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

December 18, 2023 updated by: Aroa Biosurgery Limited

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90010
        • Recruiting
        • LA Foot and Ankle
        • Contact:
        • Principal Investigator:
          • Felix Sigal, DPM
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Clemente Clinical Research Inc.
        • Contact:
          • Stanley Mathis, DPM
          • Phone Number: 949-412-8445
      • San Francisco, California, United States, 94115
        • Recruiting
        • Bay Area Foot Care
        • Contact:
        • Principal Investigator:
          • Alex Reyzelman, DPM
    • Florida
      • Miami, Florida, United States, 33143
        • Recruiting
        • Doctor's Research Network
        • Principal Investigator:
          • Jason Hanft
        • Contact:
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Barry University Clinical Research
        • Contact:
        • Principal Investigator:
          • Robert Snyder, DPM
    • New Jersey
      • Westwood, New Jersey, United States, 07675
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Foot and Ankle Specialists of the Mid-Atlantic
        • Contact:
        • Principal Investigator:
          • Ryan Meredith, DPM
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Recruiting
        • Lower Extremity Institute for Research and Therapy
        • Contact:
        • Principal Investigator:
          • Lawrence A DiDomenico, DPM
    • Pennsylvania
      • York, Pennsylvania, United States, 17402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symphony™ treatment
Arm receives an application of Symphony™ treatment and appropriate Off-loading.
Device: Symphony™ plus Off-loading
Application of Symphony™
Active Comparator: Standard of Care (SOC) treatment
Arm receives an application of SOC comprising of calcium alginate Fibracol dressing and appropriate Off-loading.
Device: Wound Dressing comprising of calcium alginate Fibracol
Application of Wound Dressing comprising of calcium alginate Fibracol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of index ulcers healed at 12 weeks
Time Frame: 12 weeks
Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to heal within 12 weeks
Time Frame: 12 weeks
Time to heal of index ulcer defined as 100% re-epithelialization within 12 weeks
12 weeks
Percentage area reduction at 12 weeks
Time Frame: 12 weeks
Area reduction percentage of ulcer at 12 weeks
12 weeks
Changes in wound quality of life (per W-QoL)
Time Frame: after 12 weeks
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).
after 12 weeks
Change in pain levels during the clinical investigation
Time Frame: 12 weeks
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".
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Product wastage (Symphony only)
Time Frame: 12 weeks
Product wastage (applies only to DFUs treated with Symphony). Area of Symphony device; wound area at time of application based on digital planimetry imaging of area. Percentage wastage: (Area of DFU - area of Symphony/area of DFU) x 100.
12 weeks
Cost to closure (both treatment groups; all wounds, and only closed wounds)
Time Frame: 12 weeks
Costs for all wounds per treatment group, and cost of healed wounds only per treatment group. Final values are cost per wound.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aroa Biosurgery Limited

Collaborators

Professional Education and Research Institute

Investigators

  • Study Chair: David Armstrong, DPM, MD PhD, Keck School Of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Estimated)

December 27, 2024

Study Completion (Estimated)

December 27, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AROA 003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Foot

Clinical Trials on Symphony™ plus Off-loading

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe