Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

PHASE4RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

July 11, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2027

Conditions
Diabetic Foot UlcerDFUDiabetic Foot Ulcer (DFU)Foot Ulcer Due to Type 1 Diabetes MellitusFoot Ulcer Due to Type 2 Diabetes MellitusUlcerUlcer Foot
Interventions
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.

Trial Locations (1)

15146

RECRUITING

Serena Group- Monroeville, Monroeville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Serena Group

OTHER

lead

Sequence LifeScience, Inc.

INDUSTRY