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NCT06035536 · ClinicalTrials.gov registry record · NA
Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
A NA study of Diabetic Foot Ulcer and Diabetic Foot, sponsored by Aroa Biosurgery Limited.
- Completed
- Registry status
- NA
- Development phase
- 143
- Enrollment target
- 11
- Study locations
NCT06035536 is a NA study of Diabetic Foot Ulcer and Diabetic Foot that has completed, run by Aroa Biosurgery Limited. The registered enrollment target is 143 participants, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (43% lower). The trial reports 11 study locations across 8 states.
The verdict
NCT06035536, a NA study of Diabetic Foot Ulcer and Diabetic Foot, has completed, sponsored by Aroa Biosurgery Limited.
- COMPLETED
- Registry status
- NA
- Development phase
- 143 participants
- Enrollment target
- 11
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2023-06-08 |
| Est. Completion | 2025-11-03 |
| Phase | NA |
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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, categorized as NA. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (43% lower). The listed sponsor is Aroa Biosurgery Limited, which has 4 total studies on file at ClinicalTrials.gov.
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.
NCT06035536 reports 11 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, New Jersey.
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.
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).
Who is sponsoring clinical trial NCT06035536?
This trial is sponsored by Aroa Biosurgery Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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