Wound HealingNCT06035523
Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™
A study testing Endoform™ Antibacterial, Endoform™ Natural and Symphony™ in people with Wound Healing and Diabetic Foot, run by Aroa Biosurgery Limited at 4 sites in United States.
Trial summary
Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing, Diabetic Foot, Chronic Foot Ulcer
- What is being tested?
- Endoform™ Antibacterial, Endoform™ Natural and Symphony™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Dec 2021to 30 Aug 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 D 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 SV1.
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
South Florida Lower Extremity Center
Hollywood, Florida, 33312
Advanced Pharma Cr, LLC
Miami, Florida, 33147
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, 24153
Madigan Army Medical Center
Tacoma, Washington, 98431-1100
About this study
Official title: A Single Arm Pilot Study Evaluating Wound Closure With a Unique Staged Application of Endoform™ and Symphony™ in the Treatment of Non-Healing Diabetic Foot Ulcers
Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.
Read the detailed description
About 50 subjects will take part in this study. The purpose of this study is to evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ (together, the 'Products') in the treatment of acute or chronic non-healing wounds, including diabetic foot ulcers Wagner Grade 1 or 2, after 12 weeks of treatment.
Following initial enrollment, eligible subjects will then undergo
- a treatment phase involving weekly treatment and evaluations for up to 12 weeks,
- subjects that heal will enter a follow-up period 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.
All subjects will require accepted routine procedures as part of standard of care (SOC): offloading of the DFU (removeable cast boot or total contact casting [TCC] if the subject's foot is too large for a removeable cast boot), appropriate sharp debridement, and infection management. In addition, each subject will receive a wound care covering comprising of either Endoform™ Antimicrobial, Endoform™ Natural or Symphony™ followed by 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 3-layer or equivalent).
- Conditions
- Wound Healing, Diabetic Foot, Chronic Foot Ulcer, Foot Ulcer
- Being tested
- Endoform™ Antibacterial, Endoform™ Natural, Symphony™
- Keywords
- Extracellular matrix, Regenerative medicine, Leg ulcer, Diabetes complications, Diabetic Angiopathies, Diabetes Mellitus
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Leg Ulcer, Diabetes Complications, Diabetic Angiopathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoform™ AntibacterialDevice
Application of Endoform™ Antibacterial
Endoform™ NaturalDevice
Application of Endoform™ Natural
Symphony™Device
Application of Symphony™
| Study group | Role | What they receive |
|---|---|---|
| Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer | Other | Arm receives application of Endoform™ Antibacterial, Endoform™ Natural and Symphony™ and appropriate Off - loading Receives: Device: Endoform™ Antibacterial; Device: Endoform™ Natural; Device: Symphony™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of index ulcers (the ulcers being treated in the study) 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 ulcers 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). Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
Measured: 12 weeks
Change in subjects reported pain levels (NPRS)
Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at baseline (Study Visit 1) and after 12 weeks of treatment EOS visit (End of Study 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 start29 Dec 2021
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT06035523
- Sponsor's protocol ID
- AROA 002
- Status last verified
- Oct 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 Single Arm Pilot Study Evaluating Wound Closure With a Unique Staged Application of Endoform™ and Symphony™ in the Treatment of Non-Healing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06035523
- Acronym / sponsor ID
- AROA 002
- Conditions
- Wound Healing, Diabetic Foot, Chronic Foot Ulcer, Foot Ulcer
- Keywords
- Extracellular matrix, Regenerative medicine, Leg ulcer, Diabetes complications, Diabetic Angiopathies, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Aroa Biosurgery LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 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.
Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.
Detailed description
About 50 subjects will take part in this study. The purpose of this study is to evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ (together, the 'Products') in the treatment of acute or chronic non-healing wounds, including diabetic foot ulcers Wagner Grade 1 or 2, after 12 weeks of treatment.
Following initial enrollment, eligible subjects will then undergo
- a treatment phase involving weekly treatment and evaluations for up to 12 weeks,
- subjects that heal will enter a follow-up period 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.
All subjects will require accepted routine procedures as part of standard of care (SOC): offloading of the DFU (removeable cast boot or total contact casting [TCC] if the subject's foot is too large for a removeable cast boot), appropriate sharp debridement, and infection management. In addition, each subject will receive a wound care covering comprising of either Endoform™ Antimicrobial, Endoform™ Natural or Symphony™ followed by 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 3-layer or equivalent).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer | Other | Device: Endoform™ Antibacterial, Device: Endoform™ Natural, Device: Symphony™Arm receives application of Endoform™ Antibacterial, Endoform™ Natural and Symphony™ 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 D 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 (14 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 |
|---|---|---|
| Endoform™ AntibacterialApplication of Endoform™ Antibacterial | Device | Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer |
| Endoform™ NaturalApplication of Endoform™ Natural | Device | Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer |
| Symphony™Application of Symphony™ | Device | Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer |
Primary outcome
Percentage of index ulcers (the ulcers being treated in the study) 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: 12 weeks
Change in subjects reported pain levels (NPRS)
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoform™ Antibacterial, Endoform™ Natural and Symphony™ in people with Wound Healing and Diabetic Foot, run by Aroa Biosurgery Limited at 4 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 14 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 4 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 (the ulcers being treated in the study) 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.