GrafixPL PRIME Evaluation Case Study
Completed · Phase 4
Conditions studied: Diabetic Foot Ulcer
In brief
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.
Key facts
- Study ID
- NCT03742440
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 40
- Starts
- 2018-11-20
- Expected to finish
- 2020-03-01
- Last updated by the study team
- 2023-07-24
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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