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New treatment option for Diabetic Foot Ulcer
Official title Smart Boot Use to Measure Offloading Adherence
ClinicalTrials.gov ID: NCT04460573
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Wound present for \> 1 year
- HbA1c \> 12%
- ABI of index limb \< 0.6 or non-detectable Doppler, and/or patient being considered for revascularization during the course of the study
- Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wear the smart boot
- Amputation proximal to the rearfoot on the affected extremity
- Any clinically significant medical or psychiatric condition
See the full eligibility 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
- Wound present for \> 1 year
- HbA1c \> 12%
- ABI of index limb \< 0.6 or non-detectable Doppler, and/or patient being considered for revascularization during the course of the study
- Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wear the 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 the study
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Downey, California, United States
- Glendale, California, United States
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Downey, California, United States; Glendale, California, United States; Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.