Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers

Study Overview
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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 ReCell® technology 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 ReCell® 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.

Official Title
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ReCell® Versus Classic Skin Grafts in Treatment of Diabetic Foot Ulcers: a Comparative Randomized Controlled Trial

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: autologous skin cell
* Procedure: skin graft


Participation Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous skin cell<br>autologous skin cell with skin graft | Device: autologous skin cell<br>* autologous skin cell and skin graft<br>|
| Active Comparator: skin graft<br>split-thickness skin graft as control group | Procedure: skin graft<br>* split-thickness skin graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer, ReCell