Multicentre randomized controlled clinical trial of acellular allogeneic dermal matrix combined with autologous skin graft for the repair of diabetic foot ulcers

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026711

Enrollment

Unknown

Registered

2019-10-19

Start date

2019-10-20

Completion date

Unknown

Last updated

2019-10-21

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

Conditions

diabetic foot

Interventions

The experimental group:Acellular allogeneic dermis composite autologous skin graft

The control group:Conventional autologous skin graft?

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The age of the subject on the date of signing the informed consent is 18 years or above; 2. Type 2 diabetes; 3. Diabetic foot ulcer lasting 2 weeks or more; 4. Wagner was rated as level 2 or level 3. If Wagner was rated as level 4-5, those who needed skin grafts after toe amputation/amputation could also be included; 5. Wound surface area: 3cm^2; 6. Brachial and malleolus index was between 0.7 and 1.2; 7. The vital signs were stable. 8. Patients with good mental state can follow the doctor's advice, regular visit; 9. Understand and be willing to participate in this clinical trial and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Difficult to control hyperglycemia (e.g. HbA1c >12.0%); 2. Patients developed immunosuppression during the screening period due to long-term immunosuppressive treatment of underlying diseases or high doses of glucocorticoid (i.e., 40 mg prednisone or equivalent prednisone daily for 2 weeks); 3. Patients with combined mental diseases; 4. Patients with severe uncontrolled diseases or systemic acute infection or other serious heart, lung and brain diseases; 5. Those deemed unsuitable for inclusion; 6. The patient is a pregnant woman who has not taken appropriate contraceptive measures and is a lactating woman during the screening period or a pregnant woman who plans to become pregnant within 1 month after the end of the study. 7. Patients were enrolled in the study at any time in the past.

Design outcomes

Primary

Measure	Time frame
Wound healing rate;The recurrence rate;	—

Secondary

Measure	Time frame
Vancouver scale score;	—

Countries

China

Contacts

Public ContactBing Tang

The First Affiliated Hospital of Sun Yat-Sen University

tangbing@mail.sysu.edu.cn+86 13802502299

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026