Plain-English translation of NCT04839497 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing autologous volar fibroblast injections—cells taken from your own skin—to see if they can improve the health and comfort of skin on your residual limb after a lower leg amputation. Half of the participants will receive injections of these cells, while the other half will receive a placebo injection. Researchers want to know if this treatment is safe and whether it makes the skin firmer and less prone to problems.
People who wear prosthetics often experience skin breakdown, pain, and discomfort on their residual limbs. This medication is being tested to see if it can strengthen and thicken the skin naturally, potentially reducing these problems and improving quality of life for amputees.
You likely qualify if…
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You will start by having a small skin biopsy taken from your arm so your cells can be grown in the laboratory. Once ready, you will receive either the cell injections or a placebo injection over the course of one week. After that, you will visit the clinic at 2 weeks, 1 month, 2 months, and 3 months to have your skin checked, measured, and evaluated. If you received the placebo, you will have the option to receive the real treatment after your final visit and be followed for another 3 months.
AI-generated summary from trial data · Oct 12, 2026 · Not medical advice
United States