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Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
A discharge planning program to prevent infection among patients with diabetic foot ulcers in Taiwan: A randomized
Yen-Fan Chin1, Jiun-Ting Yeh2, Hsing-Yi Yu3
1School of Nursing, College of Medicine, Chang Gung University, Taiwan, 33302; Division of Endocrinology and Metabolism, New Taipei Municipal Tu-Cheng Hospital, New Taipei, Taiwan.
Trial And Protocol Registration:
This study is registered with ClinicalTrials.gov, No. NCT04467606.
Background:
Patients hospitalized for foot ulcers have a high readmission rate due to wound infections, and treating these infections is costly.
Aims:
This study aimed to investigate the effect of a discharge planning program that uses a motivational interviewing strategy (MI) on infection prevention in patients with diabetes-related foot ulcers (DFUs).
Methods:
A randomized controlled trial was conducted at a hospital in Taiwan from August 2020 to October 2022. A total of 132 hospitalized adult patients with DFUs were recruited and randomized into either MI or control group in a 1:1 ratio by block randomization, with 66 patients in each group. In the MI group, the interview was conducted at least one day before discharge, within three days after discharge, and then weekly for the first month and every one to three months thereafter. The control group received the usual care. The Diabetes Foot Self-Care Behavior Scale (DFSBS) and Diabetes-related Foot Ulcer Self-Management Behavior Scale (DFUSMB) were used to collect foot self-care and DFU self-management behaviors. Infectious status was determined according to the IWGDF/IDSA classification. Cox regression and generalized estimating equation (GEE) were used for data analysis.
Results:
After adjusting for significant variables, the univariate Cox regression analysis results showed no statistically significant difference in foot infection or readmission rates between the two groups. In the GEE analysis, after adjusting for covariates, the results showed that the foot self-care behaviors of patients in the intervention group after discharge were better than those in the control group, reaching statistical significance. However, behaviors specific to DFU self-management were not statistically significant.
Conclusions:
Although motivational interviewing has shown to be effective in promoting foot self-care behaviors, more research is needed on how to reduce post-discharge foot infections and hospitalizations.
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