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The study of composite skin grafting over human acellular dermal matrix scaffold for treating diabetic low extremity ulcers

The study of composite skin grafting over human acellular dermal matrix scaffold for treating diabetic low extremity ulcers - composite skin grafting for diabetic low extremity ulcers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013225
Enrollment
80
Registered
2014-02-22
Start date
2010-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic low extremity ulcer is one of the refractory wounds and always poses therapeutic challenges.

Interventions

patients received a split-thickness autograft combined with ReCell(experimental group) patients received split-thickness autograft alone (control group)

Sponsors

Department of Burn Surgery The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged over eighteen years old with a diagnosis of type 1 or type 2 diabetes, who had a diabetic low extremity ulcer last for over four weeks, with a stage 2 by Wagner's scale, and size more than three cm2, absence of vascular reconstruction (ankle brachial indices between 0.7 and 1.2) and had indications of skin grafting were eligible for inclusion

Exclusion criteria

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%)

Design outcomes

Primary

MeasureTime frame
Effectiveness

Secondary

MeasureTime frame
safety

Countries

Asia(except Japan)

Contacts

Public ContactZhicheng Hu

The First Affiliated Hospital of Sun Yat-sen University Department of Burn Surgery

willway128@163.com+86-20-87755766-8235

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026