Diabetic Foot Ulcers Microbiome and Pathogen Identification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-13

Study Completion Date

2025-06-04

Brief Summary

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This research is being done because people with diabetes have reduced healing capacity and prone to develop infections of foot wounds. This can be problematic because wounds that become infected may result in amputation and more severe complications. New evidence suggests that a better understanding of the microbiome of wounds (e.g., bacterial presence) may provide information about wound healing and provide an earlier opportunity to identify an individual who may be prone to develop diabetic foot infection in their wound.

Therefore, the purpose of this study is to evaluate the role of the microbiome of the diabetic foot ulcer in development of infection and wound healing. Once the role of the microbiome is confirmed, progress towards the prevention and treatment of diabetic foot ulcers and complications may be possible.

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Detailed Description

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Conditions

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Foot Ulcer Diabetes Mellitus Wound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infected DFU cohort

25 participants that have an infected DFU will be enrolled.

Wound debridement

Intervention Type PROCEDURE

Participant that are having usual care visits for management of diabetic foot ulcers will be enrolled into this study. The procedure is done as part of standard of care. Tissue from the samples will be analyzed for this study.

Aliquoting and Deoxyribonucleic acid (DNA) extraction will be done on the specimens. Bacterial DNA from biospecimens will be isolated, quantified, amplified, and sequenced.

Non-infected DFU cohort

75 non-infected participants with DFU will be enrolled.

Wound debridement

Intervention Type PROCEDURE

Participant that are having usual care visits for management of diabetic foot ulcers will be enrolled into this study. The procedure is done as part of standard of care. Tissue from the samples will be analyzed for this study.

Aliquoting and Deoxyribonucleic acid (DNA) extraction will be done on the specimens. Bacterial DNA from biospecimens will be isolated, quantified, amplified, and sequenced.

Interventions

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Wound debridement

Participant that are having usual care visits for management of diabetic foot ulcers will be enrolled into this study. The procedure is done as part of standard of care. Tissue from the samples will be analyzed for this study.

Aliquoting and Deoxyribonucleic acid (DNA) extraction will be done on the specimens. Bacterial DNA from biospecimens will be isolated, quantified, amplified, and sequenced.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* DFU patients with diabetes mellitus
* Have a hemoglobin A1c\[HbA1c\] of 12% or less as measured within the last 6 months
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

* Pregnant or lactating
* Uncontrolled blood glucose as demonstrated by by a HbA1c of greater than 12%
* Bilateral wound or ulcer
* Current infection of Coronavirus (COVID-19)
* Unable to provide informed consent or are unwilling to participate.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No