Li 2012.
| Methods | Design: Prospective randomised controlled trial Number of participant centres: 1 Setting: Department of Diabetic Ulcers Centre in West China Hospital of Sichuan University Country: China Unit of randomisation: the patient Unit of analysis: the ulcer Follow‐up: 12 weeks |
|
| Participants | Number randomised (patients): 117 (59 in experimental group and 58 in control group) Number ulcers: 117 Wound aetiology: diabetic ulcer Age: not reported Sex: Both (75 men/42 women) Inclusion criteria: Duration of ulcers before been admitted to hospital > 2 weeks After 2 weeks treatment in hospital, including blood sugar/blood pressure control; anticoagulation; anti‐infection; standard usual care for ulcers (debridement, drainage, pressure reduce, dressing change), there is no improvement – defined as “non‐healing diabetic ulcers” Written consent from patients/patients family |
|
| Interventions | Experimental group: Autologous platelet gel + usual care Autologous platelet gel was prepared by applying two‐level manual differential centrifugation and is mixed with thrombin‐calcium at 10:1 ratio. Autologous platelet gel treatment every 2 weeks Suile Wound Dressing changes every 3 days and photographed Control group: Usual care (debridement; a Suile Wound Dressing (Hedonist Biochemical Technologies Co. Ltd, USA); a secondary dressing. The Suile Wound Dressing was changed every 3 days and photographed) Length of treatment: 12 weeks or until ulcer healed |
|
| Outcomes | Complete healing Length of healing Expenditure Length of stay in the hospital |
|
| Notes | This paper is in Chinese | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: The random sequence was generated using a computer random number generator |
| Allocation concealment (selection bias) | Unclear risk | Comment: Not stated |
| Blinding of participants (performance bias and detection bias) | Unclear risk | Comment: Not stated |
| Blinding of personnel (performance and detection bias) | Unclear risk | Comment: Not stated |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “after the following‐up of the study, a researcher who is responsible for collecting the data (the photos) of the study did the analysis and measurements of the ulcers, using software Image J 1.46 h” Comment: The assessor was blinded to the intervention. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: The data of all included patients were reported |
| Selective reporting (reporting bias) | Low risk | Comment: There were results of all variables listed in methods |