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Smart Boot for Diabetic Foot Ulcers
Phase 2
Recruiting
Led By David G Armstrong, DPN, MD, PhD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or Female aged 18 or older
Diabetic Foot Ulcer requiring offloading
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
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.
Who is the study for?
This trial is for adults with diabetic foot ulcers needing offloading. Participants must be able to consent and attend clinic visits, but can't join if they have long-standing wounds, very high HbA1c levels (>12%), poor blood flow in the limbs, bone/tendon-involved ulcers, non-diabetic ulcers or are wheelchair-bound.Check my eligibility
What is being tested?
The study compares three types of diabetic boots: a non-removable boot, a removable boot with adherence counseling, and a 'smart' boot that gives feedback via smart devices. It aims to see which helps patients follow wearing instructions best and improve healing.See study design
What are the potential side effects?
While not explicitly mentioned, potential side effects may include skin irritation from the boots or discomfort related to their use. The 'smart' boot might also cause privacy concerns due to data sharing with smart devices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a diabetic foot ulcer that needs pressure relief.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to offloading
Wound healing
Secondary outcome measures
Physical Activity
Speed of wound healing
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Smart boot removable+reinforcementExperimental Treatment1 Intervention
Smart boot with, removable, with reinforcement of adherence via smart watch and smart phone as well as remote patient monitoring.
Group II: Smart boot removableActive Control1 Intervention
Smart boot, removable, without feedback on adherence.
Group III: Smart boot irremovableActive Control1 Intervention
Smart boot rendered irremovable with cohesive bandage; no feedback on adherence.
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,028 Total Patients Enrolled
4 Trials studying Foot Ulcer
299 Patients Enrolled for Foot Ulcer
Baylor College of MedicineOTHER
1,001 Previous Clinical Trials
6,001,702 Total Patients Enrolled
5 Trials studying Foot Ulcer
118 Patients Enrolled for Foot Ulcer
David G Armstrong, DPN, MD, PhDPrincipal InvestigatorProfessor of Surgery, Keck School of Medicine of USC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Smart boot removable
- Group 2: Smart boot removable+reinforcement
- Group 3: Smart boot irremovable
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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