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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with diabetic foot ulcers |
|
| |
| Normal healthy volunteers | over 18 years of age have a foot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SnapshotNIR, Kent Imaging | Device | Vascular imaging device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the effectiveness of SnapshotNIR device to measure perfusion to predict wound healing, flap survival and amputation level healing. The device will report the oxygen saturation, oxyhemoglobin and deoxyhemoglobin levels in superficial tissue. | To evaluate the effectiveness of the Kent instrument to measure perfusion to predict wound healing, flap survival and amputation level healing. | Three years |
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Investigator patients
Inclusion Criteria:
Exclusion Criteria:
Normal Healthy volunteers
Inclusion Criteria:
Exclusion Criteria:
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Investgator's patients, normal healthy volunteers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Debby Noble | Contact | 2146488686 | Debby.Noble@UTSouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrew P Crisologo, DPM | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center at Dallas | Recruiting | Dallas | Texas | 75390 | United States |
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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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| 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 |