Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers

Hu Zhicheng

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Procedure: skin graft; Device: autologous skin cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02070835

SYSU-2013-048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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%)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

autologous skin cell

Experimental group

Description:

autologous skin cell with skin graft

Treatment:

Device: autologous skin cell

skin graft

Active Comparator group

Description:

split-thickness skin graft as control group

Treatment:

Procedure: skin graft