Phase
Condition
Venous Leg Ulcers
Diabetic Foot Ulcers
Pressure Ulcers
Treatment
Epiceram Skin Barrier Function
Vaseline Petroleum Jelly
Ceramiseal
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18
Willing to comply with protocol instructions, including all study visits and studyactivities.
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 least30days, including: i. Diabetic foot ulcers, Wagner grade 1-3 ii. Pressure ulcers, stage 2-3 iii. Venousleg ulcers, confirmed by venous duplex iv. Burn wounds
If candidate has a diabetic foot ulcer, ABI score measurement at Visit 1 must bebetween 0.7 and 1.2. If score is below or above, candidate will be considered ascreen fail. Score can be gathered from EMR in previous 3 months to visit 1 if doneas SOC or completed during visit 1.
Exclusion
Exclusion Criteria:
Individuals who are deemed unable to understand the procedures, risks and benefitsof the study, (i.e. unable to provide informed consent).
Subjects with marked immunodeficiency (HIV/AIDS, organ transplant patients andcancer patients and patients with autoimmune disease on immunosuppressivemedications).
Wounds closed or to be closed by flap or graft coverage - including stage 4pressureulcers and Wagner grade 4 or 5 diabetic foot ulcers.
Prisoners
Patients with allergies to petrolatum
Patients who are currently enrolled in another research study which includesinvestigational treatment and/or medication
Patients with an HbA1c score greater than 10.0 at Visit 1, will be considered ascreen fail. Score can be gathered from EMR in previous 12 months to visit 1 if doneas SOC, or completed during visit 1.
Study Design
Study Description
Connect with a study center
IU Health Methodist Hospital
Indianapolis, Indiana 46202
United StatesSite Not Available
Martha Morehouse Medical Plaza
Columbus, Ohio 43210
United StatesSite Not Available
University of Pittsburgh / McKeesport Clinic
Pittsburgh, Pennsylvania 15132
United StatesSite Not Available
University of Pittsburgh / Mercy Clinic
Pittsburgh, Pennsylvania 15219
United StatesSite Not Available
University of Pittsburgh / Passavant
Pittsburgh, Pennsylvania 16066
United StatesSite Not Available
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