DiabetesNCT05415683
Wound Assessment Using Spectral Imaging US
An observational study of Diabetes and Diabetic Foot, run by SpectralMD at 11 sites in United States.
Trial summary
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer
- What is being tested?
- DV-SSP Imaging
- How many people
- 400 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Jun 2022to 30 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with DFUs undergoing SWC treatment
Who may be able to join
- At least 18 years old.
- Subject has an ulcer, or slow healing wound that is full thickness for at least 4 weeks, below the malleolus, in the presence of Diabetes.
- The target ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study.
- The target ulcer is planned to undergo standard wound care (SWC) therapy (See 8.6 Standard Wound Care (SWC) Therapy).
- Subject understands and is willing to participate in the clinical study and can comply with required visits.
Who cannot join
- Target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes.
- Target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- Eligible DFU has associated untreated acute osteomyelitis or active infection
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), or cytotoxic chemotherapy.
- Subjects on any investigational drug(s) or device(s) within 30 days preceding initial study visit.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Cutting Edge Research LLC
Circleville, Ohio, 43920
Surgery of Foot and Ankle
Encino, California, 91316
Gentle Foot Care
Grove City, Ohio, 43123
Gentle Foot Care
Hilliard, Ohio, 43026
Northwell Hospital
Lake Success, New York, 11042
New Hope Podiatry Group
Los Angeles, California, 90063
University of Tennessee Health Science Center, Wound Care Center @ Regional One
Memphis, Tennessee, 38103
Foot and Ankle Specialist of Ohio
Mentor, Ohio, 44060
West Houston Foot and Ankle
Missouri City, Texas, 77459
Worthington Foot and Ankle
Worthington, Ohio, 43085
Lower Extremity Institute of Research & Therapy (LEIRT)
Youngstown, Ohio, 44512
About this study
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Pre- and post-debridement images will be obtained (if debridement performed per SOC), as well as reviewing medical history and physical assessments.
Additional Study Visits (SVs) will be performed when patient returns to the clinic for Routine Clinic Visit for up to 12 weeks or wound closure. During these visits DeepView imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer
- Being tested
- DV-SSP Imaging
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DV-SSP ImagingDiagnostic test
DeepView utilizes imaging data from DFUs to aid in health care providers' assessment of wound healing potential. It is intended to be used as an aid to health care providers in the management of DFU wounds and not as a standalone prediction device.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Foot Ulcer (DFU) Group | Patients with DFUs undergoing 30 day standard wound care (SWC) therapy as part of their standard of care Receives: Diagnostic Test: DV-SSP Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection
The purpose of this study is to build a database for development and validation of a machine learning (ML) algorithm for diabetic foot ulcer (DFU) healing assessment using images obtained with the Spectral MD DeepView device.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start22 Jun 2022
- Primary completion28 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpectralMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415683
- Sponsor's protocol ID
- CT-2022-01-CIP
- Status last verified
- Nov 2024
- First submitted
- 8 Jun 2022
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Assessment Using Spectral Imaging US
- ClinicalTrials.gov ID
- NCT05415683
- Acronym / sponsor ID
- CT-2022-01-CIP
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- SpectralMDIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 13 Jun 2022 (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.
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Pre- and post-debridement images will be obtained (if debridement performed per SOC), as well as reviewing medical history and physical assessments.
Additional Study Visits (SVs) will be performed when patient returns to the clinic for Routine Clinic Visit for up to 12 weeks or wound closure. During these visits DeepView imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Foot Ulcer (DFU) Group | – | Diagnostic Test: DV-SSP ImagingPatients with DFUs undergoing 30 day standard wound care (SWC) therapy as part of their standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with DFUs undergoing SWC treatment
Key inclusion criteria (5 listed)
- At least 18 years old.
- Subject has an ulcer, or slow healing wound that is full thickness for at least 4 weeks, below the malleolus, in the presence of Diabetes.
- The target ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study.
- The target ulcer is planned to undergo standard wound care (SWC) therapy (See 8.6 Standard Wound Care (SWC) Therapy).
- Subject understands and is willing to participate in the clinical study and can comply with required visits.
Key exclusion criteria (5 listed)
- Target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes.
- Target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- Eligible DFU has associated untreated acute osteomyelitis or active infection
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), or cytotoxic chemotherapy.
- Subjects on any investigational drug(s) or device(s) within 30 days preceding initial study visit.
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 |
|---|---|---|
| DV-SSP ImagingDeepView utilizes imaging data from DFUs to aid in health care providers' assessment of wound healing potential. It is intended to be used as an aid to health care providers in the management of DFU wounds and not as a standalone prediction device. | Diagnostic test | Diabetic Foot Ulcer (DFU) Group |
Primary outcome
Data Collection
Time frame: 12 weeks
The purpose of this study is to build a database for development and validation of a machine learning (ML) algorithm for diabetic foot ulcer (DFU) healing assessment using images obtained with the Spectral MD DeepView device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetic Foot, run by SpectralMD at 11 sites 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Data Collection (time frame: 12 weeks). 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 8 Nov 2024.