Indocyanine Green Tissue Perfusion Monitoring

NCT02978560 | Completed DMC

• 1 other identifier: HP-00071920
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Regional Blood Flow; Wound Heal

Outcome Measures

Primary Outcomes (1)

• Indocyanine Green Tissue Perfusion Monitoring

  Flow measurements on normal skin and sites of diabetic neuropathic wounds

  2 years

Study Arms (2)

control

The source population for this cohort will be 30 healthy individuals with no know cardiovascular disease or wound healing defects. Subjects will be recruited by word-of-mouth, who receive no remuneration and who will be selected for the study on the basis of inclusion and exclusion criteria. They will undergo fluorescence-mediated photoplethysmography once.

Diagnostic Test: fluorescence-mediated photoplethysmography

Wound Group

The source population will be 30 patients who present to wound care clinic with Diabetic Foot Ulcers. Candidate subjects will have had a standard wound evaluation and medical history taken as a matter of their standard of care. On the basis of the evaluation, the physician-investigators will determine if the patient meets the eligibility criteria. If so, the study will be explained to the patient at that time, and Informed Consent will be obtained. 30 healthy subjects will also be included, recruited by word-of-mouth, who receive no remuneration and who will be selected for the study on the basis of the following inclusion and exclusion criteria. They will undergo fluorescence-mediated photoplethysmography once at the onset of their wound care.

Diagnostic Test: fluorescence-mediated photoplethysmography

Interventions

fluorescence-mediated photoplethysmography DIAGNOSTIC_TEST

Indocyanine green dye (ICG) will be injected intravenously as a sterile solution at a dose of 0.5 mg/kg, and then imaging of skin will be done with a fluorescence camera. The ICG-angiogram sequence will consist of 1.5 x 2.0-cm field-of-view ICG fluorescence images acquired at the rate of approximately 30/sec during a period of about 15 seconds. Following acquisition of the initial transit angiogram sequence, several additional 15-second-long image sequences will be acquired during the next half-hour, but without any additional injections.

Wound Group; control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Baltimore Medical & Surgical Associates PA: collaborator

Study Sites (1)

Baltimore Medical & Surgical Associates PA

Towson, Maryland, 21204, United States

Location

Related Publications (1)

• Flower RW, Mirza Z, Thom SR. Absolute quantification (ml blood/sec * mm2 tissue) of normal vs. diabetic foot skin microvascular blood perfusion: Feasibility of FM-PPG measurements under clinical conditions. Microvasc Res. 2019 May;123:58-61. doi: 10.1016/j.mvr.2018.12.004. Epub 2018 Dec 24.

  PMID: 30590061 RESULT

Study Officials

• Stephen R Thom, MD, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 1, 2016
• Study Start: March 5, 2018
• Primary Completion: June 28, 2018
• Study Completion: July 1, 2018
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)