WoundNCT03271580
Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing
An observational study of Wound and Bacterial Infections, run by Indiana University at 5 sites in United States.
Trial summary
The purpose of this study is to learn more about biofilm and to see how it affects diabetic wounds. A biofilm can occur if a chronic infection causes bacteria to grow in a slime enclosed group. This grouping of bacteria is called a biofilm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound, Bacterial Infections, Diabetes Mellitus
- What is being tested?
- Finger prick test for HbA1c measurement, Punch Biopsy and Vac Sponge Collection
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Feb 2020to 13 Sep 2021
- 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: Twenty-eight diabetic subjects with chronic foot ulcer(s) that are receiving Negative Wound Pressure Therapy (NPWT) will be enrolled. Eighteen subjects will be infected and 10 subjects will be non-infected serving as the control for the study. The inclusion and exclusion criteria were carefully selected to enroll diabetic patients who have wound tissue oxygenation adequate to support wound healing.
Who may be able to join
- Age 18 and above years old
- Willing and able to provide informed consent
- Willing and able to comply with protocol instructions, including biopsies and study visits
- Diabetics with an open wound
- Receiving Negative Wound Pressure Therapy (NPWT)
Who cannot join
- Inadequate arterial supply, as evidenced by any of the following (for wounds below the knee):
- TcOM < 30mmHg
- ABI < 0.7
- TBI < 0.6
- Women who are pregnant
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Davis Heart and Lung Institute
Columbus, Ohio, 42310
The Ohio State University Hospital East
Columbus, Ohio, 43203
Comprehensive Wound Care Centers, The Ohio State University Hospital
Columbus, Ohio, 43210
Martha Morehouse Medical Plaza
Columbus, Ohio, 43221
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to learn more about biofilm and to see how it affects diabetic wounds. A biofilm can occur if a chronic infection causes bacteria to grow in a slime enclosed group. This grouping of bacteria is called a biofilm.
Read the detailed description
There is one study visit with a 14-week follow-up that will take place during the participants standard of care visit at the Indiana University Health Comprehensive Wound Center (CWC). The following procedures will take place once your appointment has been completed:
- Informed consent will be signed (if not previously signed)
- A hemoglobin A1c drawn will be taken by research personnel, if one has not been done within the last 90 days to check your average blood sugar level.
- An Ankle Brachial Index (ABI) will be obtained if the participant has a leg wound. This is to ensure that participants have adequate blood flow to your wound. This is a non-invasive test which measures blood pressure in both of the participants arms and ankles.
- Demographics (such as your name and address and phone number, age), medical history, current medications, current standard of care labs, and wound data (measurements, cause of the wound, wound culture, assessments, treatments, and duration) will be recorded. The participant's medical record number will also be recorded.
- A photo of the wound site will be taken.
- Wound Vac Collection - The wound vac sponge will be collected (waste by product of the therapy) by the research staff.
- An optional two 3 mm punch tissue biopsies will be obtained from the participant's provider. To perform the biopsy, the area surrounding the wound will first be numbed using a local anesthetic agent that will be injected at the wound site. Then, a pencil-like instrument will be used to remove a small, thin cylinder of tissue. Each biopsy is about the size of this dot. After the tissue is removed, a sterile gauze will be placed on the area to stop any minor bleeding that may occur. The biopsies will be looked at in the laboratory to look at the microorganisms. You will not receive the results of the completed laboratory analysis. (Note: If two biopsies cannot be obtained per your physician's discretion, only one biopsy, debridement tissue (dead tissue that is removed from your wound) or no tissue will be obtained, and/or culture swabs (your wound will be swabbed with something like a Q-tip to collect cells to test for bacteria or other organisms in the wound) will be collected to test for infection.)
