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OpenTrials
Enrolling by Invitation

NCT Number: NCT07025252

Outcomes for VersaWrap in Achilles Tendon Repair

The purpose of this study is to evaluate the efficacy on the use of VersaWrap® in surgery of the foot and ankle. VersaWrap is designed to allow tendon gliding and to protect tendon gliding postoperatively

Enrolling by Invitation

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Foot and Ankle Orthopaedics Clinic, Sacramento, California, United States

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About this study

This is a prospective, multi-center, controlled case series evaluating the use of VersaWrap in surgeries of the foot and ankle. Patients identified by the Investigator in his practice as needing surgery for an Achilles primary or elective insertional repair and meeting all the inclusion and none of the exclusion. Patients will consent to participating in the study, prior to any study procedures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients that require surgery for Achilles primary or elective insertional repair. Note: primary repair must be conducted within 6 weeks of injury. Additional repairs may be conducted during surgery, confirm with study Sponsor prior to enrollment. Insertional repairs due to trauma are not eligible.
  • Able to understand the requirements of the study, provide a written consent, and willing to comply with the study protocol
  • Age ≥18 years and <90 years at the time of surgery

Exclusion criteria

  • Investigator determines that the subject is unlikely to comply with the requirements of the study
  • Active systemic infection or infection at the location planned surgery
  • Uncontrolled diabetes
  • Prior Achilles surgery on either ankle
  • Active or suspected malignancy. If symptom free for 2 years, patients with prior malignancy may be included
  • Morbid obesity defined as a body mass index > 40
  • Pregnant or have plans to become pregnant in the next year
  • Currently a prisoner
  • Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis)
  • Medications that could interfere with fusion or other bone/soft tissue healing (e.g., anticipated continued use of systemic steroid medication postoperatively)

Treatment and study plan

VersaWrap

Device

VersaWrap is applied to the affected tendon to allow post-operative gliding.

Primary outcomes

  1. Skin Excursion

    Time frame: 12 months post surgery

    Skin excursion will be measured by examining the movement that is regularly repeated in a portion of involved skin in comparison to movement of the skin in the peroneal region of the contralateral foot. A ruler will be utilized to measure the up and down movement at the center of the skin excision, to determine the exact amount of excursion of the center of the wound.

  2. Range of Motion (ROM)

    Time frame: 12 months post surgery

    Standing dorsi- and plantarflexion of the affected and contralateral ankle will be measured using a handheld goniometer, referencing the long axis of the fibula and fifth metatarsal shaft. Both passive and active range of motion will be captured. The greater the ROM the better the outcome.

Sponsors and collaborators

Lead sponsor

Research Source

Network

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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