Diabetes MellitusNCT02581098
miR-200b & miR-21 in Diabetic Wounds
An observational study of Diabetes Mellitus and Foot Ulcer, run by Indiana University at 4 sites in United States.
Trial summary
This study aims to determine if elevated wound-edge endothelial miR-200b is a barrier to wound healing in diabetic patients and also to determine if ex vivo supplementation of miR-21 mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from NPWT sponges from diabetic wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Foot Ulcer, Ulcer
- How many people
- 98 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2015to 26 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 124 subjects with diabetic foot ulcers who have wound tissue oxygenation adequate to support wound healing
Who may be able to join
- Ages 18 and older
- Willing and able to provide informed consent
- Willing and able to comply with protocol instructions, including all biopsies and study visits
- Diabetes Mellitus
- Chronic wounds (open >30d) of any etiology
- Subjects with Negative Pressure Wound Therapy (NPWT or also called a wound vac) (Note: Applies only to the miR-21 arm)
Who cannot join
- Revascularization surgery on the target wound within 60 days prior to enrollment
- Inadequate arterial supply, as evidenced by any of the following:
- Transcutaneous Oxygen Measurement (TcOM) < 30mmg
- Ankle Brachial Index (ABI) <0.7 or 1.3
- Toe Brachial Index (TBI) <0.6
- Subjects with marked immunodeficiency (HIV/AIDS, organ transplant patients and actively being treated for cancer)
Show all 9Show fewer
- Trauma wounds
- Wounds closed or to be closed by flap or graft coverage
- Women who are pregnant
Trial locations and contacts
4 sites in 1 country.
United States4 sites
OSU Hospital East
Columbus, Ohio, 43205
Davis Heart and Lung Research Institute
Columbus, Ohio, 43210
Martha Morehouse Medical Plaza
Columbus, Ohio, 43221
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Novel Regulators of Wound Angiogenesis and Inflammation
This study aims to determine if elevated wound-edge endothelial miR-200b is a barrier to wound healing in diabetic patients and also to determine if ex vivo supplementation of miR-21 mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from NPWT sponges from diabetic wounds. This study will enroll 124 (60 in the miR-200b arm and 64 in the miR21 arm) Diabetic Wound patients who have wound tissue oxygenation adequate to support wound healing and will be in the study for 14 weeks that includes 4 study visits.
Read the detailed description
The study is designed as a 14 week prospective observational study where patients with diabetic wounds visiting the Indiana University Health Comprehensive Wound Center (CWC) will be enrolled. Patients enrolled will be followed for 14 weeks including 4 study visits, initial visit (week 0), study visit 2 (week 2), study visit 3 (week 4), and will return for a final follow-up study visit 4 (week 14; miR-200b arm only). Standardized Care Outline will be per physician discretion.
The initial visit will take place during the patients regularly scheduled CWC visit and the following will take place: informed consent will be obtained, baseline demographics and medical history with be collected, current labs and medications will be recorded, wound data will be obtained, an ankle brachial index will be completed for patients with leg wounds below the knee, if not already completed per Standard of Care (SoC) since onset of the wound, and wound photographs for digital planimetry to measure wound area. Wound fluid will be collected using a filter paper method, aspiration method, or via the NPWT (Negative Pressure Wound Therapy, also known as Wound Vac) sponge prior to debridement. Additionally, two 3 mm punch tissue biopsies will be obtained from the patient's physician; however, this is optional. If the wound shows signs of healing and does not show signs of infection (i.e. the wound has not stalled in healing for 2 or more weeks or become larger in size) or the wound has been declared healed by their physician, the biopsies will not be obtained. The study visits 2-4 will include the following: a medication and adverse event review, wound data will be recorded, wound photographs, wound fluid, and two 3 mm punch tissue biopsies will be obtained from the patient's physician.
Potential Risks:
The risks associated with this research study are low. There are no therapeutic interventions or medications as part of this study to be administered depending on the amount of sensation the subject has at the site of the wound.
If the subject is receiving a biopsy, the wound site will be numbed by applying local anesthesia as appropriate to the area being biopsied. There may be some discomfort with the tissue biopsy procedure, but all reasonable efforts will be made to minimize pain. The biopsy procedure is done within the boundaries of the existing wound to avoid giving the patient a separate new wound. Bleeding is a possible complication, but the risk is low for the small biopsies and is reduced by using local anesthetics with epinephrine, and silver nitrate sticks are available in each room to cauterize biopsy sites as needed. Infection is also a potential risk; however, wound tissue biopsies are routinely performed as the standard of care in the CWC to diagnose wound infection. The biopsy site will be appropriately monitored for infection by the physician managing the wound during routine wound clinic visits.
