An interventional study of autologous skin cell and skin graft in Diabetic Foot Ulcer, sponsored by Hu Zhicheng. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Hu Zhicheng · Not applicable, Interventional, and Treatment
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 108 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Hu Zhicheng is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
autologous skin cell with skin graft
Device: autologous skin cell
split-thickness skin graft as control group
Procedure: skin graft
autologous skin cell and skin graft
split-thickness skin graft
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
complication rate
Record total days to healing for both groups.
Time frame: To support Kaplan-Meier analysis, participants are followed weekly (or daily via remote monitoring) to record the exact date of complete epithelialization.
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Hu Zhicheng