Effect of NIRS-assisted Assessment on Chronic Lower Extremity and Other Chronic Non-healing Ulcers

NCT06702852 | Terminated FDA Device

• 1 other identifier: MG-NIRS-03
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 4

Brief Summary

Investigation of the predictive value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic non-healing Ulcers

Conditions

Ulcers

Keywords

tissue oxygenation; Near infrared spectroscopy; lower extremity ulcers; ulcers; SnapshotNIR; NIRS; imaging; oxyhemoglobin; deoxyhemoglobin; hemoglobin; oxygen saturation; wound healing

Outcome Measures

Primary Outcomes (1)

• Patient health outcome

  To evaluate the impact of the addition of NIRS to the SOP on patient health outcome by comparing between the control and interventional groups

  From enrollment to closeout or 12 weeks from enrollment whichever is earlier

Secondary Outcomes (1)

• Health Economic Impact

  From enrollment to closeout or 12 weeks from enrollment whichever is earlier

Study Arms (2)

Control

NO INTERVENTION

The control group will receive the standard of care per the facility Standard Operating Procedures (SOP)

Intervention

EXPERIMENTAL

The intervention group will receive the standard of care per the facility Standard Operating Procedures (SOP) with the addition of NIRS imaging utilizing the SnapshotNIR

Device: NIRS imaging in addition to SOC

Interventions

NIRS imaging in addition to SOC DEVICE

The intervention group will receive the standard of care per the facility Standard Operating Procedures (SOP) with the addition of NIRS imaging utilizing the SnapshotNIR

Intervention

Eligibility Criteria

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

You may qualify if:

• Current patients or patients admitted to Christus Wound Care and Hyperbaric Medicine Departments between July 1, 2024, and December 31, 2024, for the treatment of lower extremity ulcers and other chronic non-healing ulcers.
• Lower extremity ulcers and chronic non-healing ulcers will be included in the study regardless of the wound/ulcer etiology. Patients may become eligible for the study at any point during their course of treatment.

You may not qualify if:

• Patients who are being treated at multiple research sites simultaneously.

Sponsors & Collaborators

• Kent Imaging Inc: lead
• WoundCentrics LLC: collaborator

Study Sites (4)

Christus Santa Rosa Wound Care and Hyperbaric Center

New Braunfels, Texas, 78130, United States

Location

Christus Santa Rosa Wound Care and Hyperbaric Center

San Antonio, Texas, 78229, United States

Location

Christus Santa Rosa Wound Care and Hyperbaric Center

San Antonio, Texas, 78251, United States

Location

Christus Santa Rosa Wound Care and Hyperbaric Center

San Marcos, Texas, 78666, United States

Location

Related Publications (4)

• Serena TE, Yaakov R, Serena L, Mayhugh T, Harrell K. Comparing near infrared spectroscopy and transcutaneous oxygen measurement in hard-to-heal wounds: a pilot study. J Wound Care. 2020 Jun 1;29(Sup6):S4-S9. doi: 10.12968/jowc.2020.29.Sup6.S4.

  PMID: 32530756 BACKGROUND

• Geskin G, Mulock MD, Tomko NL, Dasta A, Gopalakrishnan S. Effects of Lower Limb Revascularization on the Microcirculation of the Foot: A Retrospective Cohort Study. Diagnostics (Basel). 2022 May 26;12(6):1320. doi: 10.3390/diagnostics12061320.

  PMID: 35741130 BACKGROUND

• Farber A. Chronic Limb-Threatening Ischemia. N Engl J Med. 2018 Jul 12;379(2):171-180. doi: 10.1056/NEJMcp1709326. No abstract available.

  PMID: 29996085 BACKGROUND

• NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016 Apr 9;387(10027):1513-1530. doi: 10.1016/S0140-6736(16)00618-8. Epub 2016 Apr 6.

  PMID: 27061677 BACKGROUND

MeSH Terms

Conditions

Ulcer; Leg Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marcus L Gitterle, MD

  CHRISTUS Santa Rosa Hospital Wound Care and Hyperbaric Center - San Antonio, Westover Hills, San Marcos and New Braunfels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: November 25, 2024
• Study Start: July 22, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 25, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)