Status:
COMPLETED
Unacylated Ghrelin to Improve FuncTioning in PAD: The GIFT Trial
Lead Sponsor:
Northwestern University
Conditions:
Peripheral Artery Disease
PAD
Eligibility:
All Genders
55+ years
Phase:
PHASE1
PHASE2
Brief Summary
The GIFT pilot study will investigate the optimal subcutaneous dose and safety of subcutaneously administered unacylated ghrelin in older people with peripheral artery disease (PAD).
Detailed Description
The pilot GIFT Trial will obtain preliminary evidence to identify the optimal dose of subcutaneously administered unacylated ghrelin in people with PAD. The results of this pilot study may be used to ...
Eligibility Criteria
Inclusion
- 1\. PAD patients age 55 and older
Exclusion
- Above or below-knee amputation, critical limb ischemia, and wheelchair confinement.
- Cardiovascular event during the previous three months. \[Note: Participants who have undergone coronary revascularization for a cardiac event during the previous three months may still qualify.\]
- Major medical illnesses including renal disease requiring dialysis, or cancer requiring treatment in the previous year.
- Participation in another clinical trial or completion of a clinical trial in the previous month, unless they were in the control group of the previous trial.
- Unwilling to attend nine study visits over approximately six months.
- Surgery including lower extremity revascularization or orthopedic surgery in the previous month or anticipated surgery in the next three months.
- Greater than 15 mmHg difference in blood pressure in both arm pressure measurements during the ankle brachial index (ABI), diagnosis of Raynaud's phenomenon, or unable to have the blood pressure checked in both arms.
- Blood pressure \< 90/50 at baseline.
- Non-English speaking, a visual impairment that limits ability to read the consent, or a hearing impairment that interferes with study participation.
- In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
Key Trial Info
Start Date :
June 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03358355
Start Date
June 7 2016
End Date
August 30 2017
Last Update
March 12 2020
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611