Status:
TERMINATED
Diabetic Foot Ulcer Recurrence: Pilot Study
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Stanford University
Conditions:
Diabetic Foot
Ulcer Foot
Eligibility:
All Genders
18+ years
Brief Summary
In this prospective pilot study, patients with DFU visiting the Indiana University Comprehensive Wound Center will be enrolled. Patients enrolled in the study will be followed for 16 weeks for wound c...
Detailed Description
Diabetes impairs immune defenses such that the ability to fight wound infection is weakened. Thus, infection is a major problem in diabetic foot ulcers (DFUs) . Biofilms are estimated to account for 6...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Willing to comply with protocol instructions, including all study visits and study activities.
- Diabetic foot ulcers
- Adequate arterial blood flow as evidenced by at least one of the following:
- TCOM \> 30 mmHg
- Ankle-brachial index ≥0.7
- Toe pressure \> 30 mmHg
Exclusion
- Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent)
- Wounds closed or to be closed by flap or graft coverage
- Prisoners
Key Trial Info
Start Date :
January 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03479242
Start Date
January 25 2019
End Date
August 30 2023
Last Update
October 23 2023
Active Locations (1)
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1
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202