Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

NCT06035536 | Completed DMC FDA Device

• 1 other identifier: AROA 003
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 11

Brief Summary

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) after 12 weeks of treatment.

Conditions

Diabetic Foot; Diabetic Foot Ulcer; Foot Ulcer; Chronic Foot Ulcer

Keywords

Extracellular matrix; Regenerative medicine; Leg ulcer; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications

Outcome Measures

Primary Outcomes (1)

• Percentage of index ulcers healed at 12 weeks

  Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks

  12 weeks

Secondary Outcomes (4)

• Time to heal within 12 weeks

  12 weeks

• Percentage area reduction at 12 weeks

  12 weeks

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

  after 12 weeks

• Change in pain levels during the clinical investigation

  12 weeks

Other Outcomes (2)

• Product wastage (Symphony only)

  12 weeks

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

  12 weeks

Study Arms (2)

Symphony™ treatment

EXPERIMENTAL

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

Device: Symphony™ plus Off-loading

Standard of Care (SOC) treatment

ACTIVE COMPARATOR

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

Device: Wound Dressing comprising of calcium alginate Fibracol

Interventions

Symphony™ plus Off-loading DEVICE

Application of Symphony™

Symphony™ treatment

Wound Dressing comprising of calcium alginate Fibracol DEVICE

Application of Wound Dressing comprising of calcium alginate Fibracol.

Standard of Care (SOC) treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
• \. Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
• \. Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
• \. Within 3 months of SV1, adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable.
• \. The target ulcer has been offloaded for at least 14 days, prior to TV1.
• \. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
• \. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
• \. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.

You may not qualify if:

• \. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
• \. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
• \. Index ulcer is overtly infected (i.e., purulent drainage)
• \. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study
• \. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1
• \. History of radiation at the ulcer site (regardless of time since last radiation treatment)
• \. Index ulcer has been previously treated or will need to be treated with any prohibited therapies
• \. Subjects with a previous diagnosis of HIV or Hepatitis C
• \. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment
• \. Osteomyelitis or bone infection of the affected foot as verified by xray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision)
• \. Subject is pregnant or breast-feeding
• \. Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days
• \. Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
• \. Presence of acute Charcot Neuroarthropathy to the affected limb
• \. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit

Sponsors & Collaborators

• Aroa Biosurgery Limited: lead
• Professional Education and Research Institute: collaborator

Study Sites (11)

LA Foot and Ankle

Los Angeles, California, 90010, United States

Location

Clemente Clinical Research Inc.

Los Angeles, California, 90033, United States

Location

Bay Area Foot Care

San Francisco, California, 94115, United States

Location

Doctor's Research Network

Miami, Florida, 33143, United States

Location

Barry University Clinical Research

Tamarac, Florida, 33321, United States

Location

Curalta Foot and Ankle

Westwood, New Jersey, 07675, United States

Location

Foot and Ankle Specialists of the Mid-Atlantic

Gastonia, North Carolina, 28054, United States

Location

Lower Extremity Institute for Research and Therapy

Boardman, Ohio, 44512, United States

Location

Martin Foot and Ankle

York, Pennsylvania, 17402, United States

Location

Perfizien Clinical Research

Houston, Texas, 77055, United States

Location

Foot and Ankle Specialists of the Mid-Atlantic

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; Leg Ulcer; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David Armstrong, DPM, MD PhD

  Keck School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 13, 2023
• Study Start: June 8, 2023
• Primary Completion: November 3, 2025
• Study Completion: November 3, 2025
• Last Updated: January 28, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)