DFC 004 Biomarkers for Active Diabetic Foot Ulcers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form.
Age 18 years or older.
Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. [ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1]
Open foot ulcer, defined as an open wound from malleolus down. This includes post-surgical wounds within this area left open to heal by secondary intention. In case of multiple ulcers, the largest ulcer will be considered the study index DFU.
Disqualifiers
Participation in an interventional clinical trial for DFU within 1 month of Visit 1.
Currently receiving radiation to target area or chemotherapy.
Gangrene in any portion of the foot with the index ulcer.
Planned revascularization or under evaluation for revascularization of the index limb for advanced ischemia within next 4 weeks of Week 0.
Trial population
Adults with diabetes with at least one open diabetic foot ulcer.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: Diabetic Foot Ulcer
Trial outcomes
Primary outcomes
1
Wound Healing
Proportion of participants with complete wound healing by week 52, defined as complete wound closure where there is skin re-epithelialization without drainage or dressing requirements at two consecutive study visits 2 weeks apart.
Time frame
52 Weeks2
DFU Infections
Proportion of participants who develop infections of the index DFU among those with no infections at baseline.
Time frame
52 Weeks3
Amputations
Proportion of participants who have an amputation of the limb associated with the index DFU.
Time frame
52 Weeks4
Prediction Performance
Measures of prediction performance (e.g., predictive power, AUC, ROC, Akaike information criterion) of biomarker(s) for each of the clinical outcomes: Wound Healing, DFU Infections, and Amputations described above. Prediction performance is measured by multiple statistical measures to assess ability of the biomarker to predict event risk for each of the three clinical outcomes.
Time frame
52 WeeksSecondary outcomes
1
Time to Healing
Time to healing, defined as the time (in weeks) from baseline to complete healing.
Time frame
Up to 52 Weeks2
Change from baseline to later of Week 52 or Confirmation Visit in SF-12 Physical Domain Score
Change from baseline to later of Week 52 or Confirmation Visit in: SF-12 physical domain score. SF-12 for physical * Score range from 0-100 * Higher scores indicate better physical health.
Time frame
52 Weeks3
Change from baseline to later of Week 52 or Confirmation Visit in SF-12 Mental Domain Score
Change from baseline to later of Week 52 or Confirmation Visit in: SF-12 mental domain score. * Score range from 0-100 * Higher scores indicate better mental health.
Time frame
52 Weeks4
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF subscale leisure score.
Change from baseline to later of Week 52 or Confirmation Visit in: DFS-SF subscale scores (leisure, physical health, dependence/daily life, negative emotions, worried about ulcers/feet, bother by ulcer care). DFS-SF subscale scoring * Five-point scale: 1=never to 5=all the time * Score is based on sum of all items * Scored 0-100 - higher scores indicate better QOL
Time frame
52 WeeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov