Symphony™ Treatment for Diabetic Foot Ulcers

Recruiting at 4 trial locations

Overseen By Frances Parker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aroa Biosurgery Limited

Must not be taking: Immune-suppressants, Chemotherapy, Topical steroids, others

Disqualifiers: HIV, Hepatitis C, Poor metabolic control, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Symphony™ treatment for diabetic foot ulcers, which are stubborn wounds that resist healing. Researchers aim to compare the effectiveness of Symphony™ with usual care after 12 weeks. Participants will receive either the new Symphony™ treatment or standard care to compare outcomes. This trial suits individuals with a diabetic foot ulcer that hasn't healed in over a month but is not older than a year. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future treatment options.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been on immune-suppressants, certain chemotherapy drugs, or topical steroids recently. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Symphony™ treatment is safe for diabetic foot ulcers?

Research has shown that the Symphony™ treatment for diabetic foot ulcers is safe. In an earlier study, patients using Symphony™ experienced a noticeable decrease in the size and depth of their wounds. Importantly, the study found that the treatment was well-tolerated, with no major side effects. This suggests that Symphony™ could be a promising option for those with diabetic foot ulcers that are not healing. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for diabetic foot ulcers?

Unlike the standard care for diabetic foot ulcers, which typically involves dressings like calcium alginate and physical off-loading, the Symphony™ treatment offers a novel approach by integrating its unique treatment method with off-loading. Researchers are excited because Symphony™ might enhance healing by potentially improving how the body restores itself, although its specific mechanism is still under investigation. This new approach could lead to faster and more effective healing compared to the conventional methods currently available.

What evidence suggests that Symphony™ is effective for diabetic foot ulcers?

Research shows that the Symphony™ treatment, used with off-loading (reducing pressure on the foot), may help heal diabetic foot ulcers. Studies have found that products like Symphony™ aid wound healing by promoting new tissue growth, allowing the skin to heal and close more quickly. Early findings suggest that patients using Symphony™ treatment experienced better and faster healing compared to those receiving the standard of care, which involves a calcium alginate Fibracol dressing with off-loading. While more research is needed, these initial results are promising for those with difficult-to-heal diabetic foot ulcers. ^{1 3 6 7 8}

Who Is on the Research Team?

David Armstrong, DPM, MD PhD

Principal Investigator

Keck School of Medicine

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Symphony™ treatment Experimental Treatment 1 Intervention

Arm receives an application of Symphony™ treatment and appropriate Off-loading.

Group II: Standard of Care (SOC) treatment Active Control 1 Intervention

Arm receives an application of SOC comprising of calcium alginate Fibracol dressing and appropriate Off-loading.

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06035536?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(Diabetic%20Foot%20Ulcer))&rank=6

Clinical Study Evaluating Symphony™ Versus Standard of ... 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) ...

2. withpower.com withpower.com/trial/phase-diabetic-foot-11-2021-9fcfa

Endoform + Symphony for Diabetic Foot Ulcers This trial tests special wound care products on patients with hard-to-heal diabetic foot ulcers. These products help wounds heal by supporting tissue growth ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11676782/

An Overview of Recent Clinical Trials for Diabetic Foot Ulcer ... The results showed that allo-hBM-MSC-treated wounds exhibited greater closure, enhanced skin regeneration, and faster healing than the control ...

4. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39756&ver=7

LCD - Skin Substitute Grafts/Cellular and Tissue-Based ... The efficacy and safety of Grafix for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial.

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0124704

Diabetic Foot Ulcers (DFUs) (DBCOND0124704) Efficacy and Safety Evaluation of the Intralesional Recombinant Human Epidermal Growth Factor (rhEGF) in Subjects With Diabetic Foot Ulcer. Nepidermin.

6. ctv.veeva.com ctv.veeva.com/study/randomized-clinical-study-evaluating-symphony-versus-standard-of-care-in-the-treatment-of-non-heali

Clinical Study Evaluating Symphony™ Versus Standard of ... The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic ...

7. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=39865

Skin Substitute Grafts/Cellular and Tissue-Based Products ... Overall, the results show that substantially more ulcers healed when treated with bilayer artificial skin than with dressings. There was inadequate evidence ...

8. go.drugbank.com go.drugbank.com/conditions/DBCOND0146465

Foot, Diabetic (DBCOND0146465) NCT06035536. Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers, No drug interventions, treatment ...