Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. This study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the autologous skin cell with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.
The primary objective of this study is to assess the effectiveness and safety of autologous skin cell with skin graft (experiment group) vs. skin graft (control group) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that the methods of experiment group is better than the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
autologous skin cell and skin graft
split-thickness skin graft
Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
healing rate
Incidence of complete wound healing within 2 weeks, defined as epithelialization without drainage confirmed by blinded assessors.
Time frame: postsurgery week 2
recurrent rate
Ulcer recurrence rate during 12-month follow-up; Incidence of adverse events and complications.
Time frame: postsurgery months 12
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