Can a lipid cream stop healed wounds from reopening?
NCT ID NCT02577120
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2019
- Expected to finish
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Feb 2034
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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University of Pittsburgh / McKeesport Clinic
Pittsburgh, Pennsylvania, 15132, United States
-
University of Pittsburgh / Mercy Clinic
Pittsburgh, Pennsylvania, 15219, United States
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University of Pittsburgh / Passavant
Pittsburgh, Pennsylvania, 16066, United States
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