Autologous Volar Fibroblast Injections for Amputation
This study is looking at a treatment called Autologous Volar Fibroblast Injection for people who have had a transtibial (below-the-knee) amputation. This treatment uses your own skin cells, called fibroblasts, taken from your palm or sole (volar skin), to see if they can make the skin on your residual limb firmer. Researchers want to know if this treatment is safe and if it helps improve skin firmness. You could be eligible if you are 18-75 years old, have a transtibial amputation, and use a prosthesis. The study plans to enroll 20 participants, but its current recruitment status is unclear.
- Study design
- This study will enroll 20 adults and randomly assign them to either receive the fibroblast injections or a control treatment. This means you have an equal chance of receiving the active treatment or a placebo.
- What's involved
- You would undergo a skin biopsy to collect cells, have injection sites tattooed, and receive injections on your residual limb over 1 to 3 days within one week.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess safety and skin firmness from when you start until 3 months after your injection visit.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.
At a glance
Conditions
NCT04839497
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Johns Hopkins Hospital
Baltimore, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety assessment of complications and adverse events associated with Volar Fibroblast injections3 months from the injection visit
Safety will be evaluated by routinely assessing all complications at each study visit. Minor and expected complications may include local injection reactions like bruising and erythema, swelling and pain. Minor complications that are not expected include local small hemorrhage (x\<1mL), edema, nodules, papules, irritation, dermatitis, pruritus, and cellulitis. Serious Adverse Events are defined as unexpected AND serious AND related or possibly related to the study treatment. These may include but are not limited to osteomyelitis.
- Efficacy of autologous volar fibroblasts for increasing skin firmness in individuals with a transtibial amputation.Baseline through 3 months from the injection visit
Efficacy will be determined by treatment group difference in the pre- post-change in skin firmness at three months post injection. Skin firmness is the level of resistance as measured by a non-invasive hand-held durometer