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COMPLETED NA

Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

NCT01048307 · View on ClinicalTrials.gov ↗

Study Summary

Objective: To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution Methodology: Randomised, controlled multi-centre, prospective clinical trial Planned number of subjects: 20 patients in experimental group (Prontosan® Wound Irrigation Solution) 8 patients in control group (wound irrigation with saline) Products under investigation: Prontosan® Wound Irrigation Solution Study Duration: 3-4 weeks

Interventions

  • DEVICE Prontosan wound irrigation solution

Study Locations (1)

New York

  • Calvary hospital center for curative and palliative wound care — The Bronx

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2009-06
Est. Completion 2010-07
Phase NA

Sponsor

Calvary Hospital, Bronx, NY

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01048307

The ClinicalTrials.gov registry entry for NCT01048307 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 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calvary Hospital, Bronx, NY, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Chronic Wound Care appearing as the primary indexed condition, and to 1 intervention — of which Prontosan wound irrigation solution 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: NCT01048307 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. 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 NCT01048307 about?

NCT01048307 is a clinical study titled "Effect of Prontosan Wound Irrigation Solution on Venous Ulcers". Objective: To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution Methodology: Randomised, controlled multi-centre, prospective clinical trial Planned number of subjects: 20...

What is the current status of trial NCT01048307?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2009-06. Estimated completion is 2010-07.

What conditions does trial NCT01048307 study?

This clinical trial studies the following conditions: Chronic Wound Care, Wound Care, Venous Ulcer Care, Wound Cleansing. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01048307?

The interventions under investigation include: Prontosan wound irrigation solution (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01048307?

This trial is sponsored by Calvary Hospital, Bronx, NY, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01048307 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial