Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.
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 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3-layer or equivalent).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Application of Endoform™ Antibacterial
Application of Endoform™ Natural
Application of Symphony™
South Florida Lower Extremity Center
Hollywood, Florida, United States
Advanced Pharma Cr, LLC
Miami, Florida, United States
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks
Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks
Time frame: 12 weeks
Time to heal within 12 weeks
Time to heal of index ulcer defined as 100% re-epithelialization within 12 weeks
Time frame: 12 weeks
Percentage area reduction at 12 weeks
Area reduction percentage of ulcers at 12 weeks
Time frame: 12 weeks
Changes in wound quality of life (per W-QoL)
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). Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
Time frame: 12 weeks
Change in subjects reported pain levels (NPRS)
Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at baseline (Study Visit 1) and after 12 weeks of treatment EOS visit (End of Study Visit).On the numerical pain scale, the number 0 represents "no pain" and the number 10 represents "the worst possible pain".
Time frame: 12 weeks
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