Study of Skin Cells That Stop Replicating (Senescent) During Wound Healing (NCT02755584) | Clinical Trial Compass
CompletedNot Applicable
Study of Skin Cells That Stop Replicating (Senescent) During Wound Healing
United States75 participantsStarted 2016-06-30
Plain-language summary
Background:
Cellular senescence is the aging of cells. It is a complex process that may be connected with aging and age-related diseases. It is unknown if these cells appear around wound sites in humans a few days after skin injury and if there are differences in young and old individuals. This study is being done to look at how cells in your body respond to small skin wounds. This information may help treat age-related diseases.
Objective:
To study how cells in the body respond to small skin wounds.
Eligibility:
Healthy adults ages 20-39 or 70+
Design:
Participants will be screened with medical history, physical exam, and blood sample. They will fast before the screening visit. Women will have a urine pregnancy test.
Participants will have 3 study visits over about 3 weeks.
Visits 1 and 2: Participants will fast before and have blood taken. Women will have a urine test. All participants will have 2 skin biopsies. A spot on the upper arm will be numbed. Two small pieces of skin will be removed. They will keep the area covered until the next visit.
Visit 3: Participants will have their vital signs taken. Their biopsy wounds will be measured and photographed.
Who can participate
Age range
20 Years
Sex
ALL
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:
* Age 20 - 39 years or age 70 years and older.
* Healthy (see exclusion criteria below).
* Are able to understand the study risks and procedures, and consent to participate in the study.
* Are able to read and speak English.
* Caucasian or African American
* Previous enrolled participants.
EXCLUSION CRITERIA (SCREENING VISIT):
* A medical condition that requires the use of chronic anticoagulant medication use such as warfarin, clopidogrel, heparin or antiplatelet agents other than low dose aspirin (81mg).
* History of increased bleeding due to either a known medical condition or an undiagnosed cause.
* A medical condition that causes impaired wound healing such as diabetes.
* Current androgenic/anabolic and/or corticosteroid use or use within 90 days of the procedure (ocular corticosteroid use okay).
* Current antibiotic or anti-viral use or use within 60 days of the procedure.
* Active infections or chronic skin conditions that would prevent access to the biopsy area.
* Taking non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen) and the
participant is unable to stop taking them 3 days before the biopsy and 1 day after the biopsy procedure.
* Taking more than 81 mg of aspirin a day and the participant is unable to stop taking it for 3 days before the biopsy and 1 day after the biopsy procedure.
* Allergic to Lidocaine (Xylocaine) or any other local anesthetic or the participant has had i…
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.
1This trial studied healthy volunteers — if I'm not in perfect health, does that affect whether findings from this research would even apply to my situation?
2Since this study was specifically looking at whether senescent cells appear around wound sites after a skin injury, what does my doctor think the practical implications of that finding might mean for how wounds heal in my case?
3This trial has already been completed — is there published data or results from it that my doctor has seen, and if so, what did it actually show about senescent cells in healing skin?
4Since this was labeled 'Phase NA,' meaning it wasn't testing a treatment but rather observing a biological process, how does my doctor see this kind of basic science research connecting to any actual treatment decisions for me?
5If senescent cells do play a role in wound healing, are there any follow-up trials or therapies being developed based on findings like these that my doctor thinks might eventually be relevant to my care?
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.
What they're measuring
1
To demonstrate that in humans, senescent cells will appear around wound sites after skin injury.
Timeframe: Basline visit 1and visit 2 six different days