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Smart Boot for Diabetic Foot Ulcers
Study Summary
This trial will help researchers understand if using technology to help people with diabetes follow their treatment plan for neuropathic foot ulcers will help the ulcers heal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My blood flow in the legs is low, indicated by an ABI test result of less than 0.9.I have had a wound for over a year.Your HbA1c level is higher than 12%.I cannot or do not want to go to all the clinic visits.My ulcer is not due to diabetes.I use a wheelchair for all my mobility needs.I am 18 years old or older.I have a diabetic foot ulcer that needs pressure relief.I have an ulcer that affects my bone or tendon.
- Group 1: Smart boot removable
- Group 2: Smart boot removable+reinforcement
- Group 3: Smart boot irremovable
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the aggregate tally of individuals taking part in this research endeavor?
"Affirmative. Clinicaltrials.gov attests to this medical study's active recruitment, which began on October 19th 2021 and was last revised on October 18th 2022. The research seeks 250 participants between 2 sites."
Has the FDA sanctioned Boot for use in healthcare?
"The safety of Boot was given a rating of 2, as there is evidence that it can be tolerated but no clinical proof for its efficacy."
Does this trial offer enrollment opportunities at present?
"According to the information provided on clinicaltrials.gov, this scientific investigation is actively searching for participants. The original posting of this trial happened on October 19th 2021 and was most recently amended on October 18th 2022."
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