Effect of Non-Compressive, Semiconductor Embedded Ankle sleeves

• Research type

  Research Study

• Full title

  Effect of Non-Compressive, Semiconductor Embedded Therapeutic Garments for the Treatment of Achilles Tendinopathy: A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation

• IRAS ID

  359872

• Contact name

  Paul Lee

• Sponsor organisation

  iNCREDIWEAR HOLDINGS, INC.

• Duration of Study in the UK

  1 years, 3 months, 1 days

• Research summary

  This study is designed to evaluate whether special garments, socks and ankle sleeves embedded with semiconductor materials, can help reduce pain and improve movement in people with Achilles tendinopathy, a common condition that causes pain and stiffness in the tendon at the back of the ankle. The garments are designed to emit safe levels of far-infrared waves and negative ions when worn, which may help reduce inflammation, improve blood flow, and support tendon healing.

  The study will compare the effectiveness of these active garments to identical-looking socks and sleeves that do not contain the semiconductor materials (placebo). Participants will be randomly assigned to either the active group or the placebo group, and neither the participants nor the researchers will know who is receiving which version until the study ends.

  Participants will wear the ankle sleeve for at least 12 hours during the day and the sock for at least 8 hours overnight, over a 24-week period. Throughout the study, participants will complete pain and mobility questionnaires and undergo non-invasive MRI scans to track changes in the Achilles tendon. They will also log their use of the garments and any pain relief medications taken.

  All personal information will be kept confidential and securely stored. The study will be ethically approved and registered as a clinical trial. Participants in the placebo group will be offered advice on other suitable treatments after the study finishes.

  The goal of this research is to test whether this non-invasive approach can be an effective, safe, and accessible alternative to traditional treatments such as medications or surgery. If successful, the results could inform new treatment options for people with Achilles tendinopathy and improve long-term outcomes for patients with this condition.

• REC name

  London - Camberwell St Giles Research Ethics Committee

• REC reference

  25/PR/0953

• Date of REC Opinion

  12 Aug 2025

• REC opinion

  Further Information Favourable Opinion