Wound Healing Interventions for Chronic Wounds

Not currently recruiting at 3 trial locations

Overseen By Kaitlyn Depinet, FNP-C

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sashwati Roy

Must not be taking: Immunosuppressants

Disqualifiers: Marked immunodeficiency, Prisoners, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to heal chronic wounds and prevent them from reopening. Researchers are testing three treatments: Ceramiseal, a skin barrier cream called Epiceram, and Vaseline Petroleum Jelly. They seek to determine if certain skin moisture levels can predict whether a healed wound will reopen. Individuals who have had a wound heal in the past 10 days, which was open for at least 30 days (such as diabetic foot ulcers, pressure ulcers, or venous leg ulcers), may be suitable for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatments work in people and measuring their effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking wound care advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive medications for autoimmune diseases, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that EpiCeram is generally easy to use. This prescription cream helps repair and heal the skin by providing essential fats needed for healthy skin. Users of EpiCeram have reported few side effects, mostly mild ones like skin irritation.

The FDA has approved EpiCeram for treating dry skin and symptoms like burning and itching, indicating it has been tested for safety in similar uses.

In this study on wound healing, researchers are comparing EpiCeram to Vaseline Petroleum Jelly. Vaseline, a common over-the-counter product, is known for its safety and moisturizing properties.

Overall, both EpiCeram and Vaseline are considered safe and well-tolerated by most people, making them promising options in this wound healing study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic wounds because they might offer new ways to enhance skin healing. Ceramiseal and Epiceram, for example, are designed to strengthen the skin’s barrier function, potentially making them more effective at retaining moisture and protecting wounds compared to standard ointments like Vaseline. Ceramiseal uses a unique blend of lipids, mimicking natural skin composition, which could speed up the repair process. Epiceram, on the other hand, focuses on restoring the skin's natural barrier with a patented mix of ceramides, cholesterol, and free fatty acids, which could lead to improved healing outcomes. These innovative approaches could revolutionize how we manage chronic wounds by focusing on restoring the skin's natural defense systems.

What evidence suggests that this trial's treatments could be effective for chronic wounds?

Research shows that Epiceram, one of the treatments studied in this trial, effectively aids skin healing, which is crucial for treating long-lasting wounds. In past studies, Epiceram benefited patients as much as other treatments like Cutivate cream. The skin improved at a similar rate, although Cutivate cream acted slightly faster. Epiceram works by replenishing missing fats in the skin, which protects and repairs it. This suggests it might be effective for treating long-lasting wounds by promoting natural skin healing. Participants in this trial may receive either Epiceram or Vaseline Petroleum Jelly to evaluate their effectiveness in wound healing. ^{3 6 7 8 9}

Who Is on the Research Team?

Sashwati Roy, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults with chronic wounds open for at least 30 days, such as diabetic foot ulcers, pressure ulcers, venous leg ulcers, and burns. Participants must have adequate blood flow to the wound area and be willing to follow study procedures. Those with severe immunodeficiency, uncontrolled diabetes (HbA1c > 10%), allergies to petrolatum or currently in another research study are excluded.

Inclusion Criteria

You have a wound that has been open for at least 30 days, such as a diabetic foot ulcer, pressure ulcer, venous leg ulcer, burn wound, or another type of wound that the doctor thinks is appropriate for testing.

If your wound is almost healed, healed within the past 10 days, or if it's not safe to take a sample for testing, you cannot participate.

Age ≥ 18

Exclusion Criteria

Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent)

You have a weakened immune system due to conditions like HIV/AIDS, organ transplant, cancer, or autoimmune disease treated with immune-suppressing drugs.

If you have diabetes, your Hemoglobin A1c level is higher than 10%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EpiCeram or Vaseline Petroleum Jelly to assess TEWL at the wound site

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on wound closure and recurrence

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ceramiseal
• Epiceram Skin Barrier Function
• Vaseline Petroleum Jelly

Trial Overview The trial is testing two treatments: Epiceram Skin Barrier Function and Vaseline Petroleum Jelly on various chronic wounds. It aims to determine if high levels of water loss from a seemingly healed wound predict its likelihood of reopening.

How Is the Trial Designed?

Group I: TEWL - Epiceram Experimental Treatment 1 Intervention

Subjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site subjects

Group II: TEWL - Vaseline Petroleum Jelly Placebo Group 1 Intervention

Subjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site subjects

Who Is Running the Clinical Trial?

Sashwati Roy

Lead Sponsor

Trials

3

Recruited

390+

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04793711

EpiCeram for Skin Protection in Healthcare Workers EpiCeram Controlled Skin Barrier Emulsion (EpiCeram) is a prescription skin barrier repair product containing ingredients designed to improve skin barrier ...

2. liebertpub.com liebertpub.com/doi/10.1089/ten.teb.2019.0019

Healing of Chronic Wounds: An Update of Recent ... This review presents an overview of known wound healing mechanics, abnormalities that lead to chronic wounds, and a summary of established and new wound ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1089/ten.teb.2019.0019?icid=int.sj-abstract.similar-articles.2

Healing of Chronic Wounds: An Update of Recent ... ... Epiceram claims to restore barrier function of chronic and defectively closed wounds. The same trial is also testing Ceramiseal™, which is a similar ...

4. dermatologytimes.com dermatologytimes.com/view/creating-barrier-novel-therapy-replenishes-deficient-lipids

Creating a barrier: Novel therapy replenishes deficient lipids Results showed that the patients using Epiceram fared equally well as those using Cutivate cream, although the Cutivate cream cleared the skin symptoms faster.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932735/

Updates on Recent Clinical Assessment of Commercial ... This review is focused on evaluating the safety and efficacy outcomes of phase I to IV clinical trials for providing a statistically comprehensive understanding ...

6. accessdata.fda.gov accessdata.fda.gov/CDRH510K/K052643.pdf

APR ! 1 2006 - accessdata.fda.gov EPICERAM® helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Apply ...

7. epiceramrx.com epiceramrx.com/hcp.html

Healthcare Practitioners EpiCeram helps repair and heal the skin barrier through a unique delivery system not found in other products. EpiCeram contains 3 essential lipids– ceramides, ...

8. drugs.com drugs.com/cdi/epiceram-skin-barrier.html

EpiCeram Skin Barrier: Indications, Side Effects, Warnings Easy-to-read patient leaflet for EpiCeram Skin Barrier. Includes indications, proper use, special instructions, precautions, and possible ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf5/K052643.pdf

APR ! 1 2006 - accessdata.fda.gov EPICERAM® is a skin barrier emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of ...