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New wound vacuum dressing shows promise in small study

NCT ID NCT06306716

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new type of wound vacuum dressing on 7 people with chronic or acute wounds. The goal was to see if the dressing helps wounds heal or get better. The study was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

7 people

The number who actually took part.

Started

May 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study aims to enroll up to 42 subjects from clinical sites in the United States and Canada with appropriate wound types including: * Chronic\* (this may include DFUs, VLUs, Pressure Ulcers but this is not an exhaustive list) * Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns, but this is not an exhaustive list) \*Chronic wound in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause. As this is a pilot study, there are no limits to the inclusion of any particular wound type (chronic or acute) or inpatient/outpatient care at time of enrollment. Patients must be able to attend follow-up visits in clinic if they are receiving outpatient care.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject has provided written informed consent. * Subject is 18 years of age or over. * Subject is able and willing to comply with study requirements. * Subject is suitable to participate in the study in the opinion of the Investigator. . * Subject has a wound(s) that, per Instructions for Use (IFU), is indicated and suitable for management with NPWT and fits one of the following wound types: a. Chronic\* (this may include Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers but this is not an exhaustive list) b. Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns) \*Chronic wound(s) in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause * Subject's wound to be treated is of a size that can be managed with one of the available sizes of the study device Exclusion Criteria: * Subject has hypersensitivity to the use of the RENASYS NPWT System or its components, or a contraindication per the IFU such as: a. exposed arteries, veins, organs, or nerves b. necrotic tissue with eschar present (unless adequately debrided) c. non-enteric and unexplored fistulas d. exposed anastomotic site e. malignancy in the wound * Subject participation in the treatment period of another clinical trial within thirty (30) days of baseline visit or during the study. * Subject has skin features (e.g., tattoos, pre-existing scarring, etc.) which in the opinion of the investigator will interfere with the study assessments. * For lower extremity wounds\*\*, any subject with a wound on a limb with an inadequate arterial supply confirmed by one of the following within 14 days of treatment: 1. Ankle Brachial Index (ABI) \<0.7 2. Toe Brachial Index (TBI) \<0.5 3. Great toe pressure \<40mmHg 4. Abnormal triphasic or biphasic waveform patterns at the ankle \*\*This criteria is not applicable for patients having an above, or below knee amputation. * Any subject that meets the definition of a Vulnerable Subject per ISO 14155 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response). Ethnic minorities will be included providing they meet other inclusion criteria. * Subject has had the target wound for greater than three months. * Subject has a target wound that measures \<3 millimeters (mm) in maximum depth. * Subject has untreated osteomyelitis * Subject has active, untreated soft tissue infection. * Subject has wounds that has been managed with NPWT in the previous four (4) weeks * Subject has participated previously in this clinical trial. * Subject has a history of poor compliance with medical treatment. * Pregnancy at time of enrolment. * Subject has a medical or physical condition that in the opinion of the Investigator would preclude safe subject participation in the study.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic ulcer of skin injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Lawson Health Research Institute

    London, Ontario, N6C 2R5, Canada

  • Wound Care Plus Research and Education Center

    San Juan, PR, 00918, Puerto Rico

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