NCT02577120Active, not recruitingPhase 1/2
Wound Healing Endpoint and Recurrence
Source: ClinicalTrials.gov · Last updated 26 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 26 Jun 2015
- Start date
- 8 Jan 2019
- Primary completion date
- Feb 2029
- Lead sponsor
- Sashwati Roy
- NCT number
- NCT02577120
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 100
- From 8 Jan 2019 to the primary completion date, Feb 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are currently enrolled in another research study which includes investigational treatment and/or medication
Other illness
- Subjects with marked immunodeficiency (HIV/AIDS, organ transplant patients and cancer patients and patients with autoimmune disease on immunosuppressive medications).
- Patients with allergies to petrolatum
Lab values
- 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.
Other
- Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent).
- 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
Who the study is looking for
- 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:
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pittsburgh / McKeesport Clinic Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| University of Pittsburgh / Mercy Clinic Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| University of Pittsburgh / Passavant Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.