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Diabetic Foot UlcersPhase 4DFUNCT01596920

Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers

A Phase 4 study testing Tissue in people with Diabetic Foot Ulcers, run by Osiris Therapeutics at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Foot Ulcers
What is being tested?
Tissue
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
15 sitesUnited States
Study dates
Apr 2012to Mar 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between 18 years and 80 years of age inclusive, as of the date of screening
  • Confirmed diagnosis of Type I or Type II Diabetes
  • An Index Ulcer defined as chronic (presence of wound for > 4 weeks) but not present for more than 52 weeks at the Screening Visit
  • Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot
  • The Index Ulcer is between 1cm2 and 15 cm2 at the Screening Visit
  • The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
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  • Wound is free of necrotic debris
  • Patient has adequate circulation to the foot as documented by either:
  • Ankle Brachial Index (ABI) > 0.70 and < 1.30, or
  • In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30, a Toe Brachial Index (TBI) ≥ 0.50
  • In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30 and TBI cannot be performed (e.g., toe is absent, wounds are present, or site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g., duplex imaging, normal pulse volume recording [PVR] testing).

Who cannot join

  • Index Ulcer is of non-diabetic pathophysiology
  • Gangrene is present on any part of the affected foot
  • Index Ulcer is over an active Charcot deformity
  • The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
  • Patient is currently receiving dialysis
  • Patient has a glycated hemoglobin A1c (HbA1c) level of > 12%
Show all 20Show fewer
  • Chronic oral steroid use > 7.5 mg daily
  • Requiring intravenous (IV) antibiotics to treat the index wound infection
  • Patient has an ulcer within 15cm of the Index Ulcer identified for study consideration
  • Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
  • Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
  • Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site
  • Patient has active malignancy other than non-melanoma skin cancer
  • Patient's Index Ulcer has decreased by ≥ 30% during 1-week screening period as determined by criteria provided by the Wound Core Lab
  • Patient's random blood sugar is > 450 mg/dl at screening
  • Patient has untreated alcohol or substance abuse at the time of screening
  • Pregnant women
  • Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening
  • Patient has allergy to primary or secondary dressing materials used in this trial
  • Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Blair Orthopedics Associates, Inc

    Altoona, Pennsylvania, 16602

  • UNC at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75235

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • ILD Laser and Research Center

    Encinitas, California, 92024

  • Aiyan Diabetes Center

    Evans, Georgia, 30809

  • Clinical Trials of Arizona, Inc.

    Glendale, Arizona, 85306

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • River City Clinical Research

    Jacksonville, Florida, 32207

  • Institute for Advanced Wound Care at Baptist Medical

    Montgomery, Alabama, 36111

  • Clincal Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Ocean County Foot and Ankle Surgical Associates

    Toms River, New Jersey, 08753

  • Omega Medical Research

    Warwick, Rhode Island, 02886

Other trials in United States

About this study

Official title: A Multicenter, Adaptive Design, Randomized, Single-Blind Study With an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Grafix® for the Treatment of Chronic Diabetic Foot Ulcers

The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator.

Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue Based Product (HCT/P) under Title 21 CFR Part 1271.

Read the detailed description

The treatment indication is for chronic, diabetic foot ulcers (DFUs) between 1cm2 and 15cm2 located below the malleoli on the plantar or dorsal surface of the foot. Patients must have confirmed Type I or Type II Diabetes.

Patients will receive treatment every week for 12 weeks duration in the Single-Blind Treatment phase of the trial.

Patients who receive Grafix® or control will be evaluated for primary efficacy up to 84 days, and for safety and wound re-occurrence for 84 days after wound closure. Patients in the control group whose wounds are not closed at the end of treatment may be offered Grafix® in an Open-Label Treatment phase. The Open-Label Treatment phase can last up to an additional 84 days.

Being tested
Tissue, Control
Keywords
Chronic DFUs, Diabetic Foot Ulcers
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TissueOther

    Allograft Tissue Cellular Repair Matrix

  • ControlOther

    Non-adherent Dressing

Study groups in NCT01596920
Study groupRoleWhat they receive
Grafix®Active comparatorNot described
Receives: Other: Tissue
Control (non-adherent dressing)Placebo comparatorNot described
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator, anytime up to the Day 84 Visit

    Measured: Up to 84 days

Secondary outcomes (5)

  1. Time to initial wound closure

    Measured: Up to 84 days after the Single-Blind Treatment Visits

  2. number of patients with >50% reduction in wound size by Day 28

    Measured: Up to 84 days after the Single-Blind Treatment Visits

  3. number of applications of Grafix® versus control

    Measured: Up to 84 days after the Single-Blind Treatment Visits

  4. number of re-occurrences of index wound post-healing

    Measured: Up to 84 days after the Single-Blind Treatment Visits

  5. percent of wounds achieving complete closure

    Measured: Up to 84 days after the Single-Blind Treatment Visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2013
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01596920
Sponsor's protocol ID
Osiris 302
Acronym
DFU
Status last verified
Apr 2014
First submitted
14 Mar 2012
Last updated
9 Apr 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tissue in people with Diabetic Foot Ulcers, run by Osiris Therapeutics at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator, anytime up to the Day 84 Visit (time frame: Up to 84 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01596920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.

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