Diabetic Foot Ulcers Microbiome and Pathogen Identification

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556954
• Other study ID #: HUM00214995
• Secondary ID: K23DK131261
• Status: Recruiting
• Start date: October 13, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: Kourtney Noll
• Phone: 734-763-4156
• Email: kneibaue[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Foot Ulcer
• Ulcer
• Wound

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent change in foot ulcer surface area (cm2) after 12 weeks of observation for either infected or non-infected diabetic foot ulcers		Baseline to 12 weeks
Secondary	The percent of clinically resolved infected DFU for infected diabetic foot ulcer participants	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).	Baseline to 12 weeks
Secondary	Total days of antibiotic therapy for the DFU infected diabetic foot ulcer participants		Baseline to 12 weeks
Secondary	Number of days to infection resolution for the DFU infected diabetic foot ulcer participants		Baseline to 12 weeks
Secondary	The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4		Baseline to 4 weeks
Secondary	Post-study percentage change of wound surface area (cm2) for both cohorts		Baseline to 12 weeks
Secondary	Proportion of participants that reach a 50% reduction in surface area of the DFU for both cohorts		Baseline to 4 weeks