Clinical trial NCT03629236: Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers
Official title: 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 Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Osiris Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. 18 years or older, as of the date of screening
2. An Index Ulcer that is chronic (defined as present for \> 4 weeks, but not present for more than 52 weeks at Screening Visit 1)
3. Index Ulcer is located on the leg, below the knee and above the malleoli (ulcer may be inclusive of the malleoli)
4. 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.
5. The Index Ulcer has had compression therapy for \> 2 weeks at Screening Visit 1
6. The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
7. Patient has adequate circulation to the foot, as documented up to 14 days prior to Screening Visit 1
8. Confirmed diagnosis of venous insufficiency, as documented up to 30 days prior to enrollment

Exclusion Criteria:

1. Index Ulcer is of non-venous pathophysiology
2. Gangrene is present on any part of the affected limb
3. Patient is unable to tolerate standard compression therapy
4. 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
5. Patient is receiving intravenous (IV) corticosteroids, immunosuppressive or cytotoxic agents at any time during the screening period
6. Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
7. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
8. 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
9. Evidence of osteomyelitis at the time of Screening and Baseline Visits
10. Patient has active malignancy other than non-melanoma skin cancer
11. Patient's Index Ulcer has decreased by ≥ 30% between Screening Visit 1 and the Baseline Visit during the screening period
12. Patient has untreated alcohol or substance abuse at the time of Screening Visit 1
13. Pregnant women and women who are breastfeeding
14. Patient is currently enrolled in or has participated in another investigational device, drug, or biological trial within 30 days prior to Screening Visit 1
15. 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
16. Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
17. Patients who have already been randomized in Protocol 360 at any center may not be considered for screening or for re-entry into the trial at any center, even after the End of Treatment Study Visit
18. Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol

Primary outcomes:
measure: Complete closure of the index ulcer
timeFrame: Up to 84 days after the Baseline Visit
Secondary outcomes:
measure: Time to initial ulcer closure
timeFrame: Up to 84 days after the Baseline Visit
measure: Measurement of percent area reduction in ulcers that do not achieve closure
timeFrame: 84 days after the Baseline Visit
measure: Proportion of patients with ulcer reoccurrence in Follow-Up Phase
timeFrame: Up to 6 months after initial ulcer closure
measure: Proportion of patients in the Crossover Extension Treatment Phase who achieve complete ulcer closure
timeFrame: Up to 91 days after initial Treatment Phase
measure: Time to initial ulcer among patients in the Crossover Extension Treatment Phase
timeFrame: Up to 91 days after initial Treatment Phase
Other outcomes:
measure: Number and type of AEs and SAEs
timeFrame: Through study completion, approximately 38 weeks
measure: Number and type of ulcer related complications
timeFrame: Through study completion, approximately 38 weeks
measure: CWIS Questionnaire
timeFrame: Through study completion, approximately 38 weeks
measure: WPAI Questionnaire
timeFrame: Through study completion, approximately 38 weeks
Locations:
city: Doral
country: United States
facility: Integral Clinical Trial Solutions
state: Florida
city: Weymouth
country: United States
facility: SSH
state: Massachusetts
Study officials:
affiliation: Smith & Nephew, Inc.
name: Jaideep Banerjee, PHD
role: STUDY_CHAIR
References: