Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers

February 6, 2024 updated by: Hu Zhicheng

Autologous Skin Cell Versus Classic Skin Grafts in Treatment of Diabetic Foot Ulcers: a Comparative Randomized Controlled 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

Intervention / Treatment

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)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged over 18 years old
  • with a diagnosis of type 1 or type 2 diabetes
  • who had a diabetic low extremity ulcer last for over 4 weeks
  • with a stage 2 by Wagner's scale
  • size more than 3 cm2
  • absence of vascular reconstruction (ankle brachial indices between 0.7 and 1.2)
  • had indications of skin grafting were eligible for inclusion

Exclusion Criteria:

  • patients with medical conditions that would impair wound healing (e.g. malignancy, autoimmune disease),
  • using corticosteroids or immunosuppressor
  • a high anesthesiology or surgical risk
  • uncontrolled hyperglycemia (preoperative HbA1c greater than 12.0%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: postsurgery week 4
the percentage of subjects that achieved complete wound closure by week 4, herein complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements
postsurgery week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrent rate
Time Frame: postsurgery months 6
the incidence of ulcer recurrence at months 6. Recurrence will be defined as an ulcer occurring at the same location as the healed study ulcer
postsurgery months 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
complication rate
Time Frame: postsurgery week 4
the percentage of subjects that who could not achieved complete wound closure by week 4
postsurgery week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hu Zhicheng

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2022

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 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-2013-048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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