Clinical trial NCT02936128: TruSkin®: Study for Treatment of Chronic Venous Leg Ulcers
Official title: A Multicenter, Randomized, Single-Blind Study Comparing the Clinical Outcomes of TruSkin® and an Active Comparator for the Treatment of Chronic Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Venous Leg Ulcers
Lead sponsor: Osiris Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic venous leg ulcers.


Eligibility criteria: Inclusion Criteria:

1. Between 18 years and 80 years of age inclusive, 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 the Screening Visit)
3. Index Ulcer is located on the leg, below the knee
4. The Index Ulcer is a Venous Leg Ulcer (VLU) greater than 10 cm2, inclusive, at the Screening Visit
5. The longest length and longest width measurements for the Index Ulcer are no less than 1 cm each at the Screening Visit
6. The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
7. Wound is free of necrotic debris
8. Patient has adequate circulation to the foot as documented by Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)
9. Confirmed diagnosis of venous insufficiency with duplex ultrasonography to demonstrate reflux of ≥ 0.5 seconds in the superficial lower extremity venous system.

Exclusion Criteria:

1. Index Ulcer is of non-venous pathophysiology
2. Gangrene is present on any part of the affected limb
3. Patient is currently receiving dialysis or planning to go on dialysis
4. Patient has a glycated hemoglobin A1c (HbA1c) level of \>12%
5. Chronic oral steroid use \>7.5 mg daily for longer than 3 months at the time of screening
6. Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
7. Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
8. Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
9. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
10. Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site
11. Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
12. Patient has active malignancy other than non-melanoma skin cancer
13. Patient's Index Ulcer has decreased by ≥ 20% during 1-week screening period
14. Patient's random blood sugar is \> 450 mg/dl at screening
15. Patient is unable to receive compression therapy as a part of standard of care
16. Patient has untreated alcohol or substance abuse at the time of screening
17. Pregnant women and women who are breastfeeding
18. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
19. Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies
20. Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
21. Patients who have already been randomized in Protocol 352 at any center may not be considered for screening or for re-entry into the trial at any center, even after the End of Study Visit
22. Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol

Primary outcomes:
measure: Proportion of patients that achieve a 50% or greater reduction in wound size by 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Proportion of patients that achieve complete closure of the index wound by 12 weeks
timeFrame: 12 weeks
measure: Proportion of patients that achieve a 50% or greater reduction in wound size by 4 weeks
timeFrame: 4 weeks
measure: Time to initial wound closure
timeFrame: Up to 84 days
measure: Number of product applications
timeFrame: Up to 84 days
measure: Number of AEs
timeFrame: Up to 84 days
measure: Number of patients with worsening of index wound defined by ≥ 50% increase in wound size
timeFrame: Up to 84 days
Other outcomes:
Locations:
city: California
country: United States
state: California
city: Florida
country: United States
state: Florida
city: Massachusetts
country: United States
state: Massachusetts
city: Michigan
country: United States
state: Michigan
city: North Carolina
country: United States
state: North Carolina
city: Pennsylvania
country: United States
state: Pennsylvania
city: Virginia
country: United States
state: Virginia
Study officials:
References: