A randomized controlled trial evaluating the effectiveness of autologous fibroblast culture in the healing of chronic venous leg ulcers at a tertiary care hospital in Sri Lanka

Background: Chronic venous leg ulcers are a common cause of morbidity and reduced quality of life, with many ulcers demonstrating delayed healing despite standard compression therapy. Fibroblasts play a central role in wound healing, and autologous fibroblast culture has emerged as a potential adjunctive therapy for chronic wounds. This study evaluated the effectiveness of autologous fibroblast culture combined with compression therapy in the healing of chronic venous leg ulcers.
Methods: A randomized controlled trial was conducted at the National Hospital of Sri Lanka from August 2019 to March 2020. Adults with chronic venous leg ulcers were randomized to either an experimental group receiving autologous fibroblast culture suspended in collagen mesh with four-layer compression therapy or an active control group receiving collagen mesh with compression therapy alone. Ulcer area was assessed weekly for 12 weeks using digital planimetry. Percentage reduction in ulcer area from baseline was analysed using a linear mixed-effects model to compare healing trajectories between groups.
Results: Nineteen participants were enrolled, and 17 completed the study (8 experimental, 9 active control). Complete ulcer healing was not observed in either group within the 12-week follow-up period. However, the experimental group demonstrated a significantly faster rate of ulcer healing over time compared with the active control group. Linear mixed-effects analysis showed a significant interaction between treatment group and time (β = 0.271, SE = 0.082, P = 0.001), indicating a greater reduction in ulcer area in the experimental group. No clinically significant adverse events were observed during follow-up.
Conclusion: Autologous fibroblast culture combined with compression therapy showed a favourable trend in healing chronic venous leg ulcers compared with compression therapy alone. The intervention appeared safe and may have potential as an adjunctive therapy. Larger studies with longer follow-up and stronger statistical power are required to establish efficacy, practicality, and cost-effectiveness.