Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
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ClinicalTrials.gov Identifier: NCT06035536 |
Recruitment Status :
Recruiting
First Posted : September 13, 2023
Last Update Posted : December 20, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | August 23, 2023 | ||||||||
First Posted Date ICMJE | September 13, 2023 | ||||||||
Last Update Posted Date | December 20, 2023 | ||||||||
Actual Study Start Date ICMJE | June 8, 2023 | ||||||||
Estimated Primary Completion Date | December 27, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Percentage of index ulcers healed at 12 weeks [ Time Frame: 12 weeks ] Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers | ||||||||
Official Title ICMJE | 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 | ||||||||
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. | ||||||||
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:
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Masking Description: None (Open Label) Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
120 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 27, 2024 | ||||||||
Estimated Primary Completion Date | December 27, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT06035536 | ||||||||
Other Study ID Numbers ICMJE | AROA 003 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Aroa Biosurgery Limited | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Aroa Biosurgery Limited | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Professional Education and Research Institute | ||||||||
Investigators ICMJE |
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PRS Account | Aroa Biosurgery Limited | ||||||||
Verification Date | December 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |