Role of Tissue Oxygenation and the miR-210 Gene In Wound Healing

NCT02024243 | Terminated

• 1 other identifier: 1901906845
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Non-Diabetic Patients; Wound Leg; Chronic Ulcer Leg/Foot

Keywords

Micro RNA; Wound; Chronic Venous Leg Ulcer; VLU; miR210; Indiana University Health Comprehensive Wound Center (CWC)

Outcome Measures

Primary Outcomes (1)

• Mean Change of miR210 Expression Across Healing Status (Healing vs. Non-Healing)

  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.

  28 Days

Study Arms (1)

Venous leg ulcers

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.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

non-diabetic or controlled diabetic, chronic (open \>4 weeks) Venous leg ulcers

You may qualify if:

• Ages 30 + years
• Presence of 1 or more non-neuropathic venous stasis leg ulcer(s) (VLU) confirmed by vascular duplex
• Chronic - Wound open \>4 weeks

You may not qualify if:

• Individuals who are deemed unable to understand the procedures, risks, and benefits of the study (i.e., informed consent) will be excluded
• Pregnant women
• Diabetes with hemoglobin A1C \> 9%
• Subjects with marked immunodeficiency (i.e., patients with HIV/AIDS, organ transplant, and/or cancer)
• Inadequate arterial supply, as evidenced by any of the following (for subjects receiving tissue biopsy with wounds below the knee):
• TcOM \< 30mmHg
• ABI \< 0.7 or \>1.20
• TBI \< 0.6

Sponsors & Collaborators

• Chandan Sen: lead

Study Sites (3)

Indiana University Health Comprehensive Wound Center

Indianapolis, Indiana, 46202, United States

Location

OSUWMC Comprehensive Wound Center (University Hospital East)

Columbus, Ohio, 43205, United States

Location

OSUWMC Comprehensive Would Center (Martha Morehouse Medical Plaza)

Columbus, Ohio, 43221, United States

Location

Related Links

• IU Department of Surgery
• Indiana Center for Regenerative Medicine and Engineering

Biospecimen

Retention: SAMPLES WITH DNA

wound tissue biopsies

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Chandan K Sen, PhD

  Indiana University Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 31, 2013
• Study Start: October 1, 2015
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (3)