Status:
RECRUITING
Smart Boot Use to Measure Offloading Adherence
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Baylor College of Medicine
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation. Part of ...
Eligibility Criteria
Inclusion
- Male or Female aged 18 or older
- Diabetic Foot Ulcer requiring offloading
- Able to provide written informed consent
Exclusion
- Wound present for more than one year
- HbA1c \> 12%
- Ankle Brachial Index (ABI) of index limb is \<0.9 and/or they are being considered for revascularization within the course of the study
- Ulcer involving bone or tendon
- Ulcer not caused by diabetes
- Unable or unwilling to attend prescribed clinic visits
- Fully confined to a wheelchair
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04460573
Start Date
October 19 2021
End Date
December 31 2025
Last Update
October 8 2024
Active Locations (4)
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1
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
2
Verdugo Hills Hospital of USC
Glendale, California, United States, 91208
3
Clemente Clinical Research
Los Angeles, California, United States, 90033
4
Keck Medical Center of USC
Los Angeles, California, United States, 90033