A subscription to JoVE is required to view this content. Sign in or start your free trial.
Research Article
This study developed and validated a linear regression model to predict pain during diabetic foot ulcer dressing changes in 232 patients. Ulcer area, disease duration, and Self-Rating Anxiety Scale (SAS) were key predictors. A model-based personalized analgesic regimen reduced pain, improved compliance, and enhanced ulcer healing, supporting precision pain management strategies.
This study included 232 patients with diabetic foot ulcers (DFUs) to construct and validate a linear regression model to predict pain during dressing changes and to evaluate the effectiveness of a model-based personalized analgesic care regimen. In stage 1,160 patients were divided into a training set (n = 113) and an internal validation set (n = 47); multivariable linear regression identified ulcer area, ulcer duration, duration of diabetes, and the Self-Rating Anxiety Scale (SAS) score as predictors of continuous dressing-change VAS. The model yielded an adjusted R2 of 0.458 and an RMSE of 1.719 in the training set, while the validation-set RMSE, calibration intercept, calibration slope, and AUC for identifying high pain were 2.058, 1.414, 0.721, and 0.913, respectively. In stage 2 (72 cases), subjects were assigned to a control group and an intervention group. The intervention group received a personalized analgesic regimen based on model-derived risk stratification, while the control group received conventional analgesic care. After 4 weeks, the intervention group had a lower dressing-change VAS score than the control group (3.83 ± 1.61 vs 4.94 ± 1.91, P = 0.010), together with a higher overall adherence rate (86.11% vs 63.89%, P = 0.029), a higher ulcer area reduction rate (41.84% ± 11.01% vs 26.22% ± 7.55%, P < 0.001), and a shorter wound-healing time (32.0 [29.0–35.0] vs 38.0 [34.0–43.5] days, P < 0.001). The model showed useful discrimination for dressing-change pain, and the model-based personalized analgesic regimen improved short-term pain, adherence, and wound-related outcomes; however, external validation and further refinement of model calibration are required before routine clinical implementation.
Diabetic foot ulcers (DFUs), one of the most serious chronic complications of diabetes mellitus, are associated with high morbidity, disability, and healthcare costs, substantially impairing patients' quality of life and increasing the burden on healthcare systems1. Regular wound dressing changes are an essential component of DFU management because they facilitate wound cleansing, infection control, and tissue repair. However, dressing-change pain remains a frequent clinical challenge that may reduce treatment adherence, increase patient anxiety, and adversely affect wound healing outcomes2,
Access restricted. Please log in or start a trial to view this content.
This study was approved by the Ethics Committee of The Second People's Hospital of Liaocheng. Written informed consent was obtained from all participants before enrollment. The study was conducted at The Second People's Hospital of Liaocheng between December 2021 and October 2025. The reagents and the equipment used are listed in the Table of Materials.
Study subjects
Adult patients presenting with diabetic foot ulcers (DFUs) were screened according to the Practical Guidelines on the Prevention and Management of Diabetic Foot Ulcers. Participants were confirmed to be at least 18 years of age, ....
Access restricted. Please log in or start a trial to view this content.
Univariate analysis of pain-influencing factors
All 160 stage-1 patients and all 72 stage-2 patients were included in the respective analyses. No primary-outcome data were missing, and no imputation was performed. In the model-development cohort, the mean dressing-change VAS score among the 160 patients was 6.08 ± 2.40. Using the median value as the cutoff, patients were stratified into a high-pain group (VAS > 6, n = 64) and a low-pain group (VAS ≤ 6, n = 96). Univariate analysis revealed no stat.......
Access restricted. Please log in or start a trial to view this content.
This protocol describes the development, internal validation, and preliminary clinical evaluation of a linear regression model for predicting dressing-change pain in patients with diabetic foot ulcers (DFUs). By integrating routinely collected clinical variables with a risk-stratified analgesic care regimen, the protocol provides a standardized workflow for identifying patients who may experience greater dressing-change pain and implementing individualized pain-management strategies. Effective pain control during dressin.......
Access restricted. Please log in or start a trial to view this content.
