Phase
Condition
Pressure Ulcer
Diabetes Mellitus Types I And Ii
Ulcers
Treatment
Offloading Boot
Boot
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female
≥18 years old
Non-infected, non-ischemic DFU requiring offloading
Ambulatory at home with or without assistance
Willing and able to provide written informed consent
Exclusion
Exclusion Criteria:
Wound present for > 1 year
HbA1c > 12%
ABI of index limb < 0.6 or non-detectable Doppler, and/or patient being consideredfor revascularization during the course of the study
Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wearthe smart boot
Amputation proximal to the rearfoot on the affected extremity
Any clinically significant medical or psychiatric condition
Laboratory abnormality that would interfere with the ability to participate in thestudy
Concurrently participating in exercise training
Changes in psychotropic or sleep medication in the last 6 weeks
Ulcer involves bone
Ulcer not of diabetic origin
Unable or unwilling to attend prescribed clinic visits or comply with protocol
Study Design
Connect with a study center
Rancho Los Amigos National Rehabilitation Center
Downey, California 90242
United StatesSite Not Available
Verdugo Hills Hospital of USC
Glendale, California 91208
United StatesSite Not Available
Clemente Clinical Research
Los Angeles, California 90033
United StatesSite Not Available
Keck Medical Center of USC
Los Angeles, California 90033
United StatesActive - Recruiting
Rancho Los Amigos National Rehabilitation Center
Downey 5343858, California 5332921 90242
United StatesActive - Recruiting
Verdugo Hills Hospital of USC
Glendale 5352423, California 5332921 91208
United StatesActive - Recruiting
Clemente Clinical Research
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting
Keck Medical Center of USC
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting

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