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NCT02577120 · ClinicalTrials.gov registry record · Phase 1
Wound Healing Endpoint and Recurrence
A Phase 1 study of Diabetic Foot Ulcers and Wound, sponsored by Sashwati Roy.
- Active
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 3
- Study locations
NCT02577120: Active Phase 1 study of Diabetic Foot Ulcers and Wound, sponsored by Sashwati Roy.
NCT02577120 is a Phase 1 study of Diabetic Foot Ulcers and Wound that is active but no longer recruiting, run by Sashwati Roy. The registered enrollment target is 100 participants, below the 226-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target (56% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02577120, a Phase 1 study of Diabetic Foot Ulcers and Wound, is active but no longer recruiting, sponsored by Sashwati Roy.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Epiceram Skin Barrier Function
- BIOLOGICAL Vaseline Petroleum Jelly
Study Locations (3)
Pennsylvania
- University of Pittsburgh / McKeesport Clinic - Pittsburgh
- University of Pittsburgh / Mercy Clinic - Pittsburgh
- University of Pittsburgh / Passavant - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2034-02 |
| Phase | Phase 1 |
What the registry record for NCT02577120 still lists
NCT02577120 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 226-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target (56% lower).
The record links to 7 conditions, with Diabetic Foot Ulcers appearing as the primary indexed condition, and to 2 interventions - of which Epiceram Skin Barrier Function is the first listed.
NCT02577120 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02577120 about?
NCT02577120 is a clinical study titled "Wound Healing Endpoint and Recurrence". 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 whet...
What is the current status of trial NCT02577120?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2019-01-08. Estimated completion is 2034-02.
What conditions does trial NCT02577120 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcers, Wound, Pressure Ulcers, Venous Leg Ulcers, Burn Wound.
What interventions are being tested in trial NCT02577120?
The interventions under investigation include: Epiceram Skin Barrier Function (DEVICE), Vaseline Petroleum Jelly (BIOLOGICAL).
Who is sponsoring clinical trial NCT02577120?
This trial is sponsored by Sashwati Roy, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02577120 being conducted?
This trial has 3 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02577120's enrollment target sits among peer trials
100 7th of 12 higher than 6 of 12 other Diabetic Foot Ulcers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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