Wound Assessment Using Spectral Imaging EU/UK

NCT ID: NCT05581966

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2024-06-28

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetic Foot Ulcer (DFU) Group

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

DV-SSP Imaging

Intervention Type: 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.

Interventions

DV-SSP Imaging

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SpectralMD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Connolly Hospital, Diabetic Day Centre

Abbotstown, Dublin, Ireland

Countries

Ireland

Other Identifiers

CT-2022-003

Identifier Type: -

Identifier Source: org_study_id