Summary:
ICON Early Phase Services is conducting a research study for adults age 21 and over who are either diabetic and with or without mild renal disease, or, adults who have mild to moderate renal disease. This study is being done to test the administration of fluids/drugs using a needle inserted into the bone marrow.
Vital signs, ECGs, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
- 1 screening visit
- 2 consecutive overnight stays at the clinic
- 4 follow-up phone calls
- 1 outpatient visit
Qualified participants may be compensated up to $2,500 for time and travel.
To determine if you fully qualify, it will be necessary to obtain blood samples after a 4 hour fast. You may need to provide medical records to participate in this study. For more information, see below.
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a controlled type 1 or type 2 diabetic with or without renal disease OR I am an adult with mild to moderate renal disease
- I am ≥ 21 years old
- (If) I am a smoker, I am able to refrain from smoking during my stay at the clinic
- I have not received an investigational study drug or device in a clinical trial within 30 days prior to admit for this study
- If Female, I am not pregnant or breastfeeding
- I do not have a history of alcohol or drug abuse
- I have not had an intraosseous (within the bone) insertion in the past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in the target bone
- I have poor vascular access (i.e., requiring at least 2 or more attempts to achieve peripheral vascular access or blood draws)
- I have not had an intravenous infusion within the past 30 days
- I am not currently using anti-coagulants
- I do not have a current cardiac condition requiring a pacemaker
- I have not had previous surgery for peripheral arterial disease
- I do not have a history of bilateral lymph node dissection in the arms or legs
- I do not have sickle-cell disease
- I do not have a history of ulcers to the extremities
- I do not have a history of vascular disease, or signs or symptoms of vascular disease or vascular insufficiencies to the extremities
- I am not currently taking beta blockers or calcium channel blockers for heart arrhythmia. Beta blockers or calcium channel blocker for hypertension is allowed with medical records to confirm (current within 90 days of study participation).
- I have not had an adverse reaction or known allergy to Lidocaine
- I have not had an adverse reaction or known allergy to heparin, including prior history of heparin induced thrombocytopenia
- I do not have a history of any significant allergies or reactions to any drugs
- I have documented problems having blood drawn in either arm