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COMPLETED NA

Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

NCT06035536 · View on ClinicalTrials.gov ↗

Study Summary

The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.

Interventions

  • DEVICE Symphony™ plus Off-loading
  • DEVICE Wound Dressing comprising of calcium alginate Fibracol

Study Locations (11)

California

  • LA Foot and Ankle — Los Angeles
  • Clemente Clinical Research Inc. — Los Angeles
  • Bay Area Foot Care — San Francisco

Florida

  • Doctor's Research Network — Miami
  • Barry University Clinical Research — Tamarac

New Jersey

  • Curalta Foot and Ankle — Westwood

North Carolina

  • Foot and Ankle Specialists of the Mid-Atlantic — Gastonia

Ohio

  • Lower Extremity Institute for Research and Therapy — Boardman

Pennsylvania

  • Martin Foot and Ankle — York

Texas

  • Perfizien Clinical Research — Houston

Virginia

  • Foot and Ankle Specialists of the Mid-Atlantic — Salem

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2023-06-08
Est. Completion 2025-11-03
Phase NA

Sponsor

Aroa Biosurgery Limited

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06035536

The ClinicalTrials.gov registry entry for NCT06035536 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 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aroa Biosurgery Limited, 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 4 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 2 interventions — of which Symphony™ plus Off-loading 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: NCT06035536 reports 11 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, New Jersey. 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 NCT06035536 about?

NCT06035536 is a clinical study titled "Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers". The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.

What is the current status of trial NCT06035536?

This trial is currently completed. It is a NA study. The enrollment target is 143 participants. The study started on 2023-06-08. Estimated completion is 2025-11-03.

What conditions does trial NCT06035536 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer, Chronic Foot 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 NCT06035536?

The interventions under investigation include: Symphony™ plus Off-loading (DEVICE), Wound Dressing comprising of calcium alginate Fibracol (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06035536?

This trial is sponsored by Aroa Biosurgery Limited, 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 NCT06035536 being conducted?

This trial has 11 study locations across California, Florida, New Jersey, North Carolina, Ohio. 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