Foot Ulcer, DiabeticPhase 4NCT02675855
GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
A Phase 4 study testing GrafixPRIME®, Dressing Application and Off-loading (walking boot) in people with Foot Ulcer, Diabetic, run by Osiris Therapeutics at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- GrafixPRIME®, Dressing Application and Off-loading (walking boot)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2016to Jul 2017
- 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
- 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)
Who cannot join
- 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
Show all 10Show fewer
- Use of IV corticosteroid, immunosuppressive, or cytotoxic agents
- IV antibiotics
- Another ulcer within 5cm of the Index ulcer
- Cellulitis, evidence of infection, or osteomyelitis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Arizona City, Arizona
Study site
California City, California
Study site
New Mexico, New Mexico
About this study
Official title: A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator 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.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- GrafixPRIME®, Dressing Application, Off-loading (walking boot)
- Keywords
- Grafix
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrafixPRIME®Other
Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.
Dressing ApplicationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| GrafixPRIME® | Experimental | GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices Receives: Other: GrafixPRIME®; Device: Off-loading (walking boot) |
| Active Comparator | Active comparator | Wound cover, Dressing Application Patients will be fitted with off-loading devices Receives: Procedure: Dressing Application; Device: Off-loading (walking boot) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete closure of index wound
Measured: Up to Day 56
Secondary outcomes (5)
Time to wound closure
Measured: Up to Day 56
Proportion of patients that achieve a 50% reduction or greater in wound size
Measured: Day 28
Number of product applications
Measured: Up to Day 56
Number of Adverse Events
Measured: Up to Day 56
Number of patients with worsening of wound by ≥50% increase in size
Measured: Up to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osiris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharron McCulloch, Study director, Director, Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675855
- Sponsor's protocol ID
- Protocol 350
- Status last verified
- Jul 2017
- First submitted
- 1 Feb 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02675855
- Acronym / sponsor ID
- Protocol 350
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- Grafix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Osiris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 5 Feb 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GrafixPRIME® | Experimental | Other: GrafixPRIME®, Device: Off-loading (walking boot)GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices |
| Active Comparator | Active comparator | Procedure: Dressing Application, Device: Off-loading (walking boot)Wound cover, Dressing Application Patients will be fitted with off-loading devices |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| GrafixPRIME®Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing. | Other | GrafixPRIME® |
| Dressing ApplicationWound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing. | Procedure or surgery | Active Comparator |
| 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 | Device | Active Comparator, GrafixPRIME® |
Primary outcome
Complete closure of index wound
Time frame: Up to Day 56
5 secondary outcomes
Time to wound closure
Time frame: Up to Day 56
Proportion of patients that achieve a 50% reduction or greater in wound size
Time frame: Day 28
Number of product applications
Time frame: Up to Day 56
Number of Adverse Events
Time frame: Up to Day 56
Number of patients with worsening of wound by ≥50% increase in size
Time frame: Up to Day 56
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 17 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Sharron McCulloch study director
Director, Clinical Affairs
3 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 GrafixPRIME®, Dressing Application and Off-loading (walking boot) in people with Foot Ulcer, Diabetic, run by Osiris Therapeutics at 3 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 5 inclusion and 10 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 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Complete closure of index wound (time frame: Up to Day 56). 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 17 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.