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Can a lipid cream stop healed wounds from reopening?

NCT ID NCT02577120

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests whether a special lipid cream (EpiCeram) can prevent healed chronic wounds—like diabetic foot ulcers or pressure sores—from reopening. About 100 adults with recently healed wounds will apply either the cream or Vaseline for 3 months. Researchers will measure skin barrier function to see if the cream helps wounds stay closed.

What this could mean

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

Active substance
EpiCeram (lipid-rich cream) and Vaseline (petroleum jelly)
What this could lead to
If successful, this could point toward a simple cream to reduce the chance that a healed chronic wound reopens.
What could go wrong
This is an early-phase study with a small number of participants, so results may not apply broadly. The cream is compared to Vaseline, and the main measure (TEWL) is a skin function test, not a direct clinical outcome.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2019

Expected to finish

Feb 2034

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

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: 1. Age ≥ 18 2. Willing to comply with protocol instructions, including all study visits and study activities. 3. One of the following: Healed wound (within 10 days prior to consent/screening visit) that was previously a chronic wound of multiple etiologies and open for at least30 days, including: i. Diabetic foot ulcers, Wagner grade 1-3 ii. Pressure ulcers, stage 2-3 iii. Venous leg ulcers, confirmed by venous duplex iv. Burn wounds 4. If candidate has a diabetic foot ulcer, ABI score measurement at Visit 1 must be between 0.7 and 1.2. If score is below or above, candidate will be considered a screen fail. Score can be gathered from EMR in previous 3 months to visit 1 if done as SOC or completed during visit 1. Exclusion Criteria: 1. Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent). 2. Subjects with marked immunodeficiency (HIV/AIDS, organ transplant patients and cancer patients and patients with autoimmune disease on immunosuppressive medications). 3. Wounds closed or to be closed by flap or graft coverage - including stage 4pressure ulcers and Wagner grade 4 or 5 diabetic foot ulcers. 4. Prisoners 5. Patients with allergies to petrolatum 6. Patients who are currently enrolled in another research study which includes investigational treatment and/or medication 7. Patients with an HbA1c score greater than 10.0 at Visit 1, will be considered a screen fail. Score can be gathered from EMR in previous 12 months to visit 1 if done as SOC, or completed during visit 1.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Pittsburgh / McKeesport Clinic

    Pittsburgh, Pennsylvania, 15132, United States

  • University of Pittsburgh / Mercy Clinic

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Pittsburgh / Passavant

    Pittsburgh, Pennsylvania, 16066, United States

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