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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 autologous skin cell with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous skin cell | Experimental | autologous skin cell with skin graft |
|
| skin graft | Active Comparator | split-thickness skin graft as control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous skin cell | Device | autologous skin cell and skin graft |
| |
| Measure | Description | Time Frame |
|---|---|---|
| healing rate | Incidence of complete wound healing within 2 weeks, defined as epithelialization without drainage confirmed by blinded assessors. | postsurgery week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| recurrent rate | Ulcer recurrence rate during 12-month follow-up; Incidence of adverse events and complications. | postsurgery months 12 |
| Measure | Description | Time Frame |
|---|---|---|
| complication rate | Record total days to healing for both groups. | To support Kaplan-Meier analysis, participants are followed weekly (or daily via remote monitoring) to record the exact date of complete epithelialization. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Zhu, PI | Department of Burns, The First Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2017 | Feb 13, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D016038 | Skin Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| skin graft |
| Procedure |
split-thickness skin graft |
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D062109 |
| Dermatologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |