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Own skin cells boost healing of diabetic foot ulcers in new trial

NCT ID NCT02070835

Disease control Sponsor: Hu Zhicheng Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial tested whether adding a patient's own skin cells to a standard skin graft helps diabetic foot ulcers heal better. 108 adults with hard-to-heal ulcers received either the cell-enhanced graft or a standard graft alone. The main goal was to see how many wounds fully closed within two weeks, with follow-up for a year to check for recurrence and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous skin cells (the patient's own skin cells)
What this could lead to
If successful, this approach could become a standard treatment to help diabetic foot ulcers heal faster and reduce the chance they come back.
What could go wrong
This is a single completed trial with 108 participants, so results need confirmation in larger, more diverse studies. Risks include infection, graft failure, or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

108 people

The number who actually took part.

Started

Aug 2017

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcer

Contacts and locations

Locations

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

    Guangzhou, Guangdong, 510080, China

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Other studies related to the condition(s) this trial covers.