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Fibroblast Injection for Amputation Healing
Study Summary
This trial is testing whether injecting skin cells from the palm or sole can thicken the skin layer at the site of an amputation below the knee, in order to improve healing.
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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- I have had an amputation below the knee.I have been using a prosthetic for at least 3 months or had one integrated into my bone for 1 month.I have dead tissue on my amputation site or slow blood return in the skin.I am not on long-term immunosuppressive treatments, including oral or topical steroids.You have taken any experimental medication within the last month before joining the study.You have had keloids in the past.My doctor thinks my medical history makes it unsafe for me to join the study.I have a skin wound that is deeper than the outer layer of my skin.I have a known bleeding disorder.I have a history of severe allergies, like anaphylaxis.I am either male or female.I am between 18 and 65 years old.I am of childbearing age and my pregnancy test was negative.I am willing to use birth control during the study.I have an infection in the part of my body where a limb was amputated.I have been using a prosthetic for less than 3 months.I have had a limb amputated and developed a painful nerve growth in the last 3 months.I have a history of blood disorders or take medications that can affect my blood.I agree not to become pregnant or breastfeed during and for 1 month after the study.You are currently smoking cigarettes during the study.I do not have an autoimmune disease like lupus affecting my skin.
- Group 1: Control
- Group 2: Autologous skin fibroblasts
- 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
Is this trial enrolling participants currently?
"According to the clinicaltrials.gov data, this experiment is still seeking participants and has been open since September 5th 2019, with its last revision on June 8th 2022."
Has the FDA provided clearance for Autologous Skin Fibroblasts?
"As this is a Phase 2 trial, the safety of Autologous Skin Fibroblasts has been provisionally evaluated at a score of two due to limited evidence on efficacy."
Are participants who are of an advanced age being enrolled in this research?
"This clinical trial outlines that patients aged 18 to 65 are eligible for inclusion. For those younger than 18 and older than 65, there exists 3 other trials tailored towards their age ranges."
Am I eligible to partake in this experiment?
"This clinical trial is enrolling 50 individuals, aged 18 and 65 who have had amputations. To qualify for the research study patients must also fulfill these requirements: demonstrate a negative pregnancy test at screening, be male or female between 18-65 years old with below-knee amputation; use a prosthetic device possess 3 months of experience or undergone osteo-integration of a prosthetic one month prior to entry into the trial; agree not to become pregnant/breastfeed during their participation and 1 month after completion; adhere to all scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other related"
How many individuals are partaking in this experiment?
"Affirmative. The records on clinicaltrials.gov demonstrate that this medical trial, which was originally published on September 5th 2019, is actively recruiting participants. A total of 50 individuals are needed to be recruited from 1 site in order for the study to move forward."
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