Indocyanine Green Tissue Perfusion Monitoring

Completed

Conditions studied: Regional Blood Flow, Wound Heal

In brief

The aim of this project is to demonstrate that fluorescence-mediated photoplethysmography (FM-PPG) is capable of routinely acquiring the tissue perfusion data sufficient to detect and monitor skin tissue perfusion anomalies.

Key facts

Study ID

NCT02978560

Run by

University of Maryland, Baltimore

People needed

15

Starts

2018-03-05

Expected to finish

2018-07-01

Last updated by the study team

2024-11-27

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects, of any ethnic background, who are at least 21 years of age and have normal healthy skin (30 normal subjects) or patients with diabetic foot ulcer lesions (30 patients).
• All subjects must be willing and be able to comply with the protocol, and to provide informed consent.

You may not qualify if…

• Patient currently participating in any other drug or device investigational study.
• Patient with significant liver or kidney disease.
• Patient with known adverse reaction to indocyanine green or iodine.
• Patient is pregnant or nursing.
• Patient with peripheral vascular disease and an ankle-brachial index blood flow of 0.6 or less

Where it is running

• Baltimore Medical & Surgical Associates PA — Towson, Maryland, United States

Full record on ClinicalTrials.gov

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