NCT06572839

Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Capsicure, LLC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled study evaluates the adjuvant use of Amnio-Maxx in patients with diabetic foot ulcers

Detailed description

This is a multicenter randomized open-label clinical study in patients with Wagner grade 1 and 2 DFUs. Diabetic patients presenting with chronic nonhealing ulcers will be screened for eligibility. At least 50% of the eligible population will be drawn from patients ≥ 65 years of age. All patients will complete a 2-week run-in period prior to treatment allocation to Amnio-Maxx and standard of care (SOC) or SOC alone. Patients will be seen at weekly intervals (± 3 days) for the 12 weeks treatment period. If additional dressing changes are required between the scheduled visits, the occurrence of these visits will be recorded. Primary efficacy endpoints include percentage change in ulcer size at 12 weeks along with the proportion of participants achieving complete wound closure. Additionally, pain and safety will be assessed as secondary endpoints.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	Amnio-Maxx	Amnio-Maxx Dual Layer Amnion Patch is processed using aseptic techniques, treated with a saline solution and dehydrated.

Timeline

• Start date: 2024-10-25
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2024-08-27
• Last updated: 2025-04-30

Locations

12 sites across 1 country: United States