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

NCT06035536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2026-01-28

No results posted yet for this 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

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

Interventions

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.

Sponsors & Collaborators

  • Professional Education and Research Institute

    collaborator OTHER

  • Aroa Biosurgery Limited

    lead INDUSTRY

Principal Investigators

  • David Armstrong, DPM, MD PhD · Keck School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2025-11-03
Completion
2025-11-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06035536 on ClinicalTrials.gov