Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT02638532
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 years or older, basically healthy and able to provide informed consent.
2. Patients with forefoot or rearfoot pain overlying the bone with fat pad atrophy.
3. At least 6 months post any surgical intervention to the foot.
4. Willing and able to comply with follow up examinations, including ultrasounds, MRI, and pedobarographic studies.
5. Diabetics: Type I and II with a HgA1C \< or = 7.
6. Have tried and failed at least one form of conservative management (i.e. orthotics, padding, etc.).
Exclusion Criteria:
1. Age less than 18 years.
2. Inability to provide informed consent
3. Feet with open ulcerations or osteomyelitis.
4. Diabetics: Type I and II iwth a HgAIC \> 7.
5. Active infection anywhere in the body.
6. Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment.
7. Known coagulopathy.
8. Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
9. Pregnancy.
10. Subjects with a diagnosis of Schizophrenia or Bipolar Disorder due to the inability to comply with study instructions, due in part to comorbidities (Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion).
11. Tobacco use: Last use within 1 year per patient report.
12. Patients with heart pacemakers, aneurysm clips, ear implants, IUD, shrapnel or metallic fragments in or on the body or eyes, neuro-stimulators, or other metal devices.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02638532
Study Brief:
Protocol Section:
NCT02638532