Diabetic Foot UlcerPhase 4NCT03742440
GrafixPL PRIME Evaluation Case Study
A Phase 4 study testing GrafixPL PRIME in people with Diabetic Foot Ulcer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL PRIME. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- GrafixPL PRIME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2018to 1 Mar 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- 18-90 years of age
- Chronic foot ulceration below the ankle - persistent for 30 days or longer
- Ankle Brachial Index (ABI) >0.5 (Bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery)
Who cannot join
- Unable to provide informed consent
- <18 or >90 years of age
- History of poor compliance with follow-up visits
- Gangrene
- Untreated Osteomyelitis
- Widespread malignancy
Show all 9Show fewer
- Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines
- Currently Pregnant or planning pregnancy during the course of intended participation in the study
- Is nursing or actively lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
About this study
The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data on other potential confounding factors that could affect healing such as medications, tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated. The objective of this study is to understand the use of this product to evaluate wound healing in 40 patients.
Read the detailed description
Screening and Enrollment:
- Review and sign the Informed Consent and HIPAA Authorization
- Review the inclusion and exclusion criteria
If the subject qualifies for the study, they will participate in the following procedures (weekly visits, +/-4 days):
Visit 0:
- Demographics (such as age, gender, race or ethnicity)
- Medical/Surgical and Social History, Current Antibiotics.
- Laboratory Results
- Vascular - ABI
- Neurological evaluation - Monofilament and VPT
- Vitals - Sitting blood pressure and Pulse rate, Height/Weight, and BMI
- Wound debridement
- eKare - Wound imaging measurement
- Application of GrafixPL PRIME
- Current Antibiotics
- Offloading
- Adverse Events
- Source documentation
Visits 1 - 11:
- Wound debridement
- eKare - Wound imaging measurement
- Application of GrafixPL PRIME
- Current Antibiotics
- Offloading
- Adverse Events
- Source documentation
Visit 12/End of Study (EOS) Visit:
- Wound debridement
- eKare - Wound imaging measurement
- Current Antibiotics
- Offloading
- Adverse Events
- Source documentation (End of Study will occur on the date the subject is healed)
- Conditions
- Diabetic Foot Ulcer
- Being tested
- GrafixPL PRIME
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrafixPL PRIMEBiological
GrafixPL PRIME
| Study group | Role | What they receive |
|---|---|---|
| GrafixPL PRIME | Other | Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. Receives: Biological: GrafixPL PRIME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Closure of the Index Ulcer
Complete closure of the index ulcer, defined as 100% re-epithelialization as determined by the Investigator by week 12 or the End of Treatment Visit.
Measured: 12 weeks
Secondary outcomes (2)
Time to Closure
Measured: 12 weeks
Total Adverse Events
There was no control arm in this study - everyone enrolled received treatment. Analysis of these data was separated into two groups - "closed wounds" and "not closed wounds." Wounds that closed achieved full epithelialization within the 12 week study time frame. Wounds that did not close did not achieve full epithelialization by the end of study visit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start20 Nov 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Osiris Therapeutics
- Responsible party
- Principal investigator, Larry Lavery, University of Texas Southwestern Medical Center
- Investigators
- Lawrence Lavery, DPM MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742440
- Sponsor's protocol ID
- 022018-035
- Status last verified
- Jul 2023
- First submitted
- 9 Nov 2018
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GrafixPL PRIME Evaluation Case Study
- ClinicalTrials.gov ID
- NCT03742440
- Acronym / sponsor ID
- 022018-035
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Osiris Therapeutics
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Posted 30 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data on other potential confounding factors that could affect healing such as medications, tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated. The objective of this study is to understand the use of this product to evaluate wound healing in 40 patients.
Detailed description
Screening and Enrollment:
- Review and sign the Informed Consent and HIPAA Authorization
- Review the inclusion and exclusion criteria
If the subject qualifies for the study, they will participate in the following procedures (weekly visits, +/-4 days):
Visit 0:
- Demographics (such as age, gender, race or ethnicity)
- Medical/Surgical and Social History, Current Antibiotics.
- Laboratory Results
- Vascular - ABI
- Neurological evaluation - Monofilament and VPT
- Vitals - Sitting blood pressure and Pulse rate, Height/Weight, and BMI
- Wound debridement
- eKare - Wound imaging measurement
- Application of GrafixPL PRIME
- Current Antibiotics
- Offloading
- Adverse Events
- Source documentation
Visits 1 - 11:
- Wound debridement
- eKare - Wound imaging measurement
- Application of GrafixPL PRIME
- Current Antibiotics
- Offloading
- Adverse Events
- Source documentation
Visit 12/End of Study (EOS) Visit:
- Wound debridement
- eKare - Wound imaging measurement
- Current Antibiotics
- Offloading
- Adverse Events
- Source documentation (End of Study will occur on the date the subject is healed)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GrafixPL PRIME | Other | Biological: GrafixPL PRIMEOpen-label case series to evaluate GrafixPL PRIME. All subjects receive the product. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide informed consent
- 18-90 years of age
- Chronic foot ulceration below the ankle - persistent for 30 days or longer
- Ankle Brachial Index (ABI) >0.5 (Bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery)
Key exclusion criteria (9 listed)
- Unable to provide informed consent
- <18 or >90 years of age
- History of poor compliance with follow-up visits
- Gangrene
- Untreated Osteomyelitis
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 |
|---|---|---|
| GrafixPL PRIMEGrafixPL PRIME | Biological | GrafixPL PRIME |
Primary outcome
Number of Participants With Complete Closure of the Index Ulcer
Time frame: 12 weeks
Complete closure of the index ulcer, defined as 100% re-epithelialization as determined by the Investigator by week 12 or the End of Treatment Visit.
2 secondary outcomes
Time to Closure
Time frame: 12 weeks
Total Adverse Events
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lawrence Lavery, DPM MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GrafixPL PRIME in people with Diabetic Foot Ulcer, run by University of Texas Southwestern Medical Center at 1 site 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 4 inclusion and 9 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 30 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Closure of the Index Ulcer (time frame: 12 weeks). 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 24 Jul 2023.