NCT05556954

Diabetic Foot Ulcers Microbiome and Pathogen Identification

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Foot Ulcer
• Diabetes Mellitus
• Wound

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2022-10-13
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2022-09-27
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States