- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03479242
Diabetic Foot Ulcer Recurrence: Pilot Study (DFUCO)
To Study Diabetic Foot Ulcer Recurrence With Trans Epidermal Water Loss Measured With Derma Lab
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diabetes impairs immune defenses such that the ability to fight wound infection is weakened. Thus, infection is a major problem in diabetic foot ulcers (DFUs) . Biofilms are estimated to account for 60% of chronic wound infections6. In biofilm bacteria are encased within extra polymeric substance (EPS) and become recalcitrant to antimicrobials and host defenses.In the biofilm form, bacteria may not form colony. Thus, standard clinical techniques like CFU to detect infection may not detect biofilm infection. Thus, biofilm infection may be viewed as a silent threat in wound care. Using a preclinical swine model of mixed species wound biofilm infection, we struck an unusual observation. Although biofilm infection may or may not influence the rate of wound closure as measured by standard planimetry, it inevitably compromises the functional property of the repaired skin. The wound may close as evaluated visually, but that closed wound lacks barrier function. Such pathology is caused by the perturbation of epithelial junctional proteins in response to biofilm infection. While detecting the biofilm directly is readily not possible at present in the wound clinics, compromised barrier function of the repaired skin can be detected at the point of care of the measurement of trans-epidermal water loss (TEWL). This pilot study, we propose, many DFUs that are currently served with a CLOSED clinical decision may have had a history of biofilm infection and therefore remained functionally open.
Considering that such incomplete wound closure may have a higher risk of wound recidivism, it becomes critically important that wound closure decisions be guided by functional tests in addition to factors currently considered. Importantly, substantial change in health impact may be achieved by a simple functional test as implemented by the measurement of trans epidermal water loss (TEWL). TEWL can be performed by clinical staff at the point of care within 15 minutes with minimum training using inexpensive hand- held pen like commercial gadgets approved for clinical use.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- IU Health Methodist Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18
- Willing to comply with protocol instructions, including all study visits and study activities.
- Diabetic foot ulcers
Adequate arterial blood flow as evidenced by at least one of the following:
- TCOM > 30 mmHg
- Ankle-brachial index ≥0.7
- Toe pressure > 30 mmHg
Exclusion Criteria:
- Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent)
- Wounds closed or to be closed by flap or graft coverage
- Prisoners
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional skin closure in DFU in relation to biofilm infection
Time Frame: 7 months
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TEWL will be measured to check for functional wound closure and see if DFU recidivism is high in subjects with a history of biofilm infection
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7 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chandan K Sen, PhD, Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1808823394
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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