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 4×4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3-layer or equivalent).
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By 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.