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CompletedNCT02070835CREST-DFUUpdated Feb 18, 2026

Cellular Reprogramming-Enhanced Skin Grafting for Diabetic Foot Ulcers

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

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Diabetic Foot Ulcer

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Keywords

  • Diabetic Foot Ulcer
  • Autologous skin cell
03

In context

Diabetic Foot

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 →

Lead sponsor

Hu Zhicheng is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. .Adults aged ≥18 years with type 1 or type 2 diabetes mellitus, diagnosed according to WHO criteria.
  2. .Presence of a chronic diabetic foot ulcer located below the ankle, classified as Wagner grade 2-3, with a post-debridement area of 5-80 cm².
  3. .Target ulcer present for ≥4 weeks and unhealed despite ≥4 weeks of standard wound care prior to randomization.
  4. .HbA1c \<12%, measured at screening or within 3 months prior to randomization.
  5. .Any revascularization of the affected limb completed ≥4 weeks before randomization.
  6. .Ability to provide written informed consent and comply with all study procedures and follow-up requirements.

Exclusion criteria

Exclusion Criteria:

  1. .Active infection of the target ulcer requiring systemic antibiotics, or presence of non-removable necrosis, purulence, or sinus tracts.
  2. .Significant peripheral arterial disease, defined as ABI \<0.7 or >1.3.
  3. .End-stage renal disease or eGFR \<20 mL/min/1.73 m².
  4. .Active malignancy, uncontrolled autoimmune disease, or current use of systemic immunosuppressive therapy.
  5. .Hematologic disorders that may impair wound healing.
  6. .HIV infection or active hepatitis.
  7. .Revascularization of the affected limb planned or performed within 4 weeks prior to randomization.
  8. .Participation in another interventional clinical trial within 3 months prior to randomization.
  9. .Pregnancy, lactation, or intention to become pregnant during the study period.
  10. .Any condition that, in the investigator's judgment, could impair informed consent, protocol compliance, patient safety, or data reliability.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    autologous skin cell

    autologous skin cell with skin graft

    Device: autologous skin cell

  • Active comparator
    skin graft

    split-thickness skin graft as control group

    Procedure: skin graft

Interventions

  • Deviceautologous skin cell

    autologous skin cell and skin graft

  • Procedureskin graft

    split-thickness skin graft

06

What researchers measure

Primary outcomes

  1. healing rate

    Incidence of complete wound healing within 2 weeks, defined as epithelialization without drainage confirmed by blinded assessors.

    Time frame: postsurgery week 2

Secondary outcomes

  1. recurrent rate

    Ulcer recurrence rate during 12-month follow-up; Incidence of adverse events and complications.

    Time frame: postsurgery months 12

Other outcomes

  1. 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.

07

Study locations

1 site
  • Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 20, 2017

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02070835
Lead sponsor
Hu Zhicheng
Responsible party
Hu Zhicheng (FirstSunYetSen, First Affiliated Hospital, Sun Yat-Sen University) — Sponsor-investigator
First posted
Feb 25, 2014
Start date
Aug 1, 2017
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023
Last update
Feb 18, 2026

Study contacts

Jiayuan Zhu, PI
principal investigator · Department of Burns, The First Affiliated Hospital, Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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