NCT06035536

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

A Multi-Center, Randomized Controlled Clinical Investigation Evaluating Wound Closure With Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Aroa Biosurgery Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

About 120 subjects will take part in this study. Subjects with a Wagner Grade 1 or 2 Diabetic Foot Ulcers will be randomized at a ratio of 1:1 to one of the two treatment groups at the time of completion of screening to either Symphony™ treatment or Standard of Care (SOC) treatment groups. Following initial enrolment, eligible subjects will then undergo: * A screening phase consisting of 14 days to determine eligibility. * Eligible subjects will then undergo a treatment phase involving weekly treatment and evaluations for up to 12 weeks. * Subjects that heal will undergo a follow-up phase that includes 1 visit (Healing Confirmation Visit), 2 weeks from initial healing. * If the subject does not heal, they will exit at Week 13, End of Study visit. Both treatment groups will receive accepted routine procedures being part of SOC, including offloading of the DFU (removable cast boot or total contact casting \[TCC\] if the subject's foot is too large for a removable cast boot), appropriate sharp or surgical debridement, and infection management. In addition to what is noted above, Group 1 will receive a weekly application of Symphony™ and Group 2 will receive SOC comprising of calcium alginate Fibracol dressing. Both Groups will have a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3layer or equivalent) applied.

Conditions

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Chronic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Symphony™ plus Off-loading	Application of Symphony™
DEVICE	Wound Dressing comprising of calcium alginate Fibracol	Application of Wound Dressing comprising of calcium alginate Fibracol.

Timeline

• Start date: 2023-06-08
• Primary completion: 2025-11-03
• Completion: 2025-11-03
• First posted: 2023-09-13
• Last updated: 2026-01-28

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study