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Intraoperative ICG for Systemic Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03155464
Recruitment Status : Withdrawn (The device that was going to be studied was removed by Duke University shortly after the study was approved.)
First Posted : May 16, 2017
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The primary objective of this study is to evaluate the relative intraoperative improvement in perfusion between arterial reconstruction and sympathectomies with quantitative ICG. A minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to Sympathectomy (group 2), will be recruited for this study. This study will enroll participants in a one to one randomized study design. There is the potential risk of loss of confidentiality. The study involves the intraoperative assessment of perfusion by quantitative ICG. ICG is FDA approved for this usage and will be used according to its labeling. Assessment involves intraoperative quantitative ICG data, questionnaires, and patient and physician assessments. There are no additional physical risks associated with participating in this study over and above that of the planned arterial reconstruction (bypass) and sympathectomies.The information collected will be kept confidential and will comply with the HIPAA.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Procedure: Order of two elements of surgical procedure Drug: Indocyanine Green Phase 4

Detailed Description:

A minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to Sympathectomy (group 2), will be recruited for this study. This study will enroll participants in a 1:1 randomized study design. Participants will serve as their own controls. A consecutive series of patients will be randomized to either Group 1 or 2. Randomization will occur through 40 sealed, opaque sequentially numbered envelopes containing the randomization. Those that qualify and sign consent will be randomized 24hrs prior to surgery. The randomization envelopes will be stored in a locked filing cabinet within the clinical research coordinators office. The subject will know what treatment arm they are in prior to surgery.

Patients will be randomized to Group 1 or 2. If patients are randomized to Group 1, patients will receive sympathectomy prior to bypass during the surgical procedure (see below). If patients are randomized to Group 2, they will received bypass prior to sympathectomy during the surgical procedure (see below). Patients in both groups will be in the study for the next 12 months. Normal clinical practice will not change. Patients in both groups will be examined before surgery. If they provide consent to participate, demographical data, comorbidities, the number and severity of digital ulcerations, and baseline outcome measures for the Michigan Hand Outcome Questionnaire, Disabilities of the Arm, Shoulder and Hand and the Visual Analogue Scale for Pain will be collected.

Patients in both groups will return to the office for routine follow-up at 2 weeks for wound care. The next study visit will occur at 6 weeks. At that time, outcome measures will be again administered and data collected. In accordance with standard clinical practice, the patients will return to the office for examination again at 6 months and 1 year. At these times, the primary clinical outcomes will be collected as well as the patient reported outcomes.

These are normal visits, not outside the scope of routine clinical practice. Intraoperative ICG is also within the scope of routine clinical practice. The dose of ICG and the number of times that it is administered to subjects is the same as in standard of care.

ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. The laser diode array utilized by the SPY System emits a near-infrared wavelength that does not require the use of protective eyewear or other safety equipment. The investigators will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. Of note, No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will enroll participants in a 1:1 randomized study design. Participants will serve as their own controls. A consecutive series of patients will be randomized to either Group 1 or 2. Randomization will occur through 40 sealed, opaque sequentially numbered envelopes containing the randomization. Those that qualify and sign consent will be randomized 24hrs prior to surgery. The randomization envelopes will be stored in a locked filing cabinet within the clinical research coordinators office. The subject will know what treatment arm they are in prior to surgery.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective Study of the Utility of Intraoperative, Quantitative Indocyanine Green Angiography in Microvascular Surgery for Systemic Scerlosis
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : January 23, 2018
Actual Study Completion Date : January 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Group 1

Order of two elements of surgical procedure: patients in group 1 will receive sympathectomy prior to bypass during the surgical procedure.

Indocyanine Green (ICG) will be used in both groups.

Procedure: Order of two elements of surgical procedure
Please see the arm/group descriptions for the order of elements of the surgical procedure in group 1 and group 2.

Drug: Indocyanine Green
Intraoperative ICG has been validated to correlate to postoperative outcomes. ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. We will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.
Other Name: ICG

Group 2

Order of two elements of surgical procedure: Patients in group 2 will receive bypass prior to sympathectomy during the surgical procedure.

Indocyanine Green (ICG) will be used in both groups.

Procedure: Order of two elements of surgical procedure
Please see the arm/group descriptions for the order of elements of the surgical procedure in group 1 and group 2.

Drug: Indocyanine Green
Intraoperative ICG has been validated to correlate to postoperative outcomes. ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. We will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.
Other Name: ICG




Primary Outcome Measures :
  1. Change in perfusion [ Time Frame: Baseline-One Year Follow-up ]
    To compare the relative intraoperative change in perfusion between arterial reconstruction and sympathectomies with quantitative ICG.


Secondary Outcome Measures :
  1. Intraoperative change in hand and digit perfusion [ Time Frame: Baseline-One Year Follow-up ]
    To document the immediate intraoperative quantitative change in hand and digit perfusion in combined arterial reconstruction and sympathectomies in patients with systemic sclerosis using intraoperative quantitative ICG.


Other Outcome Measures:
  1. Comparison of clinical and intraoperative quantitative ICG measurements [ Time Frame: Baseline-One Year Follow-up ]
    Correlation of primary clinical measures with results of intraoperative quantitative ICG at 1 year postoperative

  2. Change in Michigan Hand Outcome Questionnaire [ Time Frame: Baseline-One Year Follow-up ]
    Change in Michigan Hand Outcome Questionnaire

  3. Change in Visual Analogue Scale for Pain (VAS) [ Time Frame: Baseline-One Year Follow-up ]
    Change in Visual Analogue Scale for Pain (VAS); patient reported level of pain which is then measured (distance from 0 in mm)

  4. Change in Disability of the Arm, Shoulder, and Hand Questionnaire (DASH) [ Time Frame: Baseline-One Year Follow-up ]
    Change in DASH score; scale of 0-100. 30 questions in total with optional work and optional sports/activities questions (with 4 questions each)

  5. Complete healing of all ulcers [ Time Frame: 1 Year Follow-up ]
    Complete healing of all ulcers (yes/no)

  6. Number of all ulcers [ Time Frame: 1 Year Follow-up ]
    Number of all ulcers

  7. Need for amputation by the end of one-year follow-up [ Time Frame: 1-year follow-up ]
    Need for amputation by the end of one-year follow-up (yes/no)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • o Patient has signed an IRB approved, study specific Informed Patient Consent Form.

    • Patient is a male or non-pregnant female age 18 - 85 years at time of study enrollment.
    • Patient has a diagnosis of a systemic sclerosis with vascular obstruction of the hand resulting in digital ischemia, ulceration, and/or gangrene and have failed nonoperative treatments.
    • Patient is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria:

  • • Patient is undergoing revision surgery.

    • Patient has a diagnosis of avascular necrosis or inflammatory arthritis.

  • If, during surgery, the arterial reconstruction could not be performed because the vessel was damaged to the point where there was no appropriate site for a bypass anastomosis.

    • Patient is a prisoner
    • Pregnant women confirmed by testing prior to surgery, and nursing mothers
    • Patient has an allergy to iodine confirmed during initial history and on day of surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155464


Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Suhail Mithani, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03155464    
Other Study ID Numbers: Pro00078686
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Duke University:
indocyanine-green
systemic scerlosis
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases