Diabetic Foot Ulcer Clinical Trial
Official title:
GrafixPL PRIME Evaluation Case Study
Verified date | July 2023 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 1, 2020 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center at Dallas | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | Osiris Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 12 weeks | |
Secondary | Time to Closure | 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. | 12 weeks |
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