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Fibroblast Injection for Amputee Limb Care
Study Summary
This trial will test injections of volar fibroblasts to improve skin firmness for amputees. Participants will be randomly assigned to receive injections or a placebo. Monitored for 3 months.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My skin is healthy and I don't have severe skin conditions or non-healing wounds.I have a known bleeding disorder.I have ulcers larger than 4cm across.I am a quadriplegic.I am not pregnant, won't get pregnant or breastfeed during the study, and will use birth control.I have a history of blood disorders or take medications that can affect my blood.I am an amputee with painful nerve growths in my limb stump from the last 3 months.I have dead tissue on my amputation stump or slow blood return in stump skin.I am currently smoking or using tobacco products.I am not on long-term immunosuppressive treatments, including oral or topical steroids.I do not have an infection in my amputated limb.I have an autoimmune skin condition like lupus.My doctor thinks my medical history makes it unsafe for me to join the study.I have been using a prosthesis for 3 months or had one integrated into my bone for 1 month.I have a skin wound that is deeper than the outer layer of my skin.My ulcers can't be treated with a wide margin of healthy tissue around them.I have had an amputation below the knee.I am between 18 and 75 years old.
- Group 1: Volar Fibroblast Treatment
- Group 2: Cryoprotectant
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Might I be a suitable candidate for this particular experiment?
"Participants between 18 and 75 years of age who have experienced amputation are eligible for selection in this trial. The medical team seeks to accept up to 20 people into the study."
How many participants will be admitted to this clinical experiment?
"Indeed, the information on clinicaltrials.gov indicates that this medical trial is actively enrolling participants. The listing was first created on September 26th 2022 and last modified April 20th 2023. Twenty patients are expected to be admitted from a single healthcare setting."
Is it possible to join this medical research program at the present?
"The information available on clinicaltrials.gov suggests that this medical trial is accepting participants right now. It was originally posted in September 26th 2022 and has been revised most recently on April 20th 2023."
Are applicants who have exceeded the age of 20 able to participate in this experiment?
"The guidelines for this experiment dictate that participants must be between 18 and 75 years of age. Furthermore, there are 1 trails available to younger individuals and 67 trials accessible to senior citizens."
Has the Volar Fibroblast Treatment been validated by regulatory authorities?
"The safety of Volar Fibroblast Treatment has been judged to be a 2 on our team's scale, as there is some evidence that suggests its safety but none verifying efficacy due to this being an early stage Phase 2 trial."
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