Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabe… (NCT06035536) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study Evaluating Symphonyâ„¢ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
United States143 participantsStarted 2023-06-08
Plain-language summary
The study will evaluate the safety and performance of Symphonyâ„¢ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
Who can participate
Age range18 Years
SexALL
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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 t…