Diabetic Foot UlcerCREST-DFUNCT02070835

Cellular Reprogramming-Enhanced Skin Grafting for Diabetic Foot Ulcers

A study testing autologous skin cell and skin graft in people with Diabetic Foot Ulcer, run by Hu Zhicheng at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot Ulcer
What is being tested?: autologous skin cell and skin graft
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteChina
Study dates: 1 Aug 2017to 30 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

.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.

Who cannot join

.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.

Show all 10Show fewer

.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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

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.

Conditions: Diabetic Foot Ulcer
Being tested: autologous skin cell, skin graft
Keywords: Diabetic Foot Ulcer, Autologous skin cell
Medical subject headings: Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

autologous skin cellDevice
autologous skin cell and skin graft
skin graftProcedure or surgery
split-thickness skin graft

Study groups in NCT02070835
Study group	Role	What they receive
autologous skin cell	Experimental	autologous skin cell with skin graft Receives: Device: autologous skin cell
skin graft	Active comparator	split-thickness skin graft as control group Receives: Procedure: skin graft

What is being measured

The primary outcome is the main question the study is designed to answer.

healing rate
Incidence of complete wound healing within 2 weeks, defined as epithelialization without drainage confirmed by blinded assessors.
Measured: postsurgery week 2

Secondary outcomes (1)

recurrent rate
Ulcer recurrence rate during 12-month follow-up; Incidence of adverse events and complications.
Measured: postsurgery months 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201730 Dec 2023

First posted25 Feb 2014 (estimated)
Study start1 Aug 2017
Primary completion30 Dec 2023
Study completion30 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02070835
Sponsor's protocol ID: SYSU-2013-048
Acronym: CREST-DFU
Status last verified: Feb 2026
First submitted: 22 Feb 2014
Last updated: 18 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer

All Diabetic Foot Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intraoperative Cellular Reprogramming-Enhanced Skin Transplantation for Diabetic Foot Ulcers: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02070835
Acronym / sponsor ID: CREST-DFU / SYSU-2013-048
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer, Autologous skin cell
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Hu ZhichengUniversity, hospital or other
Study start: 1 Aug 2017 (actual)
Primary completion: 30 Dec 2023 (actual)
Study completion: 30 Dec 2023 (actual)
First posted: 25 Feb 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
autologous skin cell	Experimental	Device: autologous skin cellautologous skin cell with skin graft
skin graft	Active comparator	Procedure: skin graftsplit-thickness skin graft as control group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

.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.

Key exclusion criteria (10 listed)

.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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
autologous skin cellautologous skin cell and skin graft	Device	autologous skin cell
skin graftsplit-thickness skin graft	Procedure or surgery	skin graft

Primary outcome

healing rate
Time frame: postsurgery week 2
Incidence of complete wound healing within 2 weeks, defined as epithelialization without drainage confirmed by blinded assessors.

1 secondary outcome

recurrent rate
Time frame: postsurgery months 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.

Related trials for Diabetic Foot Ulcer

Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jiayuan Zhu, PI principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing autologous skin cell and skin graft in people with Diabetic Foot Ulcer, run by Hu Zhicheng at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

healing rate (time frame: postsurgery week 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02070835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.