Diabetic Foot UlcerNCT04232631
Non-Invasive Testing to Evaluate Wound Healing in Diabetes
An observational study of Diabetic Foot Ulcer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- SnapshotNIR, Kent Imaging
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Investgator's patients, normal healthy volunteers
Who may be able to join
- Patient of the investigators
- Diagnosis of diabetes mellitus
- One or more moderate to severe diabetic foot ulcers/infections
- 18-89 years of age
- Over 18
- Have a foot
Who cannot join
- Non-diabetic
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
- Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
- Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
- Patients with a history of poor compliance
Show all 9Show fewer
- Normal Healthy volunteers
- Foot wounds
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
About this study
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.
Read the detailed description
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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- SnapshotNIR, Kent Imaging
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SnapshotNIR, Kent ImagingDevice
Vascular imaging device
| Study group | Role | What they receive |
|---|---|---|
| patients with diabetic foot ulcers | * Patient of the investigators
* Diagnosis of diabetes mellitus
* One or more moderate to severe diabetic foot ulcers/infections
* 18-89 years of age Receives: Device: SnapshotNIR, Kent Imaging | |
| Normal healthy volunteers | over 18 years of age have a foot Receives: Device: SnapshotNIR, Kent Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start28 Apr 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Crisologo, DPM, University of Texas Southwestern Medical Center
- Investigators
- Andrew P Crisologo, DPM, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232631
- Sponsor's protocol ID
- STU-2018-0386
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Testing to Evaluate Wound Healing in Diabetes
- ClinicalTrials.gov ID
- NCT04232631
- Acronym / sponsor ID
- STU-2018-0386
- Conditions
- Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- SuspendedReason 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.
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with diabetic foot ulcers | – | Device: SnapshotNIR, Kent Imaging* Patient of the investigators * Diagnosis of diabetes mellitus * One or more moderate to severe diabetic foot ulcers/infections * 18-89 years of age |
| Normal healthy volunteers | – | Device: SnapshotNIR, Kent Imagingover 18 years of age have a foot |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Investgator's patients, normal healthy volunteers
Key inclusion criteria (6 listed)
- Patient of the investigators
- Diagnosis of diabetes mellitus
- One or more moderate to severe diabetic foot ulcers/infections
- 18-89 years of age
- Over 18
Key exclusion criteria (9 listed)
- Non-diabetic
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
- Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
- Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SnapshotNIR, Kent ImagingVascular imaging device | Device | Normal healthy volunteers, patients with diabetic foot ulcers |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew P Crisologo, DPM principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.