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Non-Invasive Testing to Evaluate Wound Healing in Diabetes

StatusSuspended
PhaseNot specified
Started2021-04-28
View on ClinicalTrials.gov ↗
Why the trial stopped
Temporarily closed to enrollment as the company that provided the hyperspectral imaging camera to previous PI had new PI return the devices. Since study is unfunded, currently investigating rental cost of the device.

Amendment history

2026-09-24
Recruitment suspended: Temporarily closed to enrollment as the company that provided the hyperspectral imaging camera to previous PI had...
2025-08-08
Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v12
Primary completion date2025-09→2026-09
Completion date2025-09→2026-09
2024-08-06
Study Status, Study Description, Arms and Interventions, Outcome Measures v11
InterventionsSnapshot NIH, Kent Imaging (Device)→SnapshotNIR, Kent Imaging (Device)
Primary endpoints1 entry, revised
Evaluating the effectiveness of 1SnapshotNIR 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.
2024-08-02
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v10
Enrollment target200→700
Study arms1→2
InterventionsHyperview, HyperMed Imaging (Device), IntraOx Vioptix (Device), Snapshot NIH, Kent Imaging (Device)→Snapshot NIH, Kent Imaging (Device)
Eligibility criteria+141 characters
Investigator patients Inclusion Criteria: Patient of the investigators Diagnosis o [...] d study materials Patients with a history of poor compliance Normal Healthy volunteers Inclusion Criteria: Over 18 Have a foot Exclusion Criteria: Foot wounds Non-English speaking
Primary endpoints1 entry, revised
Evaluating the effectiveness of 31 devicesdevice to measure perfusion to predict wound healing, flap survival and amputation level healing.
Study description+232 characters
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 havingrequiring avascular intervention or lower extremity ulceration (includes lower extremity wound [...] , their lower extremity will be imaged. They will be imaged beforepreop, during,intraop (if feasible) and on post-op day 1 + or - 7 days if they require surgery and for each surgery related to the [...] so be imaged once a month in follow up for up to a total of 126 months or healing of the wound, whicheverdetermined comesby fi [...] [...]
2023-07-20
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 1 site
Show 8 earlier versions
2023-04-26
Study Status v8
Re-verified, no change to tracked fields
2022-04-19
Study Status v7
Primary completion date2022-09→2025-09
Completion date2022-09→2025-09
2021-04-28
Study Status v6
Start date2021-04-14→2021-04-28
2021-04-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-04-01→confirmed 2021-04-14
Study sitesdetails revised at 1 of 1 site
2021-03-18
Study Status v4
Start date2021-03-01→2021-04-01
2021-02-15
Study Status v3
Start date2021-01-01→2021-03-01
2020-11-16
Study Status v2
Start date2020-11-02→2021-01-01
2020-10-20
Study Status v1
Start date2020-07→2020-11-02
2020-01-14
Original filing
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.
Trial Details
NCT Number NCT04232631
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Diabetic Foot Ulcer
Enrollment 700 participants
Start Date 2021-04-28
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-23