NCT05417425

Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers

A Clinical Study Using Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Omeza, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.

Detailed description

The study will include three phases: screening phase, treatment phase and healing confirmation. All measurements in the trial are captured by Tissue Analytics.The two week screening phase is to confirm the chronicity of the diabetic foot ulcer (DFU) and the eligibility of subjects. Subjects will be treated with standard of care (SOC) which includes cleaning of the wound, debridement when needed, dressing, and offloading. If the ulcer decreases by 30% in area measurement after 2 weeks of SOC, then the subject does not qualify for the treatment phase. The treatment phase begins with assessment to confirm continued eligibility and if met, subjects are treated weekly with the OCM™ therapy plus continued offloading. At the conclusion of 4 weekly treatments, the ulcer will be assessed by PI for response and evaluation of percent area reduction. Continued therapy through treatment visit 12 is at the PI's discretion where percent area reduction is assessed and recorded. OCM™ results will be compared to a Control Group of subjects identified and matched retrospectively from the same site, who received the same advanced treatments that the OCM™ treated cohort had received prior to the trial.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant	The three omeza products were designed to be used in combination for the treatment of chronic wounds

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2022-06-14
• Last updated: 2024-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study