MedTrace Logo

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

NCT07086443 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-05-19

No results posted yet for this study

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.

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

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.

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.

Sponsors & Collaborators

  • Serena Group

    collaborator OTHER

  • Sequence LifeScience, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07086443 on ClinicalTrials.gov