NCT07086443

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Placental Derived Allografts and Standard of Care in the Treatment of Nonhealing Diabetic Foot Ulcers Using Matched Controls

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Sequence LifeScience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.

Detailed description

This study is a prospective modified platform multicenter randomized controlled clinical trial. The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.

Conditions

• Diabetic Foot Ulcer
• DFU
• Diabetic Foot Ulcer (DFU)
• Foot Ulcer Due to Type 1 Diabetes Mellitus
• Foot Ulcer Due to Type 2 Diabetes Mellitus
• Ulcer
• Ulcer Foot

Interventions

Type	Name	Description
OTHER	Activate™ Matrix	Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	AmnioDefend™ FT Matrix	Participants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Palisade™ DM Matrix	Participants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Enclose™ TL Matrix	Participants will receive weekly applications of Enclose™ TL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Sentry™ SL Matrix	Participants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Shelter™ DM Matrix + SOC	Participants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Timeline

• Start date: 2025-07-11
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States