Wound Healing Endpoint and Recurrence

NCT02577120 | Active Not Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: STUDY24010050
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

This study is a continuation of a previously approved protocol conducted at Ohio State University and Indiana University. The first two aims of the original protocol have been completed, and this protocol will finish enrollment for the third aim, comparing Hi TEWL and Low TEWL measurements, and whether a HiTEWLmeasurement indicates a seemingly healed wound is more likely to recur/reopen toa new wound. Of the 105 desired subjects, 62 subjects have already been recruited and completed their study participation at the previous university. 43 additional subjects will be recruited to complete the enrollment goal here at the University of Pittsburgh.

Conditions

Chronic Wound; Burn Wound; Diabetic Foot Ulcers; Pressure Ulcers; Venous Leg Ulcers; Chronic; Wound

Keywords

Epiceram

Outcome Measures

Primary Outcomes (1)

• TEWL

  If topical application of the FDA approved EpiCeram® restores barrier function (TEWL) 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.

  12 weeks

Study Arms (2)

TEWL - Epiceram

EXPERIMENTAL

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

TEWL - Vaseline Petroleum Jelly

PLACEBO COMPARATOR

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

Interventions

Epiceram Skin Barrier Function DEVICE

Epiceram is a non-sterile, viscous, lipid-rich emulsion

Also known as: Epiceram

TEWL - Epiceram

Vaseline Petroleum Jelly BIOLOGICAL

A skin protectant used for temporarily protecting minor cuts, scraps, burns, and helps to protect and help relieve chapped or cracked skin and lips.

Also known as: Petroleum

TEWL - Vaseline Petroleum Jelly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Willing to comply with protocol instructions, including all study visits and study activities.
• 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 least30 days, including:
• i. Diabetic foot ulcers, Wagner grade 1-3 ii. Pressure ulcers, stage 2-3 iii. Venous leg ulcers, confirmed by venous duplex iv. Burn wounds
• If candidate has a diabetic foot ulcer, ABI score measurement at Visit 1 must be between 0.7 and 1.2. If score is below or above, candidate will be considered a screen fail. Score can be gathered from EMR in previous 3 months to visit 1 if done as SOC or completed during visit 1.

You may not qualify if:

• Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent).
• 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 4pressure 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
• Patients with an HbA1c score greater than 10.0 at Visit 1, will be considered a screen fail. Score can be gathered from EMR in previous 12 months to visit 1 if done as SOC, or completed during visit 1.

Sponsors & Collaborators

• Sashwati Roy: lead

Study Sites (3)

University of Pittsburgh / McKeesport Clinic

Pittsburgh, Pennsylvania, 15132, United States

Location

University of Pittsburgh / Mercy Clinic

Pittsburgh, Pennsylvania, 15219, United States

Location

University of Pittsburgh / Passavant

Pittsburgh, Pennsylvania, 16066, United States

Location

Related Publications (21)

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• Barwell JR, Taylor M, Deacon J, Ghauri AS, Wakely C, Phillips LK, Whyman MR, Poskitt KR. Surgical correction of isolated superficial venous reflux reduces long-term recurrence rate in chronic venous leg ulcers. Eur J Vasc Endovasc Surg. 2000 Oct;20(4):363-8. doi: 10.1053/ejvs.2000.1196.

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• Disa JJ, Carlton JM, Goldberg NH. Efficacy of operative cure in pressure sore patients. Plast Reconstr Surg. 1992 Feb;89(2):272-8. doi: 10.1097/00006534-199202000-00012.

  PMID: 1732895 BACKGROUND

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• James GA, Swogger E, Wolcott R, Pulcini Ed, Secor P, Sestrich J, Costerton JW, Stewart PS. Biofilms in chronic wounds. Wound Repair Regen. 2008 Jan-Feb;16(1):37-44. doi: 10.1111/j.1524-475X.2007.00321.x. Epub 2007 Dec 13.

  PMID: 18086294 BACKGROUND

• Lavrijsen AP, Higounenc IM, Weerheim A, Oestmann E, Tuinenburg EE, Bodde HE, Ponec M. Validation of an in vivo extraction method for human stratum corneum ceramides. Arch Dermatol Res. 1994;286(8):495-503. doi: 10.1007/BF00371579.

