Diabetic Foot Ulcers Microbiome and Pathogen Identification

Recruiting

• Conditions: Wound; Foot Ulcer; Diabetes Mellitus
• Interventions: Procedure: Wound debridement

• Registration Number: NCT05556954
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Study Start: 2022-10-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-infected DFU cohort	Wound debridement	75 non-infected participants with DFU will be enrolled.
Infected DFU cohort	Wound debridement	25 participants that have an infected DFU will be enrolled.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The percent of clinically resolved infected DFU for infected diabetic foot ulcer participants	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).
Total days of antibiotic therapy for the DFU infected diabetic foot ulcer participants	Baseline to 12 weeks
The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4	Baseline to 4 weeks
Post-study percentage change of wound surface area (cm2) for both cohorts	Baseline to 12 weeks
Proportion of participants that reach a 50% reduction in surface area of the DFU for both cohorts	Baseline to 4 weeks
Number of days to infection resolution for the DFU infected diabetic foot ulcer participants	Baseline to 12 weeks

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States