Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers

NCT ID: NCT02070835

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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autologous skin cell

autologous skin cell with skin graft

Group Type EXPERIMENTAL

autologous skin cell

Intervention Type DEVICE

autologous skin cell and skin graft

skin graft

split-thickness skin graft as control group

Group Type ACTIVE_COMPARATOR

skin graft

Intervention Type PROCEDURE

split-thickness skin graft

Interventions

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autologous skin cell

autologous skin cell and skin graft

Intervention Type DEVICE

skin graft

split-thickness skin graft

Intervention Type PROCEDURE

Eligibility Criteria

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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%)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hu Zhicheng

OTHER

Sponsor Role lead

Responsible Party

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Hu Zhicheng

FirstSunYetSen

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jiayuan Zhu, PI

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SYSU-2013-048

Identifier Type: -

Identifier Source: org_study_id

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