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NCT02070835 Clinical Trial

Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02070835
Other study ID # SYSU-2013-048
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date December 2022

Study information
Verified date February 2024
Source First Affiliated Hospital, Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, control group) alone on treating diabetic foot ulcers.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• autologous skin cell
autologous skin cell and skin graft
Procedure:
• skin graft
split-thickness skin graft

Locations
Country Name City State
China Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Hu Zhicheng

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other complication rate the percentage of subjects that who could not achieved complete wound closure by week 4 postsurgery week 4
Primary healing rate 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 recurrent rate 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
See also
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Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A