Impaired Wound Healing in Diabetic Foot Ulceration
United States137 participantsStarted 2006-12
Plain-language summary
An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. The study also examines the association of a specific type of cell with the rate of wound healing.
Who can participate
Age range
21 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Current diagnosis of Type I or Type II Diabetes Mellitus.
* Ulcer present for minimum 4 weeks
* Have adequate circulation to the foot
* Can return for follow-up visits
* Be able to read and sign the Informed Consent form before enrollment
Exclusion Criteria:
* Active Charcot's foot ulcer on the foot to be studied
* Presence of any serious disease that can affect wound healing including end stage renal failure requiring hemodialysis or renal transplantation, active malignant disease requiring treatment, hepatic, hematologic, neurologic, or immune disease
* Alcohol or drug abuse problems
* Treatment with oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
* Presence of infectious disease that can preclude EPC measurements (including HIV, Hepatitis B and C)
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.