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NCT02783066 · ClinicalTrials.gov registry record · Phase 2
Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study
A Phase 2 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT02783066 is a Phase 2 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 16 participants.
The verdict
NCT02783066, a Phase 2 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes. 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, resulting in staggering costs for both the patient and the healthcare system. Prevention by identifying people at higher risk is key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or 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 possibility of gangrene. A novel low voltage, battery powered medical device, PulseFlow DF® (The Diabetic Boot Company, Ltd. UK) has endeavored to assist in the treatment of Diabetic Foot Ulcers. The device provides hybrid functionality i.e. mobile air bladder pump at plantar arch and offloading boot. The air bladder inflates to 160 mmHg for approx. 1 second then deflates back to atmospheric pressure, allowing the plantar vessels sufficient time to refill. The offloading boot design holds the foot and lower leg in a position that reduces shear and friction forces and provides a reduction in plantar pressure. The PulseFlow DF is designed to record how many hours of blood pumping it has delivered. This data will be downloaded at each clinic visit. The boot cannot pump blood around the participant's foot unless fitted correctly and the battery is charged up overnight. The purpose of this study is to conduct an interventional study study with N=15 diabetic subjects with active foot ulcers to assess whether PulseFlow foot compression device can help improve lower extremity perfusion
Interventions
- DEVICE Offloading boot: PulseFlow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-10-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02783066
The ClinicalTrials.gov registry entry for NCT02783066 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 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 Offloading boot: PulseFlow is the first listed.
NCT02783066 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02783066 about?
NCT02783066 is a clinical study titled "Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study". Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes. 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 o...
What is the current status of trial NCT02783066?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2016-01. Estimated completion is 2019-10-30.
What interventions are being tested in trial NCT02783066?
The interventions under investigation include: Offloading boot: PulseFlow (DEVICE).
Who is sponsoring clinical trial NCT02783066?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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