  PMID: 7864665 BACKGROUND

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  PMID: 19054118 BACKGROUND

• Park SC, Choi CY, Ha YI, Yang HE. Utility of Toe-brachial Index for Diagnosis of Peripheral Artery Disease. Arch Plast Surg. 2012 May;39(3):227-31. doi: 10.5999/aps.2012.39.3.227. Epub 2012 May 10.

  PMID: 22783531 BACKGROUND

• Pinnagoda J, Tupker RA, Agner T, Serup J. Guidelines for transepidermal water loss (TEWL) measurement. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1990 Mar;22(3):164-78. doi: 10.1111/j.1600-0536.1990.tb01553.x.

  PMID: 2335090 BACKGROUND

• Romanos MT, Raspovic A, Perrin BM. The reliability of toe systolic pressure and the toe brachial index in patients with diabetes. J Foot Ankle Res. 2010 Dec 22;3:31. doi: 10.1186/1757-1146-3-31.

  PMID: 21176166 BACKGROUND

• Roy S, Elgharably H, Sinha M, Ganesh K, Chaney S, Mann E, Miller C, Khanna S, Bergdall VK, Powell HM, Cook CH, Gordillo GM, Wozniak DJ, Sen CK. Mixed-species biofilm compromises wound healing by disrupting epidermal barrier function. J Pathol. 2014 Aug;233(4):331-343. doi: 10.1002/path.4360. Epub 2014 May 27.

  PMID: 24771509 BACKGROUND

• Roy S, Patel D, Khanna S, Gordillo GM, Biswas S, Friedman A, Sen CK. Transcriptome-wide analysis of blood vessels laser captured from human skin and chronic wound-edge tissue. Proc Natl Acad Sci U S A. 2007 Sep 4;104(36):14472-7. doi: 10.1073/pnas.0706793104. Epub 2007 Aug 29.

  PMID: 17728400 BACKGROUND

• Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.

  PMID: 19903300 BACKGROUND

• Smack DP, Harrington AC, Dunn C, Howard RS, Szkutnik AJ, Krivda SJ, Caldwell JB, James WD. Infection and allergy incidence in ambulatory surgery patients using white petrolatum vs bacitracin ointment. A randomized controlled trial. JAMA. 1996 Sep 25;276(12):972-7.

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• Tetteh HA, Groth SS, Kast T, Whitson BA, Radosevich DM, Klopp AC, D'Cunha J, Maddaus MA, Andrade RS. Primary palmoplantar hyperhidrosis and thoracoscopic sympathectomy: a new objective assessment method. Ann Thorac Surg. 2009 Jan;87(1):267-74; discussion 274-5. doi: 10.1016/j.athoracsur.2008.10.028.

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• Thiele JJ, Traber MG, Packer L. Depletion of human stratum corneum vitamin E: an early and sensitive in vivo marker of UV induced photo-oxidation. J Invest Dermatol. 1998 May;110(5):756-61. doi: 10.1046/j.1523-1747.1998.00169.x.

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  PMID: 9129228 BACKGROUND

• FDA Wound Healing Clinical Focus Group.. Guidance for industry: chronic cutaneous ulcer and burn wounds-developing products for treatment. Wound Repair Regen. 2001 Jul-Aug;9(4):258-68. doi: 10.1046/j.1524-475x.2001.00258.x. No abstract available.

  PMID: 11679134 BACKGROUND

• Sen CK, Roy S, Mathew-Steiner SS, Gordillo GM. Biofilm Management in Wound Care. Plast Reconstr Surg. 2021 Aug 1;148(2):275e-288e. doi: 10.1097/PRS.0000000000008142.

  PMID: 34398099 DERIVED

MeSH Terms

Conditions

Burns; Diabetic Foot; Pressure Ulcer; Bronchiolitis Obliterans Syndrome; Wounds and Injuries

Interventions

Petroleum

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fossil Fuels; Complex Mixtures; Energy-Generating Resources; Environment; Environment and Public Health

Study Officials

• Sashwati Roy, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: October 16, 2015
• Study Start: January 8, 2019
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2034
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: January 8, 2019 - December 31, 2027
• Access Criteria: Data will be made available by the PI per Institution sharing policy and via published paper.

Locations

US (3)