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

NCT03629236 | Completed

• 1 other identifier: Osiris Protocol 360
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Complete closure of the index ulcer

  Up to 84 days after the Baseline Visit

Secondary Outcomes (5)

• Time to initial ulcer closure

  Up to 84 days after the Baseline Visit

• Measurement of percent area reduction in ulcers that do not achieve closure

  84 days after the Baseline Visit

• Proportion of patients with ulcer reoccurrence in Follow-Up Phase

  Up to 6 months after initial ulcer closure

• Proportion of patients in the Crossover Extension Treatment Phase who achieve complete ulcer closure

  Up to 91 days after initial Treatment Phase

• Time to initial ulcer among patients in the Crossover Extension Treatment Phase

  Up to 91 days after initial Treatment Phase

Other Outcomes (4)

• Number and type of AEs and SAEs

  Through study completion, approximately 38 weeks

• Number and type of ulcer related complications

  Through study completion, approximately 38 weeks

• CWIS Questionnaire

  Through study completion, approximately 38 weeks

Study Arms (2)

GrafixPL

EXPERIMENTAL

Other: GrafixPL

Control

ACTIVE COMPARATOR

Other: Control

Interventions

GrafixPL OTHER

Debridement, GrafixPL application, dressing application, standard compression therapy

Also known as: Tissue Allograft

GrafixPL

Control OTHER

Debridement, dressing application, standard compression therapy

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older, as of the date of screening
• An Index Ulcer that is chronic (defined as present for \> 4 weeks, but not present for more than 52 weeks at Screening Visit 1)
• Index Ulcer is located on the leg, below the knee and above the malleoli (ulcer may be inclusive of the malleoli)
• The Index Ulcer is between 1 cm2 and 25 cm2, inclusive, at the Screening and Baseline Visits. The longest dimension of the index ulcer cannot exceed 10 cm at the Baseline Visit.
• The Index Ulcer has had compression therapy for \> 2 weeks at Screening Visit 1
• The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
• Patient has adequate circulation to the foot, as documented up to 14 days prior to Screening Visit 1
• Confirmed diagnosis of venous insufficiency, as documented up to 30 days prior to enrollment

You may not qualify if:

• Index Ulcer is of non-venous pathophysiology
• Gangrene is present on any part of the affected limb
• Patient is unable to tolerate standard compression therapy
• Glycated hemoglobin A1c (HbA1c) level of \> 14% in any patient with type 1 or type 2 diabetes mellitus, as documented up to 14 days prior to Screening Visit 1
• Patient is receiving intravenous (IV) corticosteroids, immunosuppressive or cytotoxic agents at any time during the screening period
• Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
• Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
• Current evidence of infection at the Index Ulcer, including cellulitis and/or pus drainage from the ulcer site at the time of Screening and Baseline Visits
• Evidence of osteomyelitis at the time of Screening and Baseline Visits
• Patient has active malignancy other than non-melanoma skin cancer
• Patient's Index Ulcer has decreased by ≥ 30% between Screening Visit 1 and the Baseline Visit during the screening period
• Patient has untreated alcohol or substance abuse at the time of Screening Visit 1
• Pregnant women and women who are breastfeeding
• Patient is currently enrolled in or has participated in another investigational device, drug, or biological trial within 30 days prior to Screening Visit 1
• Patient has had within 14 days of Screening Visit 1, or is currently undergoing, or is planning for ulcer treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies

Sponsors & Collaborators

• Osiris Therapeutics: lead

Study Sites (2)

Integral Clinical Trial Solutions

Doral, Florida, 33126, United States

Location

SSH

Weymouth, Massachusetts, 02189, United States

Location

Related Publications (1)

• Dhillon Y, Levine L, Tovmassian G, Reyzelman A, Perez-Clavijo F, Wodie F, Cazzell S, Grossman A, Robinson L, Sigal F, Kirsner RS, Vartivarian M, Saunders M, Banerjee J. A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers. Health Sci Rep. 2025 May 4;8(5):e70819. doi: 10.1002/hsr2.70819. eCollection 2025 May.

  PMID: 40330756 DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jaideep Banerjee, PHD

  Smith & Nephew, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: August 14, 2018
• Study Start: June 27, 2018
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-03

Locations

US (2)