TruSkin®: Study for Treatment of Chronic Venous Leg Ulcers

Stopped early · Phase 4

Conditions studied: Chronic Venous Leg Ulcers

In brief

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

Key facts

Study ID

NCT02936128

Run by

Osiris Therapeutics

People needed

7

Starts

2016-07-01

Expected to finish

2017-04-01

Last updated by the study team

2017-04-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Index Ulcer is of non-venous pathophysiology
• Gangrene is present on any part of the affected limb
• Patient is currently receiving dialysis or planning to go on dialysis
• Patient has a glycated hemoglobin A1c (HbA1c) level of >12%
• Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening
• Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
• Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
• 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 cellulitis, or other evidence of infection including fever or pus drainage from the wound site
• Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
• Patient has active malignancy other than non-melanoma skin cancer
• Patient's Index Ulcer has decreased by ≥ 20% during 1-week screening period
• Patient's random blood sugar is > 450 mg/dl at screening
• Patient is unable to receive compression therapy as a part of standard of care
• Patient has untreated alcohol or substance abuse at the time of screening
• Pregnant women and women who are breastfeeding
• Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
• 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
• Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
• 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
• Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol

Where it is running

• Study site — California City, California, United States
• Study site — Florida City, Florida, United States
• Study site — Massachusetts, Massachusetts, United States
• Study site — Michigan, Michigan, United States
• Study site — North Carolina, North Carolina, United States
• Study site — Pennsylvania, Pennsylvania, United States
• Study site — Virginia City, Virginia, United States

Full record on ClinicalTrials.gov

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