The ABI test may result in temporary discomfort around the ankle or foot when the cuff is inflated, but does not present any further physical or medical risks. The wound fluid collection is non-invasive and does not present any risk. Study participants will not benefit directly from participation in this study. This research information has the potential of providing considerable benefits to wound care by identifying a key player that influences the closure of chronic diabetic wounds. Such knowledge should help develop novel biomarker and or miR-directed therapeutic strategies.
- Conditions
- Diabetes Mellitus, Foot Ulcer, Ulcer, Diabetic Foot Ulcer, Wound, Wound Heal
- Being tested
- No interventions
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer, Ulcer, Diabetic Foot, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound-edge endothelial miR-200b
This study aims to determine if elevated wound-edge endothelial miR-200b and attenuated wound macrophage miR-21 levels are barriers to wound healing (closure) in diabetic wounds.
Measured: 14 weeks
Wound macrophage isolation to determine miR-21
To determine if ex vivo supplementation of miR-21 mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from Negative Pressure Wound Therapy sponges from diabetic wounds.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startAug 2015
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Chandan Sen, Indiana University
- Investigators
- Chandan K Sen, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581098
- Sponsor's protocol ID
- 1807426080
- Other IDs
- GM108014/DK114718
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2015
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan YC, Khanna S, Roy S, Sen CK. miR-200b targets Ets-1 and is down-regulated by hypoxia to induce angiogenic response of endothelial cells. J Biol Chem. 2011 Jan 21;286(3):2047-56. doi: 10.1074/jbc.M110.158790. Epub 2010 Nov 16.
PubMed 21081489Chan YC, Roy S, Khanna S, Sen CK. Downregulation of endothelial microRNA-200b supports cutaneous wound angiogenesis by desilencing GATA binding protein 2 and vascular endothelial growth factor receptor 2. Arterioscler Thromb Vasc Biol. 2012 Jun;32(6):1372-82. doi: 10.1161/ATVBAHA.112.248583. Epub 2012 Apr 12.
PubMed 22499991Chin D, Boyle GM, Theile DR, Parsons PG, Coman WB. The human genome and gene expression profiling. J Plast Reconstr Aesthet Surg. 2006;59(9):902-11. doi: 10.1016/j.bjps.2006.01.008. Epub 2006 Mar 9.
PubMed 16920579Gardner SE, Frantz RA, Doebbeling BN. The validity of the clinical signs and symptoms used to identify localized chronic wound infection. Wound Repair Regen. 2001 May-Jun;9(3):178-86. doi: 10.1046/j.1524-475x.2001.00178.x.
PubMed 11472613Parsek MR, Singh PK. Bacterial biofilms: an emerging link to disease pathogenesis. Annu Rev Microbiol. 2003;57:677-701. doi: 10.1146/annurev.micro.57.030502.090720.
PubMed 14527295Roy S, Khanna S, Rink C, Biswas S, Sen CK. Characterization of the acute temporal changes in excisional murine cutaneous wound inflammation by screening of the wound-edge transcriptome. Physiol Genomics. 2008 Jul 15;34(2):162-84. doi: 10.1152/physiolgenomics.00045.2008. Epub 2008 May 6.
PubMed 18460641Roy S, Patel D, Khanna S, Gordillo GM, Biswas S, Friedman A, Sen CK. Transcriptome-wide analysis of blood vessels laser captured from human skin and chronic wound-edge tissue. Proc Natl Acad Sci U S A. 2007 Sep 4;104(36):14472-7. doi: 10.1073/pnas.0706793104. Epub 2007 Aug 29.
PubMed 17728400Schafer M, Werner S. Transcriptional control of wound repair. Annu Rev Cell Dev Biol. 2007;23:69-92. doi: 10.1146/annurev.cellbio.23.090506.123609.
PubMed 17474876Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.
PubMed 19903300Shilo S, Roy S, Khanna S, Sen CK. Evidence for the involvement of miRNA in redox regulated angiogenic response of human microvascular endothelial cells. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):471-7. doi: 10.1161/ATVBAHA.107.160655. Epub 2008 Feb 7.
PubMed 18258815Shilo S, Roy S, Khanna S, Sen CK. MicroRNA in cutaneous wound healing: a new paradigm. DNA Cell Biol. 2007 Apr;26(4):227-37. doi: 10.1089/dna.2006.0568.
PubMed 17465889Hopf HW, Ueno C, Aslam R, Burnand K, Fife C, Grant L, Holloway A, Iafrati MD, Mani R, Misare B, Rosen N, Shapshak D, Benjamin Slade J Jr, West J, Barbul A. Guidelines for the treatment of arterial insufficiency ulcers. Wound Repair Regen. 2006 Nov-Dec;14(6):693-710. doi: 10.1111/j.1524-475X.2006.00177.x. No abstract available.