During the 14-week follow-up visit, research staff will review the participant's medical chart to determine the final status of the wound. If the participant does not return to the CWC at 14 weeks, the last CWC visit will be documented as the wound check follow-up. This does not require the participant to return for an extra study visit. This information will only be collected from their medical chart if available:
- Final status of the wound (healing, not healing, healed)
- Wound data (measurements), treatments, and any standard of care labs will be obtained
- A photo of your wound from the medical chart will be obtained (if available)
- Conditions
- Wound, Bacterial Infections, Diabetes Mellitus, Infected Ulcer of Skin
- Being tested
- Finger prick test for HbA1c measurement, Punch Biopsy, Vac Sponge Collection, Ankle Brachial Index
- Keywords
- Wound healing, Diabetes, Inflammatory cells, Macrophage
- Medical subject headings
- Wounds and Injuries, Bacterial Infections, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger prick test for HbA1c measurementDiagnostic test
HbA1c measurement with finger prick method
Punch BiopsyProcedure or surgery
Wound site will be anaesthetized, by punch biopsy tissue will be collected, wound site will be monitored for bleeding(if bleeding Cautery will be used to stop bleeding).
Vac Sponge CollectionOther
NPWT sponge which is discarded as biological waste, will be collected for wound macrophage isolation
Ankle Brachial IndexOther
Blood pressure test
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients infected ulcers | Diabetic patients with HbA1c<9 with who have wound 4weeks or longer with infection with following interventions:
1. Finger prick test for HbA1c measurement
2. Punch biopsy
3. VAC sponge collection
4. Ankle brachial index Receives: Diagnostic Test: Finger prick test for HbA1c measurement; Procedure: Punch Biopsy; Other: Vac Sponge Collection; Other: Ankle Brachial Index | |
| Diabetic patients non infected Ulcers | Diabetic patients with HbA1c<9 who have wound 4 weeks or longer without infection with following interventions:
1. Finger prick test for HbA1c measurement
2. Punch biopsy
3. VAC sponge collection
4. Ankle brachial index Receives: Diagnostic Test: Finger prick test for HbA1c measurement; Procedure: Punch Biopsy; Other: Vac Sponge Collection; Other: Ankle Brachial Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biofilm infection
Biofilm Infection using SEM and RT PCR analysis
Measured: 14 Weeks
macrophage phenotyping
Wound macrophage phenotypes using flowcytometry, RTPCR and RNA Seq
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 posted5 Sep 2017
- Study start1 Feb 2020
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Why it stopped: Insufficient Staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for WoundStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sashwati Roy, Indiana University
- Investigators
- Sashwati Roy, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271580
- Sponsor's protocol ID
- 1808802536
- Status last verified
- Apr 2024
- First submitted
- 12 Jun 2017
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breen JD, Karchmer AW. Staphylococcus aureus infections in diabetic patients. Infect Dis Clin North Am. 1995 Mar;9(1):11-24.
PubMed 7769212Davis SC, Martinez L, Kirsner R. The diabetic foot: the importance of biofilms and wound bed preparation. Curr Diab Rep. 2006 Dec;6(6):439-45. doi: 10.1007/s11892-006-0076-x.
PubMed 17118226James GA, Swogger E, Wolcott R, Pulcini Ed, Secor P, Sestrich J, Costerton JW, Stewart PS. Biofilms in chronic wounds. Wound Repair Regen. 2008 Jan-Feb;16(1):37-44. doi: 10.1111/j.1524-475X.2007.00321.x. Epub 2007 Dec 13.
PubMed 18086294Hanke ML, Angle A, Kielian T. MyD88-dependent signaling influences fibrosis and alternative macrophage activation during Staphylococcus aureus biofilm infection. PLoS One. 2012;7(8):e42476. doi: 10.1371/journal.pone.0042476. Epub 2012 Aug 3.
PubMed 22879997Hanke ML, Heim CE, Angle A, Sanderson SD, Kielian T. Targeting macrophage activation for the prevention and treatment of Staphylococcus aureus biofilm infections. J Immunol. 2013 Mar 1;190(5):2159-68. doi: 10.4049/jimmunol.1202348. Epub 2013 Jan 30.
PubMed 23365077Neut D, Tijdens-Creusen EJ, Bulstra SK, van der Mei HC, Busscher HJ. Biofilms in chronic diabetic foot ulcers--a study of 2 cases. Acta Orthop. 2011 Jun;82(3):383-5. doi: 10.3109/17453674.2011.581265. Epub 2011 May 11. No abstract available.
