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New wound vacuum device tested for leg amputation recovery

NCT ID NCT06493539

Symptom relief Sponsor: University of Southern California Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study aimed to test a special wound vacuum device (CiNPWT) on people who had a leg amputation. The device applies gentle suction to the closed incision to reduce swelling and help healing. Researchers planned to compare it to standard wound care in about 6-10 adults, but the study was withdrawn before any participants were enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Closed incision negative pressure wound therapy (CiNPWT) device
What this could lead to
If it works, this could point toward a better way to manage wounds after leg amputation, potentially reducing swelling and speeding recovery.
What could go wrong
This is a very small pilot study (6-10 people) that was withdrawn before enrolling anyone, so no results are available. The approach may not prove better than standard care.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Expected to start

Jul 2024

An estimate. Start dates often move.

Expected to finish

Jun 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 to select the participants (intervention and control): * Individual aged 18 years or older * Individual with a closed incision following LEA (transmetatarsal or proximal) * Individual presents with adequate perfusion based on WIfI ischemia component score of less than 2 (\>30mm Hg TCPO2 or higher at region of amputation) * Individual presents with no residual surgical site infection (WIfI grade 0) post LEA * Individual is competent to make their own medical decisions Exclusion criteria (intervention and control): * Individual presents with any defined contraindications to NPWT (e.g., allergy). * Individual presents with residual acute osteomyelitis (after amputation). * Individual with collagen vascular disease or malignant disease in the wound * Individual has uncontrolled hyperglycemia (glycosylated hemoglobin \[HbA1c\]\>12%). * Individual is currently taking corticosteroids, immunosuppressive drugs, or chemotherapy and is not on stable course of therapy as determined by principal investigator * Individual has a history of local radiation therapy that could impact the edema of the amputated limb. * Individual has pre-existing conditions contributing to residual limb edema (i.e., nephropathy, congestive heart failure, primary lymphedema, etc.). Withdrawal of individuals: * Voluntary withdrawal * Death * Lost to follow-up * Termination of compression therapy (control or intervention group)

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As listed by the trial registrant

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

Wound dehiscence Wound heal

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