Diabetic Foot Ulcer
Conditions
Brief 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. 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)
Interventions
BIOLOGICALGrafixPL PRIME
GrafixPL PRIME
Sponsors
Osiris Therapeutics
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Unable to provide informed consent * \<18 or \>90 years of age * History of poor compliance with follow-up visits * Gangrene * Untreated Osteomyelitis * Widespread malignancy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Closure of the Index Ulcer | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Closure | 12 weeks | — |
| Total Adverse Events | 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GrafixPL PRIME Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product.
GrafixPL PRIME: GrafixPL PRIME | 40 |
| GrafixPL PRIME Open-label case series to evaluate GrafixPL PRIME. All subjects receive the product.
GrafixPL PRIME: GrafixPL PRIME | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | GrafixPL PRIME |
|---|---|
| Age, Continuous Age of All Participants | 61 years STANDARD_DEVIATION 36 |
| Race/Ethnicity, Customized Race African American | 7 Participants |
| Race/Ethnicity, Customized Race Caucasian | 25 Participants |
| Race/Ethnicity, Customized Race Hispanic | 8 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 23 / 40 |
| serious Total, serious adverse events | 5 / 40 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GrafixPL PRIME | Number of Participants With Complete Closure of the Index Ulcer | 19 Participants |
Secondary
Time to Closure
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GrafixPL PRIME | Time to Closure | 40.0 days | Standard Deviation 20.1 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GrafixPL PRIME | Total Adverse Events | Closed | 6 number of adverse events |
| GrafixPL PRIME | Total Adverse Events | Not closed | 17 number of adverse events |