UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Location status: Recruiting
NCT Number: NCT04232631
Normal group: We will collect normative data from healthy individuals to include baseline data, screening, and images. Up to 500 people will be enrolled and can include normal healthy volunteers, staff and students/trainees. Data will be collected one time with no follow up.
Patient group: We will prospectively collect data using one instrument (camera) (SnapshotNIR, Kent Imaging, Calgary, Alberta, Canada). We will collect non-contact imaging data before surgeries, during surgeries (if feasible), and during follow-up clinic visits. We will collect vascular data, demographic medical history, wound characteristics and measurements, frequency of debridement, off-loading, and clinic visits from existing medical records. We will collect lab data such as cultures glycosylated hemoglobin, hemoglobin and hematocrit, ESR, CRP and eGFR obtained per standard of care.
Imaging with this device is research-only.
Interested in participating?
Request Info18 year–89 year
All sexes
Observational
Dallas, Texas, 75390, United States
Location status: Recruiting
This is a prospective, observational study. All medical and surgical care provided to the patient group will be standard of care.
Patient group: Once a patient is identified as requiring vascular intervention or lower extremity ulceration (includes lower extremity wound of any cause, a surgical incision, a flap or graft) and consent to participation, their lower extremity will be imaged. They will be imaged preop, intraop (if feasible) and on post-op day 1 + or - 7 days if they require surgery and for each surgery related to the ulceration. They will also be imaged once a month in follow up for up to a total of 6 months or healing of the wound, determined by study physician.
Normal group: The normal group will have one-time imaging and data collection.
The Kent instrument does not touch the patient and is being evaluated to measure perfusion to predict wound healing, flap survival and amputation level healing. They are research only and not standard of care, and are not being used to determine care in the patient group.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Investigator patients
Inclusion criteria
Exclusion criteria
Normal Healthy volunteers
Inclusion criteria
Exclusion criteria
Vascular imaging device
Time frame: Three years
To evaluate the effectiveness of the Kent instrument to measure perfusion to predict wound healing, flap survival and amputation level healing.
Contact information is provided by the study sponsor or research team.
University of Texas Southwestern Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07465640
Cardiovascular Diseases, Diabetes Complications
Kuala Lumpur, Malaysia
View Trial DetailsNCT05950659
Cardiovascular Diseases, Diabetes
Baltimore, Maryland, United States
View Trial DetailsNCT07291817
Cardiovascular Diseases, Diabetes Complications
Singapore
View Trial DetailsNCT07300163
Cardiovascular Diseases, Diabetes Complications
Vilnius, Lithuania
View Trial Details