Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing

Terminated

• Conditions: Bacterial Infections; Infected Ulcer of Skin; Diabetes Mellitus; Wound
• Interventions: Diagnostic Test: Finger prick test for HbA1c measurement; Procedure: Punch Biopsy; Other: Vac Sponge Collection; Other: Ankle Brachial Index

• Registration Number: NCT03271580
• Lead Sponsor: Indiana University

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-05
• Study Start: 2020-02-01
• Primary Completion: 2021-09-13
• Study Completion: 2021-09-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patients infected ulcers	Punch Biopsy	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
Diabetic patients non infected Ulcers	Finger prick test for HbA1c measurement	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
Diabetic patients non infected Ulcers	Vac Sponge Collection	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
Diabetic patients infected ulcers	Finger prick test for HbA1c measurement	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
Diabetic patients infected ulcers	Ankle Brachial Index	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
Diabetic patients non infected Ulcers	Punch Biopsy	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
Diabetic patients infected ulcers	Vac Sponge Collection	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
Diabetic patients non infected Ulcers	Ankle Brachial Index	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

Primary Outcome Measures

Name	Time	Method
macrophage phenotyping	14 Weeks	Wound macrophage phenotypes using flowcytometry, RTPCR and RNA Seq
Biofilm infection	14 Weeks	Biofilm Infection using SEM and RT PCR analysis

Trial Locations

Locations (5)

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Davis Heart and Lung Institute; 🇺🇸 Columbus, Ohio, United States

The Ohio State University Hospital East; 🇺🇸 Columbus, Ohio, United States

Comprehensive Wound Care Centers, The Ohio State University Hospital; 🇺🇸 Columbus, Ohio, United States

Martha Morehouse Medical Plaza; 🇺🇸 Columbus, Ohio, United States