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Trial record 2 of 2 for:    Varicose Veins | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Wound Healing Endpoint and Recurrence

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ClinicalTrials.gov Identifier: NCT02577120
Recruitment Status : Recruiting
First Posted : October 16, 2015
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Gayle Gordillo, Ohio State University

Brief Summary:
This prospective pilot study is to enroll patients with clinically-defined infected wounds. Patients enrolled in the study will be followed for 16 weeks for wound closure (Phase A), and will then begin Phase B. 265 clinically diagnosed infected burn or chronic wound patients will be recruited for this study in Phase A. Based on the expectation that 89% of these wounds will heal within 16 weeks of enrollment, 234 of these patients will continue with the study for Phase B.

Condition or disease Intervention/treatment
Chronic Wound Burn Wound Diabetic Foot Ulcers Pressure Ulcers Venous Leg Ulcers Chronic Wound Device: Epiceram Skin Barrier Function Biological: Vaseline Petroleum Jelly Biological: Ceramiseal

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 265 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wound Healing Endpoint and Recurrence
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Petroleum

Group/Cohort Intervention/treatment
Low TEWL
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.
High TEWL - No treatment
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
High TEWL - Epiceram skin barrier function
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
Device: Epiceram Skin Barrier Function
Epiceram is a non-sterile, viscous, lipid-rich emulsion
Other Name: Epiceram

High TEWL - Ceramiseal
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
Biological: Ceramiseal
Topical serum designed to fortify delicate skin with essential lipids. The proprietary blend of naturally occurring lipids contained in Ceramiseal are designed to improve the barrier function of your skin's outer layer; thereby restoring critical moisture balance and improving physical appearance and function.
Other Name: Skin Barrier Function

High TEWL - Vaseline Petroleum Jelly
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
Biological: Vaseline Petroleum Jelly
A skin protectant used for temporarily protecting minor cuts, scraps, burns, and helps to protect and help relieve chapped or cracked skin and lips.
Other Name: Petroleum




Primary Outcome Measures :
  1. Biofilm Infection effects to TEWL at wound sites [ Time Frame: 12 weeks ]
    If a history of wound biofilm infection results in elevated TEWL at wound sites that appear closed, defectively closed wounds featuring high TEWL show higher "recurrence rate" than functionally closed wounds with low TEWL. This will be identified by how many subjects with a high TEWL reading and biofilm infection, have recurrence of their wound versus subjects with a low TEWL reading.

  2. Ceramiseal and EpiCeram restore barrier function to wounds in patients [ Time Frame: 12 weeks ]
    If topical application of the Ceramiseal™ or the FDA approved EpiCeram® restores barrier function to defectively closed wounds. These will be compared to a Placebo cream, Vaseline and will be seen after 3 months of application to the wound site.


Biospecimen Retention:   Samples With DNA
Tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
265 clinically diagnosed infected burn or chronic wound patients
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Willing to comply with protocol instructions, including all biopsies, study visits and study activities.
  • One of the following:

    1. Chronic wound of multiple etiologies and open for at least 30 days, including:

      1. Diabetic foot ulcers, Wagner grade 1-3
      2. Pressure ulcers, stage 2-3
      3. Venous leg ulcers, confirmed by venous duplex
      4. Burn wounds open
      5. Clinical contraindication to biopsy in the opinion of the wound care physician
    2. Wounds not appropriate for biopsy due to either:

      1. Almost healed at the time of enrollment (per physician)
      2. Healed within 10 days prior to enrollment visit
      3. Other etiology, deemed appropriate for biopsy
  • Adequate arterial blood flow as evidenced by at least one of the following:

    1. Transcutaneous oxygen measurement (TcOM) > 30 mmHg
    2. Ankle-brachial index ≥0.7
    3. Toe pressure > 30 mmHg

Exclusion Criteria:

  • Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent)
  • Diabetics with Hemoglobin A1c > 10%
  • Subjects with marked immunodeficiency (HIV/AIDS, organ transplant patients and cancer patients and patients with autoimmune disease on immunosuppressive medications).
  • Wounds closed or to be closed by flap or graft coverage - including stage 4 pressure ulcers 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 includes investigational treatment and/or medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577120


Contacts
Contact: Amy Hoover, LPN 614-293-0390 Amy.Hoover@osumc.edu

Locations
United States, Ohio
OSU Hospital East Recruiting
Columbus, Ohio, United States, 43203
Contact: Amy Hoover, LPN    614-366-2783    Amy.Hoover@osumc.edu   
Martha Morehouse Medical Plaza Recruiting
Columbus, Ohio, United States, 43210
Contact: Amy Hoover, LPN    614-293-0390    Amy.Hoover@osumc.edu   
Sponsors and Collaborators
Ohio State University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Gayle M Gordillo, M.D. Ohio State University

Publications:

Responsible Party: Gayle Gordillo, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02577120     History of Changes
Other Study ID Numbers: 2015H0116
RFA-NR-15-001 ( Other Grant/Funding Number: NINR )
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: April 2017

Keywords provided by Gayle Gordillo, Ohio State University:
Epiceram
Ceramiseal

Additional relevant MeSH terms:
Varicose Ulcer
Varicose Veins
Wounds and Injuries
Ulcer
Recurrence
Diabetic Foot
Foot Ulcer
Leg Ulcer
Pressure Ulcer
Pathologic Processes
Disease Attributes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Petrolatum
Decanoic acid
Emollients
Dermatologic Agents
Antifungal Agents
Anti-Infective Agents