Wound Assessment Using Spectral Imaging EU/UK

NCT05581966 | Completed FDA Device

• 1 other identifier: CT-2022-003
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (1)

Diabetic Foot Ulcer (DFU) Group

Patients with DFUs undergoing 30 day standard wound care (SWC) therapy as part of their standard of care

Diagnostic Test: DV-SSP Imaging

Interventions

DV-SSP Imaging DIAGNOSTIC_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.

Diabetic Foot Ulcer (DFU) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with DFUs undergoing SWC treatment

You may qualify if:

• At least 18 years old.
• Subject has an ulcer, or a 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SpectralMD: lead

Study Sites (1)

Connolly Hospital, Diabetic Day Centre

Abbotstown, Dublin, D15X40D, Ireland

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 17, 2022
• Study Start: March 15, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)