By InvitationNot Applicable

Outcomes for VersaWrap in Achilles Tendon Repair

United States400 participantsStarted 2025-05-13

Plain-language summary

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

Who can participate

Age range

18 Years – 90 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 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

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

Skin Excursion

Timeframe: 12 months post surgery

Range of Motion (ROM)

Timeframe: 12 months post surgery

Trial details

NCT IDNCT07025252

SponsorResearch Source

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2028-06

View on ClinicalTrials.gov More Achilles Tendon Injury trials