PubMed 17199834Padberg FT, Back TL, Thompson PN, Hobson RW 2nd. Transcutaneous oxygen (TcPO2) estimates probability of healing in the ischemic extremity. J Surg Res. 1996 Feb 1;60(2):365-9. doi: 10.1006/jsre.1996.0059.
PubMed 8598670Wutschert R, Bounameaux H. Determination of amputation level in ischemic limbs. Reappraisal of the measurement of TcPo2. Diabetes Care. 1997 Aug;20(8):1315-8. doi: 10.2337/diacare.20.8.1315.
PubMed 9250461
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
- Novel Regulators of Wound Angiogenesis and Inflammation
- ClinicalTrials.gov ID
- NCT02581098
- Acronym / sponsor ID
- 1807426080
- Conditions
- Diabetes Mellitus, Foot Ulcer, Ulcer, Diabetic Foot Ulcer, Wound, Wound Heal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2015 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 20 Oct 2015 (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.
This study aims to determine if elevated wound-edge endothelial miR-200b is a barrier to wound healing in diabetic patients and also to determine if ex vivo supplementation of miR-21 mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from NPWT sponges from diabetic wounds. This study will enroll 124 (60 in the miR-200b arm and 64 in the miR21 arm) Diabetic Wound patients who have wound tissue oxygenation adequate to support wound healing and will be in the study for 14 weeks that includes 4 study visits.
Detailed description
The study is designed as a 14 week prospective observational study where patients with diabetic wounds visiting the Indiana University Health Comprehensive Wound Center (CWC) will be enrolled. Patients enrolled will be followed for 14 weeks including 4 study visits, initial visit (week 0), study visit 2 (week 2), study visit 3 (week 4), and will return for a final follow-up study visit 4 (week 14; miR-200b arm only). Standardized Care Outline will be per physician discretion.
The initial visit will take place during the patients regularly scheduled CWC visit and the following will take place: informed consent will be obtained, baseline demographics and medical history with be collected, current labs and medications will be recorded, wound data will be obtained, an ankle brachial index will be completed for patients with leg wounds below the knee, if not already completed per Standard of Care (SoC) since onset of the wound, and wound photographs for digital planimetry to measure wound area. Wound fluid will be collected using a filter paper method, aspiration method, or via the NPWT (Negative Pressure Wound Therapy, also known as Wound Vac) sponge prior to debridement. Additionally, two 3 mm punch tissue biopsies will be obtained from the patient's physician; however, this is optional. If the wound shows signs of healing and does not show signs of infection (i.e. the wound has not stalled in healing for 2 or more weeks or become larger in size) or the wound has been declared healed by their physician, the biopsies will not be obtained. The study visits 2-4 will include the following: a medication and adverse event review, wound data will be recorded, wound photographs, wound fluid, and two 3 mm punch tissue biopsies will be obtained from the patient's physician.
Potential Risks:
The risks associated with this research study are low. There are no therapeutic interventions or medications as part of this study to be administered depending on the amount of sensation the subject has at the site of the wound.
If the subject is receiving a biopsy, the wound site will be numbed by applying local anesthesia as appropriate to the area being biopsied. There may be some discomfort with the tissue biopsy procedure, but all reasonable efforts will be made to minimize pain. The biopsy procedure is done within the boundaries of the existing wound to avoid giving the patient a separate new wound. Bleeding is a possible complication, but the risk is low for the small biopsies and is reduced by using local anesthetics with epinephrine, and silver nitrate sticks are available in each room to cauterize biopsy sites as needed. Infection is also a potential risk; however, wound tissue biopsies are routinely performed as the standard of care in the CWC to diagnose wound infection. The biopsy site will be appropriately monitored for infection by the physician managing the wound during routine wound clinic visits.
The ABI test may result in temporary discomfort around the ankle or foot when the cuff is inflated, but does not present any further physical or medical risks. The wound fluid collection is non-invasive and does not present any risk. Study participants will not benefit directly from participation in this study. This research information has the potential of providing considerable benefits to wound care by identifying a key player that influences the closure of chronic diabetic wounds. Such knowledge should help develop novel biomarker and or miR-directed therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 124 subjects with diabetic foot ulcers who have wound tissue oxygenation adequate to support wound healing
Key inclusion criteria (6 listed)
- Ages 18 and older
- Willing and able to provide informed consent
- Willing and able to comply with protocol instructions, including all biopsies and study visits
- Diabetes Mellitus
- Chronic wounds (open >30d) of any etiology
Key exclusion criteria (9 listed)
- Revascularization surgery on the target wound within 60 days prior to enrollment
- Inadequate arterial supply, as evidenced by any of the following:
- Transcutaneous Oxygen Measurement (TcOM) < 30mmg
- Ankle Brachial Index (ABI) <0.7 or 1.3
- Toe Brachial Index (TBI) <0.6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsNo interventions | Other | – |
Primary outcome
Wound-edge endothelial miR-200b
Time frame: 14 weeks
This study aims to determine if elevated wound-edge endothelial miR-200b and attenuated wound macrophage miR-21 levels are barriers to wound healing (closure) in diabetic wounds.
