Symphony™ Treatment for Diabetic Foot Ulcers
Recruiting at8 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Aroa Biosurgery Limited
No Placebo Group
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
DA
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
My ulcer has been present for more than 4 weeks but less than a year.
I have a diabetic foot ulcer below my ankle.
My largest foot ulcer will be the one studied, and any other ulcers are at least 2 cm away from it.
See 7 more
Exclusion Criteria
I haven't used strong immune-suppressants or chemotherapy for my condition in the last month.
My ulcer has not been treated with any forbidden treatments.
My ulcer is not caused by diabetes.
See 12 more
Treatment Details
Interventions
- Symphony™ plus Off-loading (Procedure)
- Wound Dressing comprising of calcium alginate Fibracol (Procedure)
Trial OverviewThe trial is testing Symphony™ combined with off-loading against standard wound dressing (calcium alginate Fibracol) in healing diabetic foot ulcers over a period of 12 weeks. The goal is to assess which treatment is safer and more effective in managing these chronic wounds.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Symphony™ treatmentExperimental Treatment1 Intervention
Arm receives an application of Symphony™ treatment and appropriate Off-loading.
Group II: Standard of Care (SOC) treatmentActive Control1 Intervention
Arm receives an application of SOC comprising of calcium alginate Fibracol dressing and appropriate Off-loading.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aroa Biosurgery Limited
Lead Sponsor
Trials
3
Recruited
970+
Professional Education and Research Institute
Collaborator
Trials
16
Recruited
1,400+