Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence (DFU Biofilm)

  • days left to enroll
Updated on 25 March 2022
alzheimer's disease


A clinical trial to compare Diabetic foot ulcer recovery rates in patients with Alzheimer's Disease and related disorders versus patients without Alzheimer's.


There are 4 visits in the study. You will be paid $200 for completion of Study Visit 1, and $50 for completion of Study Visit 2. Study Visits 3 and 4 will be paid $50 for each visit completed. The study team will collect information about you from your medical records. This information, some of which may identify you, may be used for research-related purposes. This may include: making sure you meet the criteria to be in this study, gathering information about your medical history to include in the research data, reviewing results of your medical tests for safety purposes, checking on your health in the future to help answer our research question, or to inspect and/or copy your research records for quality assurance and data analysis. During each visit, subjects' medical data will be reviewed, including blood reports and scan reports. Their wounds will be photographed (without including any identifying features in photograph) and lab samples will be collected. An informed consent form will be offered for signature to the subjects' LARs (Legally Authorized Representatives). Subjects (or LARs) will be asked to answer health-related questionnaires. The 4 visits will be scattered over a maximum period of 8 months. All visit stipends will be given on the days of the visits, in cash. Every effort will be made to keep your personal information confidential, but we cannot guarantee absolute confidentiality. No information which could identify you will be shared in publications about this study. Your personal information may be shared outside the research study if required by law and/or to individuals or organizations that oversee the conduct of research studies, and these individuals or organizations may not be held to the same legal privacy standards as are doctors and hospitals. This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use any information, documents, or specimens that could identify you in any legal action or lawsuit unless you say it is okay.

Condition Alzheimer’s Disease, Dementia, Diabetes, Chronic Ulcers
Clinical Study IdentifierTX291194
Last Modified on25 March 2022


Yes No Not Sure

Inclusion Criteria

Male or Female, Age ≥ 18 with a clinical diagnosis of Alzheimer’s Disease or Related Dementias (AD/ADRD)
An available Legally Authorized Representative (LAR), as needed, to provide consent
Willing to comply with protocol instructions, including all study visits and study activities
Clinically diagnosed with diabetes as defined by the American Diabetes Association
Chronic would defined as any ulcer that has been open for ≥ 30 days
Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee)
TcOM >30 mmHg
Ankle-brachial index ≥0.7-1.20
Toe pressure > 30 mmHg
TBI > 0.6 mmHg

Exclusion Criteria

Wounds closed or to be surgically closed by flap or graft coverage
Subjects with marked immunodeficiency (HIV/AIDS, or on immunosuppressive medications
TcOM < 30mmHg
Diabetics with a hemoglobin A1c > 10 within 3 months prior to enrollment
Subject with autoimmune connective tissue disease
Ulcer size and location that does not allow the TEWL measurement per SOP
Unable to comply with study procedures and/or complete study visits
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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