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Wound Healing Endpoint and Recurrence

NCT02577120 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-26

No results posted yet for this study

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

Interventions

DEVICE

Epiceram Skin Barrier Function

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

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.

Sponsors & Collaborators

  • Sashwati Roy

    lead OTHER

Principal Investigators

  • Sashwati Roy, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2029-02-28
Completion
2034-02-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577120 on ClinicalTrials.gov