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NCT02024243 · ClinicalTrials.gov registry record
Role of Tissue Oxygenation and the miR-210 Gene In Wound Healing
A clinical trial, sponsored by Chandan Sen.
- Terminated
- Registry status
- 54
- Enrollment target
NCT02024243: Clinical Trial study, sponsored by Chandan Sen.
NCT02024243 is a clinical trial that was terminated before completion, run by Chandan Sen. The registered enrollment target is 54 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02024243 was terminated before completion, sponsored by Chandan Sen.
- TERMINATED
- Registry status
- 54 participants
- Enrollment target
Study Summary
Hypothesis: Elevated miR210 in the epidermis (outer layer of skin) of ischemic human wound edge tissue (tissue that has a lack of blood flow to it) is associated with poor healing outcome in a setting of standard clinical care. Aim of the study: To determine whether elevated miR-210 in the epidermis of ischemic human wound edge tissue is associated with poor healing outcome in a setting of standard clinical care. This study will last 14 weeks. Adult patients, who are non-diabetic or tightly controlled diabetic, and, who have chronic venous leg ulcers that have been open/not healed for at least 12 weeks, will be enrolled in this study. Patients will be recruited from the Indiana University Health Comprehensive Wound Center (CWC). On days 0, 14 and 28, patients will have the following performed: measurements and photographs taken of their wound; TCOM (transcutaneous oxygen measurement) or ABI to measure the amount of oxygen in the wound tissue, if receiving a tissue biopsy; and two 3-mm punch biopsies from the same wound/ulcer. Biopsies will not be taken if the wound has closed by day 14 or day 28. Additionally, patients' medical records will be reviewed throughout the study for 98 days (14 weeks) after enrollment to determine the final status of the wound as healed or not-healed. ABI will be completed per study personnel at initial visit for all consented subjects to ensure subject eligibility (as listed TCOM\<30 mmHg in exclusion criteria). If ABI's are unable to be obtained, TCOM will be performed. There will be a total of 5 visits for this study (6 total visits for patients with open wounds on day 28 of the study). Visits will occur on days 0, 7, 14, 21,28.
Primary Outcome
The primary analysis will compare mean change cycle times (Delta Ct) of the baseline (d1) miR-210 expression across wound healing status (i.e., healing vs non-healing based on d28/d0 wound size (%) using either the two-sample t-test or the non-parametric Wilcoxon rank-sum test depending on the distribution of miR-210 and the homogeneity of the variance across groups.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-10-01 |
| Est. Completion | 2023-03-08 |
Why NCT02024243 stopped before completion
NCT02024243 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 54 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02024243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02024243 about?
NCT02024243 is a clinical study titled "Role of Tissue Oxygenation and the miR-210 Gene In Wound Healing". Hypothesis: Elevated miR210 in the epidermis (outer layer of skin) of ischemic human wound edge tissue (tissue that has a lack of blood flow to it) is associated with poor healing outcome in a setting of standard clinical care. Aim of the study: To determine whether elevated miR-210 in the epidermi...
What is the current status of trial NCT02024243?
This trial is currently terminated. The enrollment target is 54 participants. The study started on 2015-10-01. Estimated completion is 2023-03-08.
Who is sponsoring clinical trial NCT02024243?
This trial is sponsored by Chandan Sen, which has 2 total clinical trials registered on ClinicalTrials.gov.
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