Unacylated Ghrelin to Improve FuncTioning in PAD: The GIFT Trial

• Status: Completed
• Trial end date: 2017-08-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University

Criteria

Inclusion Criteria:

1. PAD patients age 55 and older

Exclusion Criteria:

1. Above or below-knee amputation, critical limb ischemia, and wheelchair confinement.

2. 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.]

3. Major medical illnesses including renal disease requiring dialysis, or cancer requiring treatment in the previous year.

4. 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.

5. Unwilling to attend nine study visits over approximately six months.

6. Surgery including lower extremity revascularization or orthopedic surgery in the previous month or anticipated surgery in the next three months.

7. 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.

8. Blood pressure < 90/50 at baseline.

9. Non-English speaking, a visual impairment that limits ability to read the consent, or a hearing impairment that interferes with study participation.

10. 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.