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AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries
NCT03463434 · View on ClinicalTrials.gov ↗
Study Summary
Patients who have at least one stage 3 or 4 PI and are admitted to a participating treating facility will be candidates for study enrollment. Patients must provide written informed consent. Standard care for their admitted condition will be provided for the patients except for support surface selection, laboratory blood tests, PI measurement(s) by the 3-D camera measurement tool, and added pain and patient satisfaction assessments. Clinical assessments will be recorded weekly as described below. Patients will be followed until discharge from the LTACH or until 1) they require a different mattress for their admitted condition; or 2) reach a maximum of 12 weeks in the LTACH. At study discontinuation, a clinical general assessment of the quality of improvement of the PIs will be recorded.
Conditions Studied
Interventions
- DEVICE Air Fluidized Therapy
- DEVICE Continuous Low Pressure-LAL
Study Locations (2)
Alabama
- Noland Health Anniston — Anniston
- Noland Health — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-05-10 |
| Est. Completion | 2019-08-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03463434
The ClinicalTrials.gov registry entry for NCT03463434 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hill-Rom, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pressure Ulcer appearing as the primary indexed condition, and to 2 interventions — of which Air Fluidized Therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03463434 reports 2 study locations spanning 1 distinct geographic area — top geographies include Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03463434 about?
NCT03463434 is a clinical study titled "AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries". Patients who have at least one stage 3 or 4 PI and are admitted to a participating treating facility will be candidates for study enrollment. Patients must provide written informed consent. Standard care for their admitted condition will be provided for the patients except for support surface select...
What is the current status of trial NCT03463434?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2018-05-10. Estimated completion is 2019-08-14.
What conditions does trial NCT03463434 study?
This clinical trial studies the following conditions: Pressure Ulcer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03463434?
The interventions under investigation include: Air Fluidized Therapy (DEVICE), Continuous Low Pressure-LAL (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03463434?
This trial is sponsored by Hill-Rom, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03463434 being conducted?
This trial has 2 study locations across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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