Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing

Indiana University

Status: Terminated

Conditions: Wound; Diabetes Mellitus; Infected Ulcer of Skin; Bacterial Infections

Treatments: Diagnostic Test: Finger prick test for HbA1c measurement; Procedure: Punch Biopsy; Other: Vac Sponge Collection; Other: Ankle Brachial Index

Study type: Observational

Funder types: Other

Identifiers

NCT03271580

1808802536

Details and patient eligibility

About

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.

Full 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)

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

31 participants in 2 patient groups

Diabetic patients infected ulcers

Description:

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

Treatment:

Procedure: Punch Biopsy

Diagnostic Test: Finger prick test for HbA1c measurement

Other: Ankle Brachial Index

Other: Vac Sponge Collection

Diabetic patients non infected Ulcers

Description:

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

Treatment:

Procedure: Punch Biopsy

Diagnostic Test: Finger prick test for HbA1c measurement

Other: Ankle Brachial Index

Other: Vac Sponge Collection