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Wound healing device study pulled before starting

NCT ID NCT05666570

Symptom relief Sponsor: ConvaTec Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study was designed to test the safety and performance of the Avelle negative pressure wound therapy system on chronic wounds, including diabetic foot ulcers and venous leg ulcers. The device uses gentle suction to help wounds heal. However, the study was withdrawn before enrolling any participants, so no results are available.

What this could mean

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

Active substance
Avelle negative pressure wound therapy system (device)

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.

Started

May 2022

Finished

Mar 2023

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

The population will be recruited from the Investigators available population in the anticipated geographies of Colombia and Australia.

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: * Venous insufficiency as defined by CEAP Classification of C6 or C6R or Diabetic foot ulcer * Stalled wound/failed treatment in the opinion of the investigator. Defined as a wound that has not progressed by more than 30% in the previous 4 weeks * 1 qualifying wound which is amenable to NPWT * Reliable and available for follow-up * Low to moderate exudate * Able to tolerate negative pressure * \>18 years old at the time of consent * Able and willing to provide informed consent Exclusion Criteria: * Known sensitivities or allergies to components of the Avelle™ Negative Pressure Wound Therapy System * Necrotic wounds or wounds with eschar present * Wound is too small or too large based on wound dressing (\> 1cm2 and \< 100cm2) * Wound depth \>2cm * Use of DuoDERM® gel /petroleum gel/ creams/oil-based products * Active treatment for cancer or completed within the last 3 months * Severe malnutrition in the opinion of the investigator * Visible bone/tendon or exposed articular capsule * Exposed blood vessels * Clotting disorder * Malignant wounds * Systemic infection * Untreated osteomyelitis * Patients with HbA1c greater than 9 on Day 0 (Test to be performed within last 3 months) * Wounds greater than 12 months old * Previous failed NPWT within last 6 weeks on the qualifying wound * Active Pregnancy * Chronic Kidney Disease score of 5

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Conditions

The condition(s) this trial relates to.

Diabetic Foot ulcer disease ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

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

Diabetic foot ulcer Venous leg ulcer

Contacts and locations

Locations

  • Convatec Medical Care

    Bogota, Cundinamarca, 11001000, Colombia

More trials for these conditions

Other studies related to the condition(s) this trial covers.