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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 is a Phase 2 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03135535
The ClinicalTrials.gov registry entry for NCT03135535 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Avex Footbeat is the first listed.
NCT03135535 reports 0 study locations.
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.
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