Autologous Volar Fibroblast Injection Into the Stump Site of Amputees (NCT03947450) | Clinical Trial Compass
RecruitingPhase 2
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
United States50 participantsStarted 2019-09-05
Plain-language summary
This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.
Who can participate
Age range
18 Years – 65 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:
Patients interested in study participation must meet all of the following inclusion criteria:
* May be male or female
* Must be between 18 years and 65 years of age
* Must have a below the knee amputation.
* Must be using a prosthetic for the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month.
* In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained within 7 days before baseline for which the investigator identified no clinically significant abnormality.
* Be able to comprehend the informed consent document and provide consent for participation
* Females of childbearing potential must:
* have a negative pregnancy test at screening
* agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study
* be willing to use a reliable form of contraception during the study
* Be willing and able to comply with the scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.
Exclusion Criteria:
Patients meeting any of the following criteria will be ineligible for study participation:
* A skin erosion deeper than the skin dermis.
* Having received any investigational drug within 30 days prior to study entry
* An allergy history to any study materials including local anesthetic, dimethyl sulfoxid…
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.