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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02675855
Other study ID # Protocol 350
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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