Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing

September 29, 2023 updated by: Dr. Sashwati Roy, Indiana University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bryce Hockman, CCRP
  • Phone Number: 317 278 2715
  • Email: bbhockma@iu.edu

Study Contact Backup

  • Name: Kaitlyn Depinet, FNP-C
  • Phone Number: 317 278 2747
  • Email: kdepinet@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: Finger prick test for HbA1c measurement
HbA1c measurement with finger prick method
Procedure: Punch 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).
Other: Vac Sponge Collection
NPWT sponge which is discarded as biological waste, will be collected for wound macrophage isolation
Other: Ankle Brachial Index
Blood pressure test
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
Diagnostic test: Finger prick test for HbA1c measurement
HbA1c measurement with finger prick method
Procedure: Punch 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).
Other: Vac Sponge Collection
NPWT sponge which is discarded as biological waste, will be collected for wound macrophage isolation
Other: Ankle Brachial Index
Blood pressure test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biofilm infection
Time Frame: 14 Weeks
Biofilm Infection using SEM and RT PCR analysis
14 Weeks
macrophage phenotyping
Time Frame: 14 Weeks
Wound macrophage phenotypes using flowcytometry, RTPCR and RNA Seq
14 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Sashwati Roy, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

September 13, 2021

Study Completion (Actual)

September 13, 2021

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1808802536

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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