Symphony™ Treatment for Diabetic Foot Ulcers

Recruiting in Palo Alto (17 mi)

+8 other 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.

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.

+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.

+12 more

Participant Groups

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.

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.