The authors declare that there are no conflicts of interest regarding the publication of this study.
| Name | Company | Catalog Number | Comments |
|---|---|---|---|
| Digital Camera | Canon (China) Co., Ltd. (China) | EOS 850D | Used to capture high-definition wound images for ulcer area measurement using ImageJ software |
| Electronic Weight Scale | Omron Healthcare (China) Co., Ltd. (China) | HN-289 | Used to measure patients' weight for BMI calculation, which was included as a potential influencing factor |
| Flurbiprofen Axetil Injection | Beijing Tide Pharmaceutical Co., Ltd. (China) | 20220820 | Specification: 50mg/vial; additional intravenous administration when VAS ≥ 7 during dressing change in the high-risk group |
| Glycated Hemoglobin Analyzer | Roche Diagnostics Products (Shanghai) Co., Ltd. (China) | Cobas c513 | Used to detect patients' HbA1c levels, which were included in diabetes-related influencing factor analysis |
| Ibuprofen Sustained-Release Capsules | Fenbid Pharmaceutical Co., Ltd. (China) | 20220612 | Specification: 0.3g/capsule; used for oral analgesia in the moderate-risk group and control group, administered 30 minutes before dressing change |
| ImageJ Image Analysis Software | National Institutes of Health (NIH, USA) | 1.53k | Used for accurate measurement of wound area from captured images and calculation of ulcer area reduction rate |
| Intramuscular Injection Syringe | Jiangsu Changfeng Medical Technology Co., Ltd. (China) | 5ml/piece | Used for intramuscular injection of Tramadol Hydrochloride Injection in the control group when severe pain occurs |
| Intravenous Syringe | Shandong Weigao Group Medical Polymer Products Co., Ltd. (China) | 10ml/piece | Used for additional intravenous injection of Flurbiprofen Axetil Injection in the high-risk group |
| Medical Cotton Swabs | Sinocare Inc. (China) | 20221208 | Used for auxiliary wound cleaning and drug application to ensure sterile operation |
| Medical Stadiometer | Shanghai Rongshun Medical Technology Co., Ltd. (China) | RS-200 | Used to measure patients' height for BMI calculation |
| Normal Saline (0.9% Sodium Chloride Injection) | Sichuan Kelun Pharmaceutical Co., Ltd. (China) | 20221122 | Specification: 0.9%; used for wound irrigation and cleaning to remove necrotic tissue |
| Paracetamol and Oxycodone Hydrochloride Tablets | Pfizer Pharmaceuticals Ltd. (USA) | 20220715 | Composition: 325mg Paracetamol + 5mg Oxycodone/tablet; used for oral analgesia in the high-risk group, administered 30 minutes before dressing change |
| Paracetamol Tablets | Sino-US Tianjin SmithKline & French Pharmaceutical Co., Ltd. (China) | 20220506 | Specification: 0.5g/tablet; used for oral analgesia in the low-risk group, administered 30 minutes before dressing change |
| PASS Sample Size Calculation Software | NCSS LLC (USA) | 15 | Used to calculate sample size for model development and protocol validation phases based on primary outcome measure (VAS score) |
| Pressure Algometer | Beijing Jiehui Technology Co., Ltd. (China) | JHPT-100 | Used to measure patients' pain threshold and provide quantitative data for pain influencing factor analysis |
| Self-Designed Treatment Adherence Scale | self made (Cronbach’s α=0.86) | 20220220 | 0-100 point scale; used to evaluate patients' adherence to dressing change, medication, and intervention (≥80 points = complete adherence) |
| Self-Rating Anxiety Scale (SAS) | Standardized Psychological Assessment Scales (Chinese Association for Mental Health) | 20220215 | Used to assess patients' anxiety level; quantitative SAS scores were included as an influencing factor |
| Silver Ion Antibacterial Ointment | Hangzhou Yiqingchuang Biotechnology Co., Ltd. (China) | 20221016 | Used for antibacterial protection of wounds; applied to wounds before dressing in both groups |
| SPSS Statistical Software | IBM Corporation (USA) | 26 | Used for data entry and statistical analysis (t-test, ANOVA, logistic regression, etc.) |
| Sterile Gauze | Zhende Medical Products Co., Ltd. (China) | 20221105 | Used for wound covering and dressing; core consumable for dressing change |
| Sterile Gauze Pad | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (China) | 20221110 | Used for wrapping sterile ice packs to avoid direct skin contact during cold compress |
| Sterile Ice Pack | Qingdao Hainuo Biotechnology Co., Ltd. (China) | 20220418 | Used for local cold compress on wounds in the moderate-risk group; applied with sterile gauze wrapping to prevent skin frostbite |
| Tramadol Hydrochloride Injection | Grünenthal GmbH (Germany) | 20220910 | Specification: 100mg/vial; used as rescue analgesia via intramuscular injection in the control group when severe pain occurs |
| Visual Analog Scale (VAS) for Pain Assessment | Self-prepared (based on international standard templates) | 20220210 | 0-10 point scale; used for patients' subjective pain assessment during dressing change; recorded 3 consecutive times with average value taken |
Access restricted. Please log in or start a trial to view this content.