Cellular Reprogramming-Enhanced Skin Grafting for Diabetic Foot Ulcers

NCT02070835 | Completed DMC

• 1 other identifier: SYSU-2013-048
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer; Autologous skin cell

Outcome Measures

Primary Outcomes (1)

• healing rate

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

  postsurgery week 2

Secondary Outcomes (1)

• recurrent rate

  postsurgery months 12

Other Outcomes (1)

• complication rate

  To support Kaplan-Meier analysis, participants are followed weekly (or daily via remote monitoring) to record the exact date of complete epithelialization.

Study Arms (2)

autologous skin cell

EXPERIMENTAL

autologous skin cell with skin graft

Device: autologous skin cell

skin graft

ACTIVE COMPARATOR

split-thickness skin graft as control group

Procedure: skin graft

Interventions

autologous skin cell DEVICE

autologous skin cell and skin graft

autologous skin cell

skin graft PROCEDURE

split-thickness skin graft

skin graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years with type 1 or type 2 diabetes mellitus, diagnosed according to WHO criteria.
• 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.
• Target ulcer present for ≥4 weeks and unhealed despite ≥4 weeks of standard wound care prior to randomization.
• HbA1c \<12%, measured at screening or within 3 months prior to randomization.
• Any revascularization of the affected limb completed ≥4 weeks before randomization.
• Ability to provide written informed consent and comply with all study procedures and follow-up requirements.

You may not qualify if:

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

Sponsors & Collaborators

• Hu Zhicheng: lead

Study Sites (1)

Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Skin Transplantation

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Jiayuan Zhu, PI

  Department of Burns, The First Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: FirstSunYetSen

Study Record Dates

• First Submitted: February 22, 2014
• First Posted: February 25, 2014
• Study Start: August 1, 2017
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CN (1)