Chronic Venous Leg Ulcers
Conditions
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.
Interventions
OTHERTruSkin
OTHERWound Cover
Sponsors
Osiris Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients that achieve a 50% or greater reduction in wound size by 8 weeks | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients that achieve a 50% or greater reduction in wound size by 4 weeks | 4 weeks |
| Time to initial wound closure | Up to 84 days |
| Proportion of patients that achieve complete closure of the index wound by 12 weeks | 12 weeks |
| Number of AEs | Up to 84 days |
| Number of patients with worsening of index wound defined by ≥ 50% increase in wound size | Up to 84 days |
| Number of product applications | Up to 84 days |
Countries
United States
Outcome results
None listed