EmoLED医疗器械治疗2期和3期压疮疗效的随机临床试验：RISE_UP研究

IF 2.4 3区医学 Q2 DERMATOLOGY

Journal of tissue viability Pub Date : 2025-03-26 DOI:10.1016/j.jtv.2025.100895

Hamilton Dollaku , Mara Dalladonna , Marika Giuliano , Michele Rossi , Paola Barbetti , Maria Sipontina Marcolongo , Emanuele Buccione , Paolo Iovino , Claudio Macchi

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引用次数: 0

摘要

研究目的压疮是一个重要的公共卫生问题，影响生活质量并导致健康恶化。蓝光光生物调节已被证明可促进血管、糖尿病、风湿病溃疡和脊髓损伤患者的伤口愈合。基于这些初步结果，本研究旨在评估蓝光治疗二期和三期压疮的有效性。材料和方法本研究是一项随机对照试验，纳入了活动能力差的住院患者。干预组在标准治疗的基础上进行蓝光治疗，每周三次，连续4周。主要目的是通过测量第一次和最后一次访问之间病变PUSH评分的平均差异来衡量愈合过程的差异。结果分析显示，治疗组的平均PUSH降低率和属于应答患者的概率较高。根据治疗反应确定两种轨迹类别的潜在剖面分析显示，治疗组遵循最佳轨迹的概率存在关联（30% vs 2%）。结论蓝光光生物调节可促进压疮组织修复的恢复，并可稳定经标准护理治疗后仍会恶化的创面。这种疗法可能对压力性病变的日常管理有价值，因为它具有良好的安全性，并且在治疗方案中加入这种疗法可能会加速愈合，提高生活质量。: NCT05130814)

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Randomized clinical trial of the efficacy of the EmoLED medical device in the treatment of stage 2 and stage 3 pressure ulcers: The RISE_UP study

Aim of the study

Pressure ulcers are an important public health issue, impacting quality of life and causing health deterioration. Blue light photobiomodulation has been shown promoting wound healing in vascular, diabetic, rheumatologic ulcers and lesions in spinal cord injury patients. Based on these preliminary results, this study was developed to assess the effectiveness of blue light therapy in second and third stage pressure ulcers.

Materials and methods

This study was a randomized controlled trial enrolling hospitalized patients with poor mobility. The intervention group included blue light treatment in addition to standard care, three times a week, for 4 consecutive weeks. The primary objective is the difference in the healing process by measuring the average difference of the lesion's PUSH score between the first and the last visit.

Results

The analysis shows that the mean PUSH reduction and the probability of belonging to responder patients were higher in the treatment group. A latent profile analysis that identifies two trajectory classes based on treatment response, shows an association in the probability of following best trajectory for the treatment group (30 % vs 2 %).

Conclusions

The result shows that blue light photobiomodulation promotes recovery of tissue repair in pressure ulcers, and in stabilizing wounds that would otherwise worsen despite standard of care treatment. This therapy may be a valuable contribution to the daily management of pressure lesions since it has an excellent safety profile and the addition of this therapy to a treatment program may speed healing, improving the quality of life.

(Clinicaltrials.gov Ref. numb.: NCT05130814)

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来源期刊

Journal of tissue viability DERMATOLOGY-NURSING

CiteScore

3.80

自引率

16.00%

发文量

110

审稿时长

>12 weeks

期刊介绍： The Journal of Tissue Viability is the official publication of the Tissue Viability Society and is a quarterly journal concerned with all aspects of the occurrence and treatment of wounds, ulcers and pressure sores including patient care, pain, nutrition, wound healing, research, prevention, mobility, social problems and management. The Journal particularly encourages papers covering skin and skin wounds but will consider articles that discuss injury in any tissue. Articles that stress the multi-professional nature of tissue viability are especially welcome. We seek to encourage new authors as well as well-established contributors to the field - one aim of the journal is to enable all participants in tissue viability to share information with colleagues.