Symphony™ Treatment for Diabetic Foot Ulcers
Trial Summary
What is the purpose of this trial?
This trial will test Symphony™, a special wound treatment, on patients with chronic diabetic foot ulcers that don't heal with regular care. The treatment helps wounds heal faster by providing extra support.
Research Team
David Armstrong, DPM, MD PhD
Principal Investigator
Keck School of Medicine
Eligibility Criteria
Adults with chronic non-healing diabetic foot ulcers present for more than 4 weeks but less than a year, who have offloaded the ulcer for at least 14 days and have adequate circulation to the affected foot. They must understand and comply with study requirements, including weekly visits, and use contraception if of childbearing potential. Exclusions include pregnancy, breastfeeding, suspected cancerous ulcers, overt infection or recent immune-suppressant use.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly treatment and evaluations for up to 12 weeks with either Symphony™ or Standard of Care (SOC) treatment
Follow-up
Participants that heal undergo a follow-up phase that includes a Healing Confirmation Visit 2 weeks from initial healing
Treatment Details
Interventions
- Symphony™ plus Off-loading
- Wound Dressing comprising of calcium alginate Fibracol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aroa Biosurgery Limited
Lead Sponsor
Professional Education and Research Institute
Collaborator