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

Venous Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629236
• Other study ID #: Osiris Protocol 360
• Status: Completed
• Phase: N/A
• Start date: June 27, 2018
• Est. completion date: June 24, 2021

Study information

• Verified date: March 2022
• Source: Osiris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Other known NCT identifiers

• NCT03543007

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 24, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Other:
• GrafixPL
Debridement, GrafixPL application, dressing application, standard compression therapy
• Control
Debridement, dressing application, standard compression therapy

Locations

Country	Name	City	State
United States	Integral Clinical Trial Solutions	Doral	Florida
United States	SSH	Weymouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Osiris Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number and type of AEs and SAEs		Through study completion, approximately 38 weeks
Other	Number and type of ulcer related complications		Through study completion, approximately 38 weeks
Other	CWIS Questionnaire		Through study completion, approximately 38 weeks
Other	WPAI Questionnaire		Through study completion, approximately 38 weeks
Primary	Complete closure of the index ulcer		Up to 84 days after the Baseline Visit
Secondary	Time to initial ulcer closure		Up to 84 days after the Baseline Visit
Secondary	Measurement of percent area reduction in ulcers that do not achieve closure		84 days after the Baseline Visit
Secondary	Proportion of patients with ulcer reoccurrence in Follow-Up Phase		Up to 6 months after initial ulcer closure
Secondary	Proportion of patients in the Crossover Extension Treatment Phase who achieve complete ulcer closure		Up to 91 days after initial Treatment Phase
Secondary	Time to initial ulcer among patients in the Crossover Extension Treatment Phase		Up to 91 days after initial Treatment Phase