Cellular Reprogramming-Enhanced Skin Grafting for Diabetic Foot Ulcers (CREST-DFU)

Intraoperative Cellular Reprogramming-Enhanced Skin Transplantation for Diabetic Foot Ulcers: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Procedure: skin graft; Device: autologous skin cell

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: skin graft; split-thickness skin graft as control group	Procedure: skin graft; split-thickness skin graft
Experimental: autologous skin cell; autologous skin cell with skin graft	Device: autologous skin cell; autologous skin cell and skin graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healing rate	Incidence of complete wound healing within 2 weeks, defined as epithelialization without drainage confirmed by blinded assessors.	postsurgery week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrent rate	Ulcer recurrence rate during 12-month follow-up; Incidence of adverse events and complications.	postsurgery months 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication rate	Record total days to healing for both groups.	To support Kaplan-Meier analysis, participants are followed weekly (or daily via remote monitoring) to record the exact date of complete epithelialization.

Collaborators and Investigators

• Sponsor: Hu Zhicheng
• Investigators: Principal Investigator: Jiayuan Zhu, PI, Department of Burns, The First Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: February 22, 2014
• First Submitted That Met QC Criteria: February 22, 2014
• First Posted (Estimated): February 25, 2014

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcer; Autologous skin cell
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot; Therapeutics; Surgical Procedures, Operative; Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Plastic Surgery Procedures; Tissue Transplantation; Dermatologic Surgical Procedures; Skin Transplantation
• Other Study ID Numbers: SYSU-2013-048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No