PubMed 21561305Zhao G, Usui ML, Lippman SI, James GA, Stewart PS, Fleckman P, Olerud JE. Biofilms and Inflammation in Chronic Wounds. Adv Wound Care (New Rochelle). 2013 Sep;2(7):389-399. doi: 10.1089/wound.2012.0381.
PubMed 24527355
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
- Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing
- ClinicalTrials.gov ID
- NCT03271580
- Acronym / sponsor ID
- 1808802536
- Conditions
- Wound, Bacterial Infections, Diabetes Mellitus, Infected Ulcer of Skin
- Keywords
- Wound healing, Diabetes, Inflammatory cells, Macrophage
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient Staff
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 5 Sep 2017 (actual)
- 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.
The purpose of this study is to learn more about biofilm and to see how it affects diabetic wounds. A biofilm can occur if a chronic infection causes bacteria to grow in a slime enclosed group. This grouping of bacteria is called a biofilm.
Detailed description
There is one study visit with a 14-week follow-up that will take place during the participants standard of care visit at the Indiana University Health Comprehensive Wound Center (CWC). The following procedures will take place once your appointment has been completed:
- Informed consent will be signed (if not previously signed)
- A hemoglobin A1c drawn will be taken by research personnel, if one has not been done within the last 90 days to check your average blood sugar level.
- An Ankle Brachial Index (ABI) will be obtained if the participant has a leg wound. This is to ensure that participants have adequate blood flow to your wound. This is a non-invasive test which measures blood pressure in both of the participants arms and ankles.
- Demographics (such as your name and address and phone number, age), medical history, current medications, current standard of care labs, and wound data (measurements, cause of the wound, wound culture, assessments, treatments, and duration) will be recorded. The participant's medical record number will also be recorded.
- A photo of the wound site will be taken.
- Wound Vac Collection - The wound vac sponge will be collected (waste by product of the therapy) by the research staff.
- An optional two 3 mm punch tissue biopsies will be obtained from the participant's provider. To perform the biopsy, the area surrounding the wound will first be numbed using a local anesthetic agent that will be injected at the wound site. Then, a pencil-like instrument will be used to remove a small, thin cylinder of tissue. Each biopsy is about the size of this dot. After the tissue is removed, a sterile gauze will be placed on the area to stop any minor bleeding that may occur. The biopsies will be looked at in the laboratory to look at the microorganisms. You will not receive the results of the completed laboratory analysis. (Note: If two biopsies cannot be obtained per your physician's discretion, only one biopsy, debridement tissue (dead tissue that is removed from your wound) or no tissue will be obtained, and/or culture swabs (your wound will be swabbed with something like a Q-tip to collect cells to test for bacteria or other organisms in the wound) will be collected to test for infection.)
During the 14-week follow-up visit, research staff will review the participant's medical chart to determine the final status of the wound. If the participant does not return to the CWC at 14 weeks, the last CWC visit will be documented as the wound check follow-up. This does not require the participant to return for an extra study visit. This information will only be collected from their medical chart if available:
- Final status of the wound (healing, not healing, healed)
- Wound data (measurements), treatments, and any standard of care labs will be obtained
- A photo of your wound from the medical chart will be obtained (if available)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients infected ulcers | – | Diagnostic Test: Finger prick test for HbA1c measurement, Procedure: Punch Biopsy, Other: Vac Sponge Collection, Other: Ankle Brachial IndexDiabetic patients with HbA1c<9 with who have wound 4weeks or longer with infection with following interventions: 1. Finger prick test for HbA1c measurement 2. Punch biopsy 3. VAC sponge collection 4. Ankle brachial index |
| Diabetic patients non infected Ulcers | – | Diagnostic Test: Finger prick test for HbA1c measurement, Procedure: Punch Biopsy, Other: Vac Sponge Collection, Other: Ankle Brachial IndexDiabetic patients with HbA1c<9 who have wound 4 weeks or longer without infection with following interventions: 1. Finger prick test for HbA1c measurement 2. Punch biopsy 3. VAC sponge collection 4. Ankle brachial index |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty-eight diabetic subjects with chronic foot ulcer(s) that are receiving Negative Wound Pressure Therapy (NPWT) will be enrolled. Eighteen subjects will be infected and 10 subjects will be non-infected serving as the control for the study. The inclusion and exclusion criteria were carefully selected to enroll diabetic patients who have wound tissue oxygenation adequate to support wound healing.
