What side effects are associated with this type of intervention?

Common treatments for foot ulcers, such as advanced wound care technologies, compression therapy, and topical agents, can have several side effects. Advanced wound care technologies may cause local irritation or allergic reactions. Compression therapy can lead to discomfort, skin irritation, or even tissue damage if not applied correctly. Topical agents, including antimicrobial and anti-inflammatory creams, may cause skin irritation, allergic reactions, or contact dermatitis. It is important to monitor for these side effects and consult with a healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several advanced wound care technologies for the treatment of diabetic foot ulcers. These include various types of dressings, such as hydrocolloid, foam, and alginate dressings, which help maintain a moist wound environment conducive to healing. Additionally, topical agents like growth factors (e.g., becaplermin) and antimicrobial dressings have been approved to promote healing and prevent infection. Advanced therapies such as negative pressure wound therapy (NPWT) and bioengineered skin substitutes (e.g., Apligraf, Dermagraft) have also received FDA approval for their efficacy in treating chronic non-healing diabetic foot ulcers.

What other types of research exist?

Promising novel alternatives to Symphony™ for foot ulcer treatment include: 1) Topical application of growth factors such as platelet-derived growth factor (PDGF), 2) Use of bioengineered skin substitutes like Apligraf® and Dermagraft®, 3) Negative pressure wound therapy (NPWT), 4) Hyperbaric oxygen therapy (HBOT), and 5) Advanced dressings incorporating antimicrobial agents or promoting moist wound healing.

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Procedure

Symphony™ Treatment for Diabetic Foot Ulcers

N/A

Recruiting

Research Sponsored by Aroa Biosurgery Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years old, inclusive

Presence of a DFU, Wagner Grade 1 or 2 (see Appendix B for definitions), extending through the dermis provided it is below the medial aspect of the malleolus

Must not have

Index ulcer is overtly infected (i.e., purulent drainage)

History of radiation at the ulcer site (regardless of time since last radiation treatment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, generally treatments like Symphony™ may cause skin irritation or allergic reactions at the application site. Standard care dressings could also lead to similar local reactions or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a diabetic foot ulcer below my ankle.

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My largest foot ulcer will be the one studied, and any other ulcers are at least 2 cm away from it.

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My ulcer is between 1.0 and 25 cm2 in size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My wound is openly infected with pus.

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I have had radiation treatment at the site of my ulcer.

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My ulcer has not been treated with any forbidden treatments.

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My diabetes is not well-controlled, with an HbA1c over 12.0 recently.

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My kidney function is severely impaired with high creatinine levels.

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I have Charcot foot in my affected limb.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of index ulcers healed at 12 weeks

Secondary study objectives

Change in pain levels during the clinical investigation

Changes in wound quality of life (per W-QoL)

Percentage area reduction at 12 weeks

+1 more

Other study objectives

Cost to closure (both treatment groups; all wounds, and only closed wounds)

Product wastage (Symphony only)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for foot ulcers, especially advanced wound care technologies like Symphony™, work by maintaining a moist wound environment, which is essential for optimal healing. They also reduce bacterial load to prevent infections and promote tissue regeneration to repair damaged tissues. These mechanisms are vital for foot ulcer patients as they help speed up the healing process, minimize complications, and improve the chances of recovery.

Dressings and topical agents for arterial leg ulcers.