Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT06035536|
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : November 22, 2023
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Diabetic Foot Ulcer Foot Ulcer Chronic Foot Ulcer||Device: Symphony™ plus Off-loading Device: Wound Dressing comprising of calcium alginate Fibracol||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||None (Open Label)|
|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|
|Actual Study Start Date :||June 8, 2023|
|Estimated Primary Completion Date :||December 27, 2024|
|Estimated Study Completion Date :||December 27, 2024|
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.
- Percentage of index ulcers healed at 12 weeks [ Time Frame: 12 weeks ]Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks
- Time to heal within 12 weeks [ Time Frame: 12 weeks ]Time to heal of index ulcer defined as 100% re-epithelialization within 12 weeks
- Percentage area reduction at 12 weeks [ Time Frame: 12 weeks ]Area reduction percentage of ulcer at 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).
- 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".
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035536
|Contact: Shelby Cayloremail@example.com|
|Contact: Frances Parkerfirstname.lastname@example.org|
|United States, California|
|LA Foot and Ankle||Recruiting|
|Los Angeles, California, United States, 90010|
|Contact: Maira Jackson 213-365-0793 email@example.com|
|Principal Investigator: Felix Sigal, DPM|
|Clemente Clinical Research Inc.||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Stanley Mathis, DPM 949-412-8445|
|Bay Area Foot Care||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Maria Peralta 800-363-1069 ext 104 firstname.lastname@example.org|
|Principal Investigator: Alex Reyzelman, DPM|
|United States, Florida|
|Doctor's Research Network||Recruiting|
|Miami, Florida, United States, 33143|
|Contact: Patria Division 305-665-3017 email@example.com|
|Principal Investigator: Jason Hanft|
|Barry University Clinical Research||Recruiting|
|Tamarac, Florida, United States, 33321|
|Contact: Maria Swartz 305-836-7550 MSwartz@barry.edu|
|Principal Investigator: Robert Snyder, DPM|
|United States, North Carolina|
|Foot and Ankle Specialists of the Mid-Atlantic||Recruiting|
|Gastonia, North Carolina, United States, 28054|
|Contact: Dana Jones 704-861-0425 firstname.lastname@example.org|
|Principal Investigator: Ryan Meredith, DPM|
|United States, Ohio|
|Lower Extremity Institute for Research and Therapy||Recruiting|
|Boardman, Ohio, United States, 44512|
|Contact: Jessica DiDomenico 234-719-7588 email@example.com|
|Principal Investigator: Lawrence A DiDomenico, DPM|
|United States, Pennsylvania|
|Martin Foot and Ankle||Recruiting|
|York, Pennsylvania, United States, 17402|
|Contact: Maria Kasper, DPM 717-757-3537 firstname.lastname@example.org|
|Contact: Renee Green 717-757-3537 email@example.com|
|Principal Investigator: Maria A Kasper, DPM|
|Study Chair:||David Armstrong, DPM, MD PhD||Keck School of Medicine|