Diabetic FootNCT06035536
Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
A study testing Symphony™ plus Off-loading and Wound Dressing comprising of calcium alginate Fibracol in people with Diabetic Foot and Diabetic Foot Ulcer, run by Aroa Biosurgery Limited at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer
- What is being tested?
- Symphony™ plus Off-loading and Wound Dressing comprising of calcium alginate Fibracol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 11 sitesUnited States
- Study dates
- 8 Jun 2023to 3 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. At least 18 years old, inclusive.
- 2. 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.
- 3. 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.
- 4. 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.
- 5. Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
- 6. 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.
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- 7. The target ulcer has been offloaded for at least 14 days, prior to TV1.
- 8. 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.
- 9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
- 10. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.
Who cannot join
- 1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
- 2. 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
- 3. Index ulcer is overtly infected (i.e., purulent drainage)
- 4. 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
- 5. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1
- 6. History of radiation at the ulcer site (regardless of time since last radiation treatment)
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- 7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies
- 8. Subjects with a previous diagnosis of HIV or Hepatitis C
- 9. 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
- 10. 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)
- 11. Subject is pregnant or breast-feeding
- 12. Presence of diabetes with poor metabolic control as documented with an HbA1c >12.0 within last 90 days
- 13. Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
- 14. Presence of acute Charcot Neuroarthropathy to the affected limb
- 15. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Lower Extremity Institute for Research and Therapy
Boardman, Ohio, 44512
Foot and Ankle Specialists of the Mid-Atlantic
Gastonia, North Carolina, 28054
Perfizien Clinical Research
Houston, Texas, 77055
LA Foot and Ankle
Los Angeles, California, 90010
Clemente Clinical Research Inc.
Los Angeles, California, 90033
Doctor's Research Network
Miami, Florida, 33143
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, 24153
Bay Area Foot Care
San Francisco, California, 94115
Barry University Clinical Research
Tamarac, Florida, 33321
Curalta Foot and Ankle
Westwood, New Jersey, 07675
Martin Foot and Ankle
York, Pennsylvania, 17402
About this study
Official title: A Multi-Center, Randomized Controlled Clinical Investigation Evaluating Wound Closure With Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
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.
Read the detailed description
About 120 subjects will take part in this study. Subjects with a Wagner Grade 1 or 2 Diabetic Foot Ulcers will be randomized at a ratio of 1:1 to one of the two treatment groups at the time of completion of screening to either Symphony™ treatment or Standard of Care (SOC) treatment groups.
Following initial enrolment, eligible subjects will then undergo:
- A screening phase consisting of 14 days to determine eligibility.
- Eligible subjects will then undergo a treatment phase involving weekly treatment and evaluations for up to 12 weeks.
- Subjects that heal will undergo a follow-up phase that includes 1 visit (Healing Confirmation Visit), 2 weeks from initial healing.
- If the subject does not heal, they will exit at Week 13, End of Study visit.
Both treatment groups will receive accepted routine procedures being part of SOC, including offloading of the DFU (removable cast boot or total contact casting [TCC] if the subject's foot is too large for a removable cast boot), appropriate sharp or surgical debridement, and infection management.
In addition to what is noted above, Group 1 will receive a weekly application of Symphony™ and Group 2 will receive SOC comprising of calcium alginate Fibracol dressing. Both Groups will have a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3layer or equivalent) applied.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Chronic Foot Ulcer
- Being tested
- Symphony™ plus Off-loading, Wound Dressing comprising of calcium alginate Fibracol
- Keywords
- Extracellular matrix, Regenerative medicine, Leg ulcer, Diabetes Mellitus, Diabetic Angiopathies, Diabetes Complications
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Leg Ulcer, Diabetes Mellitus, Diabetic Angiopathies, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symphony™ plus Off-loadingDevice
Application of Symphony™
Wound Dressing comprising of calcium alginate FibracolDevice
Application of Wound Dressing comprising of calcium alginate Fibracol.