Wound macrophage isolation to determine miR-21
Time frame: 14 weeks
To determine if ex vivo supplementation of miR-21 mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from Negative Pressure Wound Therapy sponges from diabetic wounds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 21081489Chan YC, Khanna S, Roy S, Sen CK. miR-200b targets Ets-1 and is down-regulated by hypoxia to induce angiogenic response of endothelial cells. J Biol Chem. 2011 Jan 21;286(3):2047-56. doi: 10.1074/jbc.M110.158790. Epub 2010 Nov 16.
- Background: PubMed 22499991Chan YC, Roy S, Khanna S, Sen CK. Downregulation of endothelial microRNA-200b supports cutaneous wound angiogenesis by desilencing GATA binding protein 2 and vascular endothelial growth factor receptor 2. Arterioscler Thromb Vasc Biol. 2012 Jun;32(6):1372-82. doi: 10.1161/ATVBAHA.112.248583. Epub 2012 Apr 12.
- Background: PubMed 16920579Chin D, Boyle GM, Theile DR, Parsons PG, Coman WB. The human genome and gene expression profiling. J Plast Reconstr Aesthet Surg. 2006;59(9):902-11. doi: 10.1016/j.bjps.2006.01.008. Epub 2006 Mar 9.
- Background: PubMed 11472613Gardner SE, Frantz RA, Doebbeling BN. The validity of the clinical signs and symptoms used to identify localized chronic wound infection. Wound Repair Regen. 2001 May-Jun;9(3):178-86. doi: 10.1046/j.1524-475x.2001.00178.x.
- Background: PubMed 14527295Parsek MR, Singh PK. Bacterial biofilms: an emerging link to disease pathogenesis. Annu Rev Microbiol. 2003;57:677-701. doi: 10.1146/annurev.micro.57.030502.090720.
- Background: PubMed 18460641Roy S, Khanna S, Rink C, Biswas S, Sen CK. Characterization of the acute temporal changes in excisional murine cutaneous wound inflammation by screening of the wound-edge transcriptome. Physiol Genomics. 2008 Jul 15;34(2):162-84. doi: 10.1152/physiolgenomics.00045.2008. Epub 2008 May 6.
- Background: PubMed 17728400Roy S, Patel D, Khanna S, Gordillo GM, Biswas S, Friedman A, Sen CK. Transcriptome-wide analysis of blood vessels laser captured from human skin and chronic wound-edge tissue. Proc Natl Acad Sci U S A. 2007 Sep 4;104(36):14472-7. doi: 10.1073/pnas.0706793104. Epub 2007 Aug 29.
- Background: PubMed 17474876Schafer M, Werner S. Transcriptional control of wound repair. Annu Rev Cell Dev Biol. 2007;23:69-92. doi: 10.1146/annurev.cellbio.23.090506.123609.
- Background: PubMed 19903300Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.
- Background: PubMed 18258815Shilo S, Roy S, Khanna S, Sen CK. Evidence for the involvement of miRNA in redox regulated angiogenic response of human microvascular endothelial cells. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):471-7. doi: 10.1161/ATVBAHA.107.160655. Epub 2008 Feb 7.
- Background: PubMed 17465889Shilo S, Roy S, Khanna S, Sen CK. MicroRNA in cutaneous wound healing: a new paradigm. DNA Cell Biol. 2007 Apr;26(4):227-37. doi: 10.1089/dna.2006.0568.
- Background: PubMed 17199834Hopf HW, Ueno C, Aslam R, Burnand K, Fife C, Grant L, Holloway A, Iafrati MD, Mani R, Misare B, Rosen N, Shapshak D, Benjamin Slade J Jr, West J, Barbul A. Guidelines for the treatment of arterial insufficiency ulcers. Wound Repair Regen. 2006 Nov-Dec;14(6):693-710. doi: 10.1111/j.1524-475X.2006.00177.x. No abstract available.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Foot Ulcer, run by Indiana University at 4 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 6 inclusion and 9 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: finished, 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 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wound-edge endothelial miR-200b (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02581098, which also lists 14 linked publications.
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.