Randomised controlled clinical trial for autologous fibroblast-hyaluronic acid complex in treating diabetic foot ulcers.
OBJECTIVE
Diabetic foot ulcers (DFUs) often pose a treatment problem. Bioengineered skin substitutes have been reported to result in accelerated diabetic wound healing. The purpose of this clinical trial was to evaluate the efficacy and safety of the autologous fibroblast-hyaluronic acid complex for treating DFUs.


METHODS
A stratified, randomised, controlled, multicentre study was carried out. Patients with DFUs were allocated to either a treatment group with grafting of an autologous fibroblast-hyaluronic acid complex or a control group with non-adherent foam dressing. Except for application of the fibroblast complex, treatment of the study ulcers was identical for patients in both groups. The maximum follow-up period for each patient was 12 weeks.


RESULTS
Complete ulcer healing was achieved in 84% (26/31 patients) of the treatment group and 34% (11/32 patients) of the control group (p<0.05). The times required for complete healing were 36.4 ± 17.6 and 48.4 ± 13.1 days in the treatment and control groups, respectively (p<0.05). No adverse events related to treatment occurred.


CONCLUSIONS
These results indicate that autologous fibroblast-hyaluronic acid complex may offer a safe and effective treatment for DFUs.
Clinical Instructor, Department of Plastic Surgery, Korea University College of Medicine, Seoul, Korea.
H J
HJ
You
S K
SK
Han
J W
JW
Rhie
D000368:Aged; D064592:Autografts; D001458:Bandages; D017719:Diabetic Foot / Q000628:therapy*; D005260:Female; D005347:Fibroblasts / Q000637:transplantation*; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014945:Wound Healing
D006820:Hyaluronic Acid
diabetic foot; diabetic foot ulcer; fibroblast; hyaluronic acid; wound healing