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| Name | Class |
|---|---|
| Osiris Therapeutics | INDUSTRY |
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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.
Screening and Enrollment:
If the subject qualifies for the study, they will participate in the following procedures (weekly visits, +/-4 days):
Visit 0:
Visits 1 - 11:
Visit 12/End of Study (EOS) Visit:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GrafixPL PRIME | Other | Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GrafixPL PRIME | Biological | GrafixPL PRIME |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Closure | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Lavery, DPM MPH | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GrafixPL PRIME | Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GrafixPL PRIME | Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product. GrafixPL PRIME: GrafixPL PRIME |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
|
12 weeks of weekly visits
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GrafixPL PRIME | Open-label case series to evaluate GrafixPL PRIME. All subjects received the product. GrafixPL PRIME: GrafixPL PRIME |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized for foot-related issue | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All adverse events | Infections and infestations | Systematic Assessment | Includes all reinfections of the foot, pneumonia, antibiotics for any reason not including foot infection, and cutaneous abscess on non-study limb. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Lavery, DPM, MPH | UT Southwestern Medical Center at Dallas | 214-645-0544 | Larry.Lavery@UTSouthwestern.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 11, 2019 | Jul 20, 2020 | Prot_ICF_001.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| 12 weeks |
| feet |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
|
| Secondary | Time to Closure | Posted | Mean | Standard Deviation | days | 12 weeks |
|
|
|
| Secondary | 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. | There was no control arm in this study. 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. | Posted | Number | number of adverse events | 12 weeks |
|
|
|
| 0 |
| 40 |
| 5 |
| 40 |
| 23 |
| 40 |
| Non-foot related hospitalization | Infections and infestations | Systematic Assessment |
|
|
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
|