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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: Completed NA study of Diabetic Foot Ulcer and Diabetic Foot, sponsored by Aroa Biosurgery Limited.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks
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 |
What the finished NCT06035536 record still lists
NCT06035536 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (43% lower).
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 lists 11 locations in 8 states (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
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06035536's enrollment target sits among peer trials
143 27th of 67 higher than 41 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
RECRUITING · NA
-
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
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-
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
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-
Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
RECRUITING · NA
-
Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
RECRUITING · NA
-
Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
RECRUITING · NA
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