Smart Boot Use to Measure Offloading Adherence
Recruiting
Phase 2
Interventional Study
Diabetic Foot Ulcer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 210 (estimated)
- Sponsor
- University of Southern California · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kin…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
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 Criteria:
* Wound present for \> 1 year
* HbA1c \> 12%
* ABI of index limb \<…
Contacts