Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: autologous skin cell; Procedure: skin graft

• Registration Number: NCT02070835
• Lead Sponsor: Hu Zhicheng

Brief 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.

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 Timeline

• Study First Submitted: 2014-02-22
• Study First Submitted QC: 2014-02-22
• Study First Posted: 2014-02-25
• Study Start: 2014-04
• Primary Completion: 2021-12
• Study Completion: 2022-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
autologous skin cell	autologous skin cell	autologous skin cell with skin graft
skin graft	skin graft	split-thickness skin graft as control group

Primary Outcome Measures

Name	Time	Method
healing rate	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

Secondary Outcome Measures

Name	Time	Method
recurrent rate	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

Trial Locations

Locations (1)

Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China