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Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing

Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03271580
Enrollment
31
Registered
2017-09-05
Start date
2020-02-01
Completion date
2021-09-13
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections, Diabetes Mellitus, Infected Ulcer of Skin, Wound

Keywords

Wound healing, Diabetes, Inflammatory cells, Macrophage

Brief 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.

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)

Interventions

DIAGNOSTIC_TESTFinger prick test for HbA1c measurement

HbA1c measurement with finger prick method

PROCEDUREPunch Biopsy

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).

OTHERVac Sponge Collection

NPWT sponge which is discarded as biological waste, will be collected for wound macrophage isolation

Blood pressure test

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age 18 and above years old 2. Willing and able to provide informed consent 3. Willing and able to comply with protocol instructions, including biopsies and study visits 4. Diabetics with an open wound 5. Receiving Negative Wound Pressure Therapy (NPWT)

Exclusion criteria

1. Inadequate arterial supply, as evidenced by any of the following (for wounds below the knee): 1. TcOM \< 30mmHg 2. ABI \< 0.7 3. TBI \< 0.6 2. Women who are pregnant

Design outcomes

Primary

MeasureTime frameDescription
Biofilm infection14 WeeksBiofilm Infection using SEM and RT PCR analysis
macrophage phenotyping14 WeeksWound macrophage phenotypes using flowcytometry, RTPCR and RNA Seq

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026