TruSkin®: Study for the Treatment of Chronic Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

Official title:

A Multicenter, Randomized, Single-Blind Study Comparing the Clinical Outcomes of TruSkin® and an Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02936115
• Other study ID #: Osiris Protocol 351
• Status: Terminated
• Phase: Phase 4
• First received: September 20, 2016
• Last updated: April 4, 2017
• Start date: July 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Osiris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Between 18 years and 80 years of age inclusive, as of the date of screening

2. Confirmed diagnosis of Type 1 or Type 2 Diabetes

3. An Index Ulcer that is chronic (defined as present for > 4 weeks, but not present for more than 52 weeks at the Screening Visit)

4. Index Ulcer is located below the malleolus

5. The Index Ulcer is a Diabetic Foot Ulcer (DFU) greater than 3 cm2, inclusive, at the Screening Visit

6. The longest length and longest width measurements for the Index Ulcer are no less than 1 cm each at the Screening Visit

7. The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule

8. Wound is free of necrotic debris

9. Patient has adequate circulation to the foot as documented by ABI or TBI

Exclusion Criteria:

1. Index Ulcer is of non-diabetic pathophysiology

2. Gangrene is present on any part of the affected foot

3. Index Ulcer is over a Charcot deformity

4. Patient is currently receiving dialysis or planning to go on dialysis

5. Patient has a glycated hemoglobin A1c (HbA1c) level of >12%

6. Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening

7. Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening

8. Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening

9. Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration

10. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)

11. Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site

12. Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening

13. Patient has active malignancy other than non-melanoma skin cancer

14. Patient's Index Ulcer has decreased by = 20% during 1-week screening period

15. Patient's random blood sugar is > 450 mg/dl at screening

16. Patient is unable to properly off-load the index wound as a part of standard of care

17. Patient has untreated alcohol or substance abuse at the time of screening

18. Pregnant women and women who are breastfeeding

19. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening

20. 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

21. Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study

22. Patients who have already been randomized in Protocol 351 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

23. Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Other:
• TruSkin®

• Wound Cover

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Osiris Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients that achieve a 50% or greater reduction in wound size by 8 weeks		8 weeks
Secondary	Proportion of patients that achieve complete closure of the index wound by 12 weeks		12 weeks
Secondary	Proportion of Patients that achieve a 50% or greater reduction in wound size by 4 weeks		4 weeks
Secondary	Time to initial wound closure		Up to 84 days
Secondary	Number of product applications		Up to 84 days
Secondary	Number of AEs		Up to 84 days
Secondary	Number of patients with worsening of index wound defined by = 50% increase in wound size		Up to 84 days