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

NCT02936115 | Terminated Phase 4

• 1 other identifier: Osiris Protocol 351
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients that achieve a 50% or greater reduction in wound size by 8 weeks

  8 weeks

Secondary Outcomes (6)

• Proportion of patients that achieve complete closure of the index wound by 12 weeks

  12 weeks

• 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

• Number of product applications

  Up to 84 days

• Number of AEs

  Up to 84 days

Study Arms (2)

TruSkin®

EXPERIMENTAL

Cryopreserved skin allograft

Other: TruSkin®

Wound Cover

ACTIVE COMPARATOR

Active Comparator for Diabetic Foot Ulcers

Other: Wound Cover

Interventions

TruSkin® OTHER

TruSkin®

Wound Cover OTHER

Wound Cover

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 years and 80 years of age inclusive, as of the date of screening
• Confirmed diagnosis of Type 1 or Type 2 Diabetes
• 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 below the malleolus
• The Index Ulcer is a Diabetic Foot Ulcer (DFU) greater than 3 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 ABI or TBI

You may not qualify if:

• Index Ulcer is of non-diabetic pathophysiology
• Gangrene is present on any part of the affected foot
• Index Ulcer is over a Charcot deformity
• 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

Sponsors & Collaborators

• Osiris Therapeutics: lead

Study Sites (5)

Unknown Facility

Florida City, Florida, United States

Location

Unknown Facility

Illinois City, Illinois, United States

Location

Unknown Facility

Michigan, Michigan, United States

Location

Unknown Facility

Texas City, Texas, United States

Location

Unknown Facility

Virginia City, Virginia, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: October 18, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)