Actively Recruiting
Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers: Open Wound Master Study
Led by University of Michigan · Updated on 2025-09-15
5000
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying diabetic foot ulcers (DFUs) to identify biomarkers that can predict which ulcers are more likely to heal. This observational platform study aims to improve personalized care decisions and enhance future clinical trials for wound healing. It includes patients with active DFUs seen in outpatient diabetic foot and wound care clinics across various healthcare settings. The study collects a wide range of data, including biospecimens and patient-reported outcomes, to better understand wound healing patterns and recurrence rates. The study does not involve any experimental treatments; instead, participants receive usual clinical care at their respective clinics. Biospecimens collected include blood, wound fluid, wound dressings, and tissue from debridement if performed. Urine samples are also encouraged when possible. The study is flexible and can include additional biomarker-specific substudies. Participants may be enrolled in multiple substudies without needing new consent. Participants will be followed for up to 78 weeks, with visits every two weeks for the first month and monthly thereafter until the wound heals or up to week 52 if it does not. After healing, confirmation visits and assessments for ulcer recurrence occur via phone or video at weeks 52 and 78. Data collected includes wound healing status, infections, amputations, biospecimen quality, adherence to care, and physical and mental health scores. This comprehensive follow-up helps improve standards of care and supports personalized treatment approaches for DFUs.
CONDITIONS
Brief Title
DFC 004 Biomarkers for Active Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed and dated informed consent.
- Be 18 years old or older.
- Have a clinical diagnosis of diabetes or meet ADA criteria for diabetes.
- Have an open foot ulcer at or below the ankle, including open post-surgical wounds.
- Agree to attend study visits and provide required biospecimens and clinical data.
You will not qualify if you...
- Participation in an interventional diabetic foot ulcer clinical trial within 1 month before the first visit.
- Currently receiving radiation therapy or chemotherapy targeting the foot area.
- Presence of gangrene in any part of the foot with the index ulcer.
- Planned or under evaluation for revascularization of the affected limb within 4 weeks of study start.
- Severe limb ischemia graded as SVS WIfl Ischemia grade 3.
- Any medical or psychiatric condition that may prevent safe completion of the study, as judged by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks or until wound healing
Participants who undergo routine care for diabetic foot ulcers are observed. Blood, wound fluid, wound dressings, and tissue samples are collected to support research. Urine samples may be collected if participants agree. Clinical data and care details at each clinic visit are recorded.
Visits every other week for 1 month, then monthly until wound healing or Week 52
Duration - Up to 26 weeks after healing or Week 78
After wound healing is confirmed, participants have a confirmation visit and are assessed for ulcer recurrence through phone or video visits. Participants without wound healing by Week 52 have additional remote assessments.
1 confirmation visit 2 weeks after healing and phone/video visits at Weeks 52 and 78
Trial Site Locations
Total: 8 locations
1
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724
Actively Recruiting
2
University of Southern California
Los Angeles, California, United States, 90033
Active, Not Recruiting
3
University of California - San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
Actively Recruiting
5
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
8
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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