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Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone

NCT06764953 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-09

No results posted yet for this study

Summary

The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with SOC versus FIBRACOL™ with SOC. Other research purposes include the following:

* Rate of wound closure
* Change in ulcer size over 12 weeks
* Any adverse events or reactions (side effects)
* Change in pain levels
* Occurrence of infection

Conditions

  • Venous Leg Ulcers

Interventions

OTHER

E-GRAFT ™

E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue-Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act.

DEVICE

FIBRACOL™

510K FDA cleared Collagen alginate dressing

Sponsors & Collaborators

  • Skye Biologics Holdings, LLC

    lead INDUSTRY

Principal Investigators

  • Charles M Zelen, DPM FACFAS · Professional Education and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-28
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

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 NCT06764953 on ClinicalTrials.gov