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Skin Barrier Function
Wound Healing Interventions for Chronic Wounds
Phase 4
Waitlist Available
Led By Gayle M Gordillo, M.D.
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
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.
Eligible Conditions
- Burns
- Chronic Wounds
- Foot Ulcer
- Pressure Sores
- Venous Leg Ulcer
- Chronic
- Wound
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biofilm Infection effects to TEWL at wound sites
Ceramiseal and EpiCeram restore barrier function to wounds in patients
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: High TEWL - Epiceram skin barrier functionExperimental Treatment1 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: High TEWL - CeramisealExperimental Treatment1 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
Group III: Low TEWLActive Control1 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 will be be discontinued from the study.
Group IV: High TEWL - No treatmentActive Control1 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 V: High TEWL - Vaseline Petroleum JellyPlacebo Group1 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
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
993 Previous Clinical Trials
1,095,018 Total Patients Enrolled
2 Trials studying Burns
68 Patients Enrolled for Burns
National Institute of Nursing Research (NINR)NIH
585 Previous Clinical Trials
10,379,049 Total Patients Enrolled
Gayle M Gordillo, M.D.Principal InvestigatorIndiana University
1 Previous Clinical Trials
45 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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