Key inclusion criteria (5 listed)
- Age 18 and above years old
- Willing and able to provide informed consent
- Willing and able to comply with protocol instructions, including biopsies and study visits
- Diabetics with an open wound
- Receiving Negative Wound Pressure Therapy (NPWT)
Key exclusion criteria (5 listed)
- Inadequate arterial supply, as evidenced by any of the following (for wounds below the knee):
- Women who are pregnant
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 |
|---|---|---|
| Finger prick test for HbA1c measurementHbA1c measurement with finger prick method | Diagnostic test | Diabetic patients infected ulcers, Diabetic patients non infected Ulcers |
| Punch BiopsyWound site will be anaesthetized, by punch biopsy tissue will be collected, wound site will be monitored for bleeding(if bleeding Cautery will be used to stop bleeding). | Procedure or surgery | Diabetic patients infected ulcers, Diabetic patients non infected Ulcers |
| Vac Sponge CollectionNPWT sponge which is discarded as biological waste, will be collected for wound macrophage isolation | Other | Diabetic patients infected ulcers, Diabetic patients non infected Ulcers |
| Ankle Brachial IndexBlood pressure test | Other | Diabetic patients infected ulcers, Diabetic patients non infected Ulcers |
Primary outcome
Biofilm infection
Time frame: 14 Weeks
Biofilm Infection using SEM and RT PCR analysis
macrophage phenotyping
Time frame: 14 Weeks
Wound macrophage phenotypes using flowcytometry, RTPCR and RNA Seq
Results and safety
The study was stopped early (reason given: Insufficient Staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 7769212Breen JD, Karchmer AW. Staphylococcus aureus infections in diabetic patients. Infect Dis Clin North Am. 1995 Mar;9(1):11-24.
- Background: PubMed 17118226Davis SC, Martinez L, Kirsner R. The diabetic foot: the importance of biofilms and wound bed preparation. Curr Diab Rep. 2006 Dec;6(6):439-45. doi: 10.1007/s11892-006-0076-x.
- Background: PubMed 18086294James GA, Swogger E, Wolcott R, Pulcini Ed, Secor P, Sestrich J, Costerton JW, Stewart PS. Biofilms in chronic wounds. Wound Repair Regen. 2008 Jan-Feb;16(1):37-44. doi: 10.1111/j.1524-475X.2007.00321.x. Epub 2007 Dec 13.
- Background: PubMed 22879997Hanke ML, Angle A, Kielian T. MyD88-dependent signaling influences fibrosis and alternative macrophage activation during Staphylococcus aureus biofilm infection. PLoS One. 2012;7(8):e42476. doi: 10.1371/journal.pone.0042476. Epub 2012 Aug 3.
- Background: PubMed 23365077Hanke ML, Heim CE, Angle A, Sanderson SD, Kielian T. Targeting macrophage activation for the prevention and treatment of Staphylococcus aureus biofilm infections. J Immunol. 2013 Mar 1;190(5):2159-68. doi: 10.4049/jimmunol.1202348. Epub 2013 Jan 30.
- Background: PubMed 21561305Neut D, Tijdens-Creusen EJ, Bulstra SK, van der Mei HC, Busscher HJ. Biofilms in chronic diabetic foot ulcers--a study of 2 cases. Acta Orthop. 2011 Jun;82(3):383-5. doi: 10.3109/17453674.2011.581265. Epub 2011 May 11. No abstract available.
- Background: PubMed 24527355Zhao G, Usui ML, Lippman SI, James GA, Stewart PS, Fleckman P, Olerud JE. Biofilms and Inflammation in Chronic Wounds. Adv Wound Care (New Rochelle). 2013 Sep;2(7):389-399. doi: 10.1089/wound.2012.0381.
- Individual participant dataSharing planned: No
Related trials for Wound
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
Sashwati Roy, PhD principal investigator
Indiana University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound and Bacterial Infections, run by Indiana University at 5 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 5 inclusion and 5 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 5 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: Insufficient Staff). 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?
Biofilm infection (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 NCT03271580, which also lists 7 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.