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

NCT07159282 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-11

No results posted yet for this study

Summary

A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.

Conditions

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

Interventions

OTHER

XWRAP

Application of XWRAP + standard of care for up to 12 weeks.

Sponsors & Collaborators

  • SerenaGroup, Inc.

    collaborator NETWORK

  • Applied Biologics, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2027-08-31
Completion
2027-08-31

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 NCT07159282 on ClinicalTrials.gov