NCT06035523

Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™

A Single Arm Pilot Study Evaluating Wound Closure With a Unique Staged Application of Endoform™ and Symphony™ in the Treatment of Non-Healing Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Aroa Biosurgery Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Wound Healing
• Diabetic Foot
• Chronic Foot Ulcer
• Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Endoform™ Antibacterial	Application of Endoform™ Antibacterial
DEVICE	Endoform™ Natural	Application of Endoform™ Natural
DEVICE	Symphony™	Application of Symphony™

Timeline

• Start date: 2021-12-29
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2023-09-13
• Last updated: 2026-01-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study