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miR210 and Punch Tissue Biopsy for Chronic Venous Leg Ulcers (miR210 Trial)

N/A
Waitlist Available
Led By Chandan K Sen, PhD
Research Sponsored by Chandan Sen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Summary

This trial will help researchers understand if 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.

Eligible Conditions
  • Leg Wound
  • Chronic Venous Leg Ulcers
  • Non-Diabetic Patients

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change of miR210 Expression Across Healing Status (Healing vs. Non-Healing)

Trial Design

1Treatment groups
Experimental Treatment
Group I: miR210 and Punch Tissue BiopsyExperimental Treatment1 Intervention
Patients visiting the Indiana University Health Comprehensive Wound Center, with a chronic venous leg ulcer(s), who qualify based on the study inclusion and exclusion criteria, will be involved in a 14-week (98 days) longitudinal observational study. All subjects in this arm will have wound measurements, photographs for digital planimetry to measure wound area, and two 3 mm punch tissue biopsies of the same wound/ulcer (for OCT & infection) on days day 0, 14, and 28. Biopsies will not be taken if the wound has closed by day 14 or 28. Patient charts will be reviewed 98 days (14 weeks) after enrollment to determine the final status of the wound as healed or not-healed.

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Who is running the clinical trial?

Chandan SenLead Sponsor
1 Previous Clinical Trials
256 Total Patients Enrolled
Chandan K Sen, PhDPrincipal InvestigatorIndiana University Department of Surgery
8 Previous Clinical Trials
1,461 Total Patients Enrolled
~5 spots leftby Sep 2025
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