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Completed

NCT Number: NCT02675855

GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arizona City, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GrafixPRIME®

Other

Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

Dressing Application

Procedure

Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

Off-loading (walking boot)

Device

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

Primary outcomes

  1. Complete closure of index wound

    Time frame: Up to Day 56

Secondary outcomes

  1. Time to wound closure

    Time frame: Up to Day 56

  2. Proportion of patients that achieve a 50% reduction or greater in wound size

    Time frame: Day 28

  3. Number of product applications

    Time frame: Up to Day 56

  4. Number of Adverse Events

    Time frame: Up to Day 56

  5. Number of patients with worsening of wound by ≥50% increase in size

    Time frame: Up to Day 56

Sponsors and collaborators

Lead sponsor

Osiris Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2016
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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