Skip to main content
OpenTrials
Completed

NCT Number: NCT05556954

Diabetic Foot Ulcers Microbiome and Pathogen Identification

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Foot Ulcer Diabetes Mellitus Endocrine System Diseases Foot Diseases Glucose Metabolism Disorders Infections Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wound Wound Infection Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wound Debridement

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.

Primary outcomes

  1. The percent change in foot ulcer surface area (cm2) after 12 weeks of observation for either infected or non-infected diabetic foot ulcers

    Time frame: Baseline to 12 weeks

Secondary outcomes

  1. The percent of clinically resolved infected DFU for infected diabetic foot ulcer participants

    Time frame: Baseline to 12 weeks

    Defined as improvement of greater or equal to 2 clinical signs (Local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge) with no requirement for additional antibiotic(s).

  2. Total days of antibiotic therapy for the DFU infected diabetic foot ulcer participants

    Time frame: Baseline to 12 weeks

  3. Number of days to infection resolution for the DFU infected diabetic foot ulcer participants

    Time frame: Baseline to 12 weeks

  4. The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4

    Time frame: Baseline to 4 weeks

  5. Post-study percentage change of wound surface area (cm2) for both cohorts

    Time frame: Baseline to 12 weeks

  6. Proportion of participants that reach a 50% reduction in surface area of the DFU for both cohorts

    Time frame: Baseline to 4 weeks

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

The Role of The Microbiome in Diabetic Foot Ulcers (DFU)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2022
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.