Non-Diabetic PatientsmiR210NCT02024243
Role of Tissue Oxygenation and the miR-210 Gene In Wound Healing
An observational study of Non-Diabetic Patients and Wound Leg, run by Chandan Sen at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Diabetic Patients, Wound Leg, Chronic Ulcer Leg/Foot
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2015to 8 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: non-diabetic or controlled diabetic, chronic (open >4 weeks) Venous leg ulcers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
OSUWMC Comprehensive Wound Center (University Hospital East)
Columbus, Ohio, 43205
OSUWMC Comprehensive Would Center (Martha Morehouse Medical Plaza)
Columbus, Ohio, 43221
Indiana University Health Comprehensive Wound Center
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read more
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.
Read the detailed 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:
- Wound measurements - Photographs for digital planimetry to measure wound area.
- 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.
- 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.
- 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)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study start1 Oct 2015
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Why it stopped: No funding available to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Diabetic PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chandan Sen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chandan Sen, Indiana University
- Investigators
- Chandan K Sen, PhD, Principal investigator, Indiana University Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024243
- Sponsor's protocol ID
- 1901906845
- Acronym
- miR210
- Status last verified
- Apr 2024
- First submitted
- 19 Dec 2013
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Oxygenation and miR-210 Role In Wound Healing
- ClinicalTrials.gov ID
- NCT02024243
- Acronym / sponsor ID
- miR210 / 1901906845
- 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)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No funding available to continue
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chandan SenUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Wound measurements - Photographs for digital planimetry to measure wound area.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- non-diabetic or controlled diabetic, chronic (open >4 weeks) Venous leg ulcers
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Change of miR210 Expression Across Healing Status (Healing vs. Non-Healing)
Time frame: 28 Days
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.
Results and safety
The study was stopped early (reason given: No funding available to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- IU Department of SurgeryLink provided by the sponsor.
- Indiana Center for Regenerative Medicine and EngineeringLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandan K Sen, PhD principal investigator
Indiana University Department of Surgery
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Diabetic Patients and Wound Leg, run by Chandan Sen at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No funding available to continue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change of miR210 Expression Across Healing Status (Healing vs. Non-Healing) (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.