慢性病防治专栏

门诊应用负压微引流联合超声清创治疗糖尿病足溃疡的疗效

  • 相佳宁 ,
  • 钟华 ,
  • 任嘉毅 ,
  • 刘珂如 ,
  • 李文睿 ,
  • 曹志斌
展开
  • 1.山东第二医科大学临床医学院 (山东 潍坊 261041 )
    2.山东第二医科大学附属医院内分泌代谢病科 (山东 潍坊 261031 )

收稿日期: 2025-11-03

  网络出版日期: 2026-03-09

基金资助

山东省中医药科技项目(NM-2022238);潍坊市卫生健康委员会中医药科研项目(编号:2022 年第3类-003号)

Efficacy of negative pressure wound therapy combined with ultrasound debridement for diabetic foot ulcers in the outpatient setting

  • Jianing XIANG ,
  • Hua ZHONG ,
  • Jiayi REN ,
  • Keru LIU ,
  • Wenrui LI ,
  • Zhibin CAO
Expand
  • 1.School of Clinical Medicine,Shandong Second Medical University,Weifang 261041,Shandong,China
    2.Department of Endocrinology and Metabolism,the Affiliated Hospital of Shandong Second Medical University,Weifang 261031,Shandong,China

Received date: 2025-11-03

  Online published: 2026-03-09

摘要

目的 探讨在门诊场景下应用一次性负压微引流护创材料(single-use negative pressure wound therapy, sNPWT)联合超声清创术(ultrasound debridement, UD)治疗糖尿病足溃疡(diabetic foot ulcers, DUF)的疗效。 方法 选择2024年6月1日至2025年6月30日山东第二医科大学附属医院内分泌代谢病科门诊收治的糖尿病足患者60例,根据治疗方案不同分为常规治疗组(对照组1)、单一一次性负压微引流护创材料治疗组(对照组2)、联合治疗组(观察组),每组20例。在常规降糖和抗感染治疗基础上,对照组1给予传统外科清创加常规换药治疗;对照组2给予传统外科清创加一次性负压微引流护创材料治疗;联合治疗组给予UD联合一次性负压微引流护创材料治疗。比较3组患者治疗1、2、4周后的主要疗效指标(糖尿病足溃疡创面缩小率、窦道深度变化情况及溃疡愈合率)及次要指标(疼痛评分、生活质量及C反应蛋白水平的表达)。 结果 主要疗效指标:治疗4周后,观察组的创面缩小率(69.16 ± 2.33)%显著高于对照组1的(53.33 ± 2.27)%与对照组2的(58.47 ± 2.15)%,差异有统计学意义(P < 0.05)。观察组的窦道深度降至(0.47 ± 0.19) cm,显著浅于对照组1的(0.88 ± 0.40)cm和对照组2的(0.69 ± 0.32)cm,差异有统计学意义(P < 0.05)。观察组与对照组2的临床总有效率均达95.0%,显著高于对照组1的65.0%,差异有统计学意义(P < 0.05)。次要疗效指标:在患者报告结局方面,观察组的VAS疼痛评分2.05分与Wound-QoL生活质量评分26.65分均为3组中最低值(均P < 0.05),且其生活质量的改善自第2周起即显著优于对照组2(P < 0.05)。在炎症指标方面,观察组4周后的C反应蛋白水平(2.45 ± 0.36) mg/L,显著低于对照组1的(2.86 ± 0.51)mg/L,差异有统计学意义(P < 0.05)。 结论 作为门诊糖尿病足治疗的首次联合应用,一次性负压微引流护创材料联合UD治疗糖尿病足溃疡可促进创面愈合,减轻患者疼痛程度,提高患者生活质量以及抑制炎性因子。

本文引用格式

相佳宁 , 钟华 , 任嘉毅 , 刘珂如 , 李文睿 , 曹志斌 . 门诊应用负压微引流联合超声清创治疗糖尿病足溃疡的疗效[J]. 实用医学杂志, 2026 , 42(5) : 824 -830 . DOI: 10.3969/j.issn.1006-5725.2026.05.013

Abstract

Objective To evaluate the efficacy of combining single-use negative pressure wound therapy (sNPWT) with ultrasound debridement (UD) for the treatment of diabetic foot ulcers (DFU) in an outpatient setting. Methods Sixty diabetic foot patients admitted to the Endocrinology and Metabolic Diseases Department of Shandong Second Medical University Affiliated Hospital