Complex Diabetic Foot WoundsPhase 4NCT02260609
GrafixCORE®: Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE® for Complex Diabetic Foot Wounds
A Phase 4 study testing Grafix® in people with Complex Diabetic Foot Wounds, run by Osiris Therapeutics at 4 sites in United States.
Trial summary
A multicenter, open-label, single-arm study to evaluate the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Complex Diabetic Foot Wounds
- What is being tested?
- Grafix®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2014to Oct 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 years and 85 years of age inclusive, as of the date of screening
- Confirmed diagnosis of Type I or Type II Diabetes
- Index wound graded in the Texas Classification System as Grade II-III, Stage A or C (without active infection)
- Wound is located on the foot below the malleoli
- Wound accommodates up to three (3) 5 cm x 5 cm pieces of GrafixCORE® that completely cover the wound
- Patient's wound extends through the dermis and into subcutaneous tissue with evidence of exposed muscle, tendon, bone, and/or joint capsule
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- Patient has adequate circulation to the foot as documented by either:
- Ankle Brachial Index (ABI) ≥ 0.5 and ≤ 1.2, or
- In patients with non-compressible ankle vessels, a Toe BP ≥ 40 mmHg or TcPO2 > 30 mmHg, or
- Skin perfusion pressure > 30 mmHg
Who cannot join
- Index Wound is of non-diabetic pathophysiology
- Gangrene is present on any part of the affected foot
- Index Wound is over a Charcot deformity
- The longest dimension of the Index Wound exceeds 15 cm at the Baseline Visit
- Patient has a glycated hemoglobin A1 (HbA1c) level of >14%
- Requiring intravenous (IV) antibiotics to treat the index wound infection at enrollment
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- Patient has a wound 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 random blood sugar is >450 mg/dl at screening
- Patient has untreated alcohol or substance abuse at the time of screening, or is deemed to be non-adherent to the protocol by the Investigator
- Pregnant women
- Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
- Patient has allergy to primary or secondary dressing materials used in this trial
- Patient has had within the last 14 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies
- In the opinion of the Investigator, the patient is unsuitable for participation in the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Miami VA
Miami, Florida, 33125
Carl T. Hayden Medical Research Foundation
Phoenix, Arizona, 85012
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
South Shore Hospital
Weymouth, Massachusetts, 02190
About this study
Official title: A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety and Efficacy of GrafixCORE® for the Treatment of Complex Diabetic Foot Wounds With Exposed Tendon and/or Bone
A multicenter, open-label, single-arm study to evaluate the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone.
- Conditions
- Complex Diabetic Foot Wounds
- Being tested
- Grafix®
- Keywords
- Complex Wound, Diabetic Foot Ulcer, DFU, GrafixCORE, Exposed tendon, Exposed bone, Allograft tissue
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grafix®Other
Also called Tissue, Allograft Tissue
The treatment indication is for complex diabetic foot wounds with exposed tendon and/or bone that can accommodate up to three 5cm x 5cm pieces of Grafix®.
Patients will be treated for up to 16 weeks.
Patients will be evaluated at screening and then weekly throughout the study or until wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label | Other | Grafix®: Cryopreserved Placental Membrane Receives: Other: Grafix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
100% granulation of wound as determined by the investigator
Measured: Up to 16 weeks after the Initial Treatment Visit
Secondary outcomes (4)
Time to 100% granulation
Measured: Up to 16 weeks after the Initial Treatment Visit
Number of applications of Grafix®
Measured: Up to 16 weeks after the Initial Treatment Visit
Measurement of percent wound area reduction as determined by the investigator
Measured: Up to 16 weeks after the Initial Treatment Visit
Closure of wound defined by 100% re-epithelialization
Measured: Up to 16 weeks after the Initial Treatment Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Diabetic Foot WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osiris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260609
- Sponsor's protocol ID
- Osiris Protocol 310
- Status last verified
- Feb 2016
- First submitted
- 6 Oct 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety and Efficacy of GrafixCORE® for the Treatment of Complex Diabetic Foot Wounds With Exposed Tendon and/or Bone
- ClinicalTrials.gov ID
- NCT02260609
- Acronym / sponsor ID
- Osiris Protocol 310
- Conditions
- Complex Diabetic Foot Wounds
- Keywords
- Complex Wound, Diabetic Foot Ulcer, DFU, GrafixCORE, Exposed tendon, Exposed bone, Allograft tissue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Osiris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, open-label, single-arm study to evaluate the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label | Other | Other: Grafix®Grafix®: Cryopreserved Placental Membrane |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Between 18 years and 85 years of age inclusive, as of the date of screening
- Confirmed diagnosis of Type I or Type II Diabetes
- Index wound graded in the Texas Classification System as Grade II-III, Stage A or C (without active infection)
- Wound is located on the foot below the malleoli
- Wound accommodates up to three (3) 5 cm x 5 cm pieces of GrafixCORE® that completely cover the wound
Key exclusion criteria (18 listed)
- Index Wound is of non-diabetic pathophysiology
- Gangrene is present on any part of the affected foot
- Index Wound is over a Charcot deformity
- The longest dimension of the Index Wound exceeds 15 cm at the Baseline Visit
- Patient has a glycated hemoglobin A1 (HbA1c) level of >14%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grafix®Also: Tissue, Allograft TissueThe treatment indication is for complex diabetic foot wounds with exposed tendon and/or bone that can accommodate up to three 5cm x 5cm pieces of Grafix®. Patients will be treated for up to 16 weeks. Patients will be evaluated at screening and then weekly throughout the study or until wound closure. | Other | Open-Label |
Primary outcome
100% granulation of wound as determined by the investigator
Time frame: Up to 16 weeks after the Initial Treatment Visit
4 secondary outcomes
Time to 100% granulation
Time frame: Up to 16 weeks after the Initial Treatment Visit
Number of applications of Grafix®
Time frame: Up to 16 weeks after the Initial Treatment Visit
Measurement of percent wound area reduction as determined by the investigator
Time frame: Up to 16 weeks after the Initial Treatment Visit
Closure of wound defined by 100% re-epithelialization
Time frame: Up to 16 weeks after the Initial Treatment Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
Related trials for Complex Diabetic Foot Wounds
Recruiting
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Grafix® in people with Complex Diabetic Foot Wounds, run by Osiris Therapeutics at 4 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 10 inclusion and 18 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
100% granulation of wound as determined by the investigator (time frame: Up to 16 weeks after the Initial Treatment Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2016.