankle Outcome score (FAOS) FAOS: Lowest score: 0 (extreme symptoms/limiations) Highest score: 100 (no symptoms or limitations)
Secondary Outcomes
- Change in participant Foot Function Index (FFI)(3 months)
- Changes in participant American Orthopedic Foot and Ankle Society-Hallux Valgus Score (AOFAS)(3 months)
- Participant-reported changes in pain(3 months)
- Changes in oral medication intake compared to placebo group(3 months)
- Changes in swelling of the foot compared to placebo group(3 months)
- Changes in participant soft tissue thickness compared to placebo group(3 months)