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Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers

NCT03629236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-04-12

No results posted yet for this study

Summary

A Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL for the Treatment of Chronic VLUs

Conditions

  • Venous Leg Ulcer

Interventions

OTHER

GrafixPL

Debridement, GrafixPL application, dressing application, standard compression therapy

OTHER

Control

Debridement, dressing application, standard compression therapy

Sponsors & Collaborators

  • Osiris Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jaideep Banerjee, PHD · Smith & Nephew, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2021-06-24
Completion
2021-06-24

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 NCT03629236 on ClinicalTrials.gov