| Study group | Role | What they receive |
|---|---|---|
| Symphony™ treatment | Experimental | Arm receives an application of Symphony™ treatment and appropriate Off-loading. Receives: 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. Receives: Device: Wound Dressing comprising of calcium alginate Fibracol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of index ulcers healed at 12 weeks
Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks
Measured: 12 weeks
Secondary outcomes (4)
Time to heal within 12 weeks
Time to heal of index ulcer defined as 100% re-epithelialization within 12 weeks
Measured: 12 weeks
Percentage area reduction at 12 weeks
Area reduction percentage of ulcer at 12 weeks
Measured: 12 weeks
Changes in wound quality of life (per W-QoL)
Changes in wound quality of life (W-QoL) using the W-QoL short questionnaire administered on Study Visit 1 (as a baseline) and after 12 weeks of treatment (End of Study Visit) normalized to a single value. Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
Measured: after 12 weeks
Change in pain levels during the clinical investigation
Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at each weekly visit. On the numerical pain scale, the number 0 represents "no pain" and the number 10 represents "the worst possible pain".
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start8 Jun 2023
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aroa Biosurgery Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Responsible party
- Sponsor
- Investigators
- David Armstrong, DPM, MD PhD, Study chair, Keck School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035536
- Sponsor's protocol ID
- AROA 003
- Status last verified
- Jul 2025
- First submitted
- 23 Aug 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized Controlled Clinical Investigation Evaluating Wound Closure With Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06035536
- Acronym / sponsor ID
- AROA 003
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Chronic Foot Ulcer
- Keywords
- Extracellular matrix, Regenerative medicine, Leg ulcer, Diabetes Mellitus, Diabetic Angiopathies, Diabetes Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Aroa Biosurgery LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
About 120 subjects will take part in this study. Subjects with a Wagner Grade 1 or 2 Diabetic Foot Ulcers will be randomized at a ratio of 1:1 to one of the two treatment groups at the time of completion of screening to either Symphony™ treatment or Standard of Care (SOC) treatment groups.
Following initial enrolment, eligible subjects will then undergo:
- A screening phase consisting of 14 days to determine eligibility.
- Eligible subjects will then undergo a treatment phase involving weekly treatment and evaluations for up to 12 weeks.
- Subjects that heal will undergo a follow-up phase that includes 1 visit (Healing Confirmation Visit), 2 weeks from initial healing.
- If the subject does not heal, they will exit at Week 13, End of Study visit.
Both treatment groups will receive accepted routine procedures being part of SOC, including offloading of the DFU (removable cast boot or total contact casting [TCC] if the subject's foot is too large for a removable cast boot), appropriate sharp or surgical debridement, and infection management.
In addition to what is noted above, Group 1 will receive a weekly application of Symphony™ and Group 2 will receive SOC comprising of calcium alginate Fibracol dressing. Both Groups will have a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3layer or equivalent) applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symphony™ treatment | Experimental | Device: Symphony™ plus Off-loadingArm receives an application of Symphony™ treatment and appropriate Off-loading. |
| Standard of Care (SOC) treatment | Active comparator | Device: Wound Dressing comprising of calcium alginate FibracolArm receives an application of SOC comprising of calcium alginate Fibracol dressing and appropriate Off-loading. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. At least 18 years old, inclusive.
- 2. 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.
- 3. 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.
- 4. 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.
- 5. Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
Key exclusion criteria (15 listed)
- 1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
- 2. 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
- 3. Index ulcer is overtly infected (i.e., purulent drainage)
- 4. 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
- 5. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symphony™ plus Off-loadingApplication of Symphony™ | Device | Symphony™ treatment |
| Wound Dressing comprising of calcium alginate FibracolApplication of Wound Dressing comprising of calcium alginate Fibracol. | Device | Standard of Care (SOC) treatment |
Primary outcome
Percentage of index ulcers healed at 12 weeks
Time frame: 12 weeks
Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks
4 secondary outcomes
Time to heal within 12 weeks
Time frame: 12 weeks
Percentage area reduction at 12 weeks
Time frame: 12 weeks
Changes in wound quality of life (per W-QoL)
Time frame: after 12 weeks
Change in pain levels during the clinical investigation
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Armstrong, DPM, MD PhD study chair
Keck School of Medicine
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symphony™ plus Off-loading and Wound Dressing comprising of calcium alginate Fibracol in people with Diabetic Foot and Diabetic Foot Ulcer, run by Aroa Biosurgery Limited at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of index ulcers healed at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.