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Wound Healing Interventions for Chronic Wounds
Study Summary
This trial studies wound healing in 265 patients with infected burns or chronic wounds; 89% will heal in 16 weeks, and 234 continue for further study.
- Burns
- Chronic Wounds
- Foot Ulcer
- Pressure Sores
- Venous Leg Ulcer
- Chronic
- Wound
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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%.You are allergic to petrolatum.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.You have wounds that require or have had surgery to close them, such as severe pressure ulcers or diabetic foot ulcers.You have good blood flow in the arteries of your body, as shown by specific measurements.
- Group 1: High TEWL - Epiceram skin barrier function
- Group 2: High TEWL - Ceramiseal
- Group 3: High TEWL - Vaseline Petroleum Jelly
- Group 4: Low TEWL
- Group 5: High TEWL - No treatment
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this experiment have any vacancies for participants?
"Clinicaltrials.gov reports that this clinical trial is presently looking for subjects, having initially been posted on the 9th of January 2019 and most recently updated on the 11th of May 2023."
Has the FDA granted authorization for High TEWL - Epiceram to be used as a skin barrier?
"There is ample clinical data affirming the safety of High TEWL - Epiceram skin barrier function, earning it a score of 3. As this treatment has been approved and released to the market, Phase 4 trials are being conducted."
For what conditions is High TEWL - Epiceram skin barrier function employed therapeutically?
"Epiceram is often prescribed for the relief of dry eye syndrome and other related condtions such as pruritus ani, irritated skin, and throat infection. This drug works to improve TEWL (transepidermal water loss) which helps restore a healthy epidermis."
Have other studies been conducted to analyze the efficacy of High TEWL - Epiceram as a skin barrier?
"Currently, there are 10 active investigations into High TEWL - Epiceram skin barrier function with none in Phase 3. Of these trials, the majority of them are underway at locations around Boston, Massachusetts; however, 16 other places across the United States also have studies running for this purpose."
Could you provide an approximate figure for the number of participants in this clinical experiment?
"Affirmative. The clinicaltrials.gov database advertises that this medical trial is actively recruiting participants, having been initially posted on September 1st 2019 and last revised on May 11th 2023. A total of 265 patients need to be enlisted from a single research centre."
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