Testing Autologous Palm or Sole Skin Cell Injections to Improve Skin Thickness and Strength at the Amputation Stump Site in Adults with Below the Knee Amputations

What this Trial Is About

Researchers are evaluating the safety and effectiveness of injecting volar fibroblasts, which are skin cells from the palm or sole, to thicken the epidermal layer at the stump site of adults with below the knee amputations. This Phase 2 clinical trial aims to improve skin firmness and thickness at the stump, which may help reduce skin breakdown caused by pressure and friction from prosthetic use. The study is conducted at Johns Hopkins University and focuses on preventing skin problems in amputees. Participants will receive injections of their own autologous skin fibroblasts or a placebo into the whole stump or localized areas. The trial uses a crossover design where some participants receive the fibroblast injections while others receive placebo injections, allowing comparison within the same individual or between groups. Injections target the entire stump, especially pressure-intolerant skin areas that contact the prosthetic socket. The study evaluates different injection methods for safety and effectiveness and observes effects on prosthetic use, skin breakdown, quality of life, and activity levels. During the study, participants will undergo assessments including questionnaires, non-invasive imaging, and skin firmness measurements. Researchers will monitor safety primarily by tracking hospitalizations over 12 months and evaluate changes in skin breakdown at baseline and one month. Participants will comply with scheduled visits, biopsies, injections, and wound care instructions throughout the trial. The study enrollment includes adults aged 18 to 65 with below the knee amputations who have been using a prosthetic for at least three months or have osteo-integration of a prosthetic for at least one month.

Autologous Volar Fibroblast Injection Into the Stump Site of Amputees