TerminatedNot Applicable

A Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds

Stopped: The primary reason for this early termination is insufficient enrollment, compounded by recruitment challenges and Impending Expiry of Study Product

Canada, Puerto Rico7 participantsStarted 2024-05-30

Plain-language summary

The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.

Who can participate

Age range

18 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.

Exclusion criteria

. Ankle Brachial Index (ABI) \<0.7
. Toe Brachial Index (TBI) \<0.5
. Great toe pressure \<40mmHg
. Abnormal triphasic or biphasic waveform patterns at the ankle \*\*This criteria is not applicable for patients having an above, or below knee amputation.

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

Wound Healing Status

Timeframe: End of treatment period, up to 3 weeks

Trial details

NCT IDNCT06306716

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Chronic Wounds trials