Role of Tissue Oxygenation and the miR-210 Gene In Wound Healing
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 4/17/2018 |
| Start Date: | October 2014 |
| End Date: | January 2020 |
| Contact: | Amy Hoover, LPN |
| Email: | Amy.Hoover@osumc.edu |
| Phone: | (614) 293-0390 |
Tissue Oxygenation and miR-210 Role 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 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 are not infected and have been
open/not healed for at least 12 weeks, will be enrolled in this study. Patients will be
recruited from the OSU Wexner Medical Center 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; 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 to obtain information about the patient (age, sex,
race/ethnicity, current medications, TCOM, would location and type, other illness/diagnoses,
wound care treatment and instructions, nutritional status based on albumin levels), and at 14
weeks after enrollment to determine the final status of the wound (healed or not healed).
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.
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 are not infected and have been
open/not healed for at least 12 weeks, will be enrolled in this study. Patients will be
recruited from the OSU Wexner Medical Center 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; 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 to obtain information about the patient (age, sex,
race/ethnicity, current medications, TCOM, would location and type, other illness/diagnoses,
wound care treatment and instructions, nutritional status based on albumin levels), and at 14
weeks after enrollment to determine the final status of the wound (healed or not healed).
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.
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.
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.
Inclusion Criteria:
- Ages 30 + years
- Presence of 1 or more non-neuropathic venous stasis leg ulcer(s) (VLU) confirmed by
vascular duplex
- Wound size range >= 2 cm2
- Chronic - Wound open >4 weeks
Exclusion Criteria:
- Individuals who are deemed unable to understand the procedures, risks and benefits of
the study (i.e., informed consent) will be excluded
- Pregnant women
- Smokers
- Diabetes with hemoglobin A1C > 9%
- Subjects with marked immunodeficiency (i.e., patients with HIV/AIDS, organ transplant,
and/or cancer)
- Arterial disease (TCOM<30 mmHg or ABI < 0.6)
We found this trial at
2
sites
Columbus, Ohio 43205
Principal Investigator: Chandan K Sen, PhD
Phone: 614-366-2783
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Columbus, Ohio 43221
Principal Investigator: Chandan K Sen, PhD
Phone: 614-293-0390
Click here to add this to my saved trials