Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02024243 |
| Other study ID # |
1901906845 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2015 |
| Est. completion date |
March 8, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Indiana University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The study is designed as 28-day prospective longitudinal observational study including a 98
day (14 week) follow-up photography of the wound to test whether wounds open on day 28 have
closed on week 14, or if they have remained chronically open.
On days 0, 14 and 28 after enrollment, wound images will be obtained. Wound photographs are a
part of standard care when patients come to the Comprehensive Wound Center (CWC). Images do
not include the part of body that could lead to identification of the participants. In
addition, following standard of care, two biopsies will be taken - one biopsy will be used
for laser capture microdissection (LCM) and immunohistochemistry studies, while the other
will be used for determination of infection status using quantitative bacterial cultures and
Scanning Electron Microscopy (SEM) imaging for biofilm phenotyping.
The following will be completed on days 0, 14 and 28:
1. Wound measurements - Photographs for digital planimetry to measure wound area.
2. Two Wound-edge biopsies (3mm) - following wound bed preparation with 1% lidocaine local
anesthetic, as required, two punch biopsies (3 mm each) will be obtained from the
wound-edge (the leading 3mm edge of the skin at the perimeter) of the same wound/ulcer.
3. Data Collection - the following information will be collected during the enrollment
visit and updated at each visit (weekly - on days 0, 7, 14, 21, 28 and 98 (week 14) ),
as necessary, and entered onto the data collection form: Age; Sex; Race/Ethnicity;
Current medications; Transcutaneous oxygen measurement(TCOM) <30 mmHg or ABI < 0.8;
Wound location & Etiology; Other associated illnesses; Wound care modality/treatment;
and Nutritional status will be recorded as documented by albumin levels and chart
records.
Healing outcome: Wound photography will be performed every 7 days (every week) as a part of
the current standard of care. Based on wound measurements from days 0 and 28 , patients will
be classified as either healing or non-healing, per criteria described in the study
proposal/protocol.
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 and 28.
