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NCT03135535 · ClinicalTrials.gov registry record · Phase 2
Micro-mobile Foot Compression and Diabetic Foot
A Phase 2 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT03135535: Completed Phase 2 study, sponsored by Baylor College of Medicine.
NCT03135535 is a Phase 2 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03135535, a Phase 2 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb.Prevention by identifying people at higher risk is the key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and the possible resulting gangrene. A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative means providing lower extremity compression. This device is portable and can be used in a standard diabetic shoes on daily basis, which in turn may improve venous blood and relief from concomitant lower extremity edema. In addition, potential improvement in lower extremity blood flow in response to regular foot compression, could improve balance, gait, skin perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken steps per day, duration of standing, etc). The purpose of this study is to conduct an observational study with N=30 ambulatory patients with diabetes and loss of protective sensation to assess whether this micro-mobile foot compression device can help improving motor function, lower extremity perfusion, and vascular health.
Primary Outcome
Balance will be quantified by measuring body sway in medial-lateral direction using a validated wearable sensors technology (Balansens, Biosensics LLC) and body sway change after 4-weeks of daily use of AVEX Footbeat will be assessed compare to baseline. Th unit of measurement is cm.
Interventions
- DEVICE Avex Footbeat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-05-02 |
| Est. Completion | 2021-05-14 |
| Phase | Phase 2 |
What the finished NCT03135535 record still lists
NCT03135535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Avex Footbeat is the first listed.
NCT03135535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03135535 about?
NCT03135535 is a clinical study titled "Micro-mobile Foot Compression and Diabetic Foot". Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affect...
What is the current status of trial NCT03135535?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2017-05-02. Estimated completion is 2021-05-14.
What interventions are being tested in trial NCT03135535?
The interventions under investigation include: Avex Footbeat (DEVICE).
Who is sponsoring clinical trial NCT03135535?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03135535's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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