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
• Status: Completed
• Phase: N/A
• 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
• 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%)

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

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