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Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care

NCT06564831 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-11-20

No results posted yet for this study

Summary

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Foot
  • Foot Ulcer
  • Ulcer Foot
  • DFU

Interventions

OTHER

SLAM + SOC

Weekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

SOC

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Sponsors & Collaborators

  • SerenaGroup, Inc.

    collaborator NETWORK

  • Applied Biologics, LLC

    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
2024-09-20
Primary Completion
2025-02-28
Completion
2025-08-31

Countries

  • United States

Study Locations

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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 NCT06564831 on ClinicalTrials.gov