120 Participants Needed

Symphony™ Treatment for Diabetic Foot Ulcers

Recruiting at 9 trial locations
SC
FP
Overseen ByFrances Parker
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 6 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants receive weekly treatment and evaluations for up to 12 weeks with either Symphony™ or Standard of Care (SOC) treatment

12 weeks
12 visits (in-person)

Follow-up

Participants that heal undergo a follow-up phase that includes a Healing Confirmation Visit 2 weeks from initial healing

2 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Symphony™ plus Off-loading
  • Wound Dressing comprising of calcium alginate Fibracol
Trial Overview The 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+
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