GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

Foot Ulcer, Diabetic Clinical Trial

Official title:

A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675855
• Other study ID #: Protocol 350
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2016
• Last updated: July 12, 2017
• Start date: January 2016
• Est. completion date: July 2017

Study information

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

Clinical Trial Summary

The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 1 or Type 2 Diabetes

• Chronic ulcer (present for =4 weeks, but not more than 52 weeks)

• Index ulcer located below the malleoli on the plantar or dorsal surface of the foot

• Index ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone or joint capsule

• Adequate circulation to the foot (documented by ABI or TBI)

Exclusion Criteria:

• Gangrene present on affected foot

• Index ulcer is over a Charcot deformity

• Patient is receiving dialysis

• Patient has 2 or more previous amputations

• Patient has HbA1c >12% or random blood sugar >450 mg/dl

• Chronic oral steroid use

• Use of IV corticosteroid, immunosuppressive, or cytotoxic agents

• IV antibiotics

• Another ulcer within 5cm of the Index ulcer

• Cellulitis, evidence of infection, or osteomyelitis

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Other:
• GrafixPRIME®
Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

Procedure:
• Dressing Application
Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

Device:
• Off-loading (walking boot)
Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study

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	Complete closure of index wound		Up to Day 56
Secondary	Time to wound closure		Up to Day 56
Secondary	Proportion of patients that achieve a 50% reduction or greater in wound size		Day 28
Secondary	Number of product applications		Up to Day 56
Secondary	Number of Adverse Events		Up to Day 56
Secondary	Number of patients with worsening of wound by =50% increase in size		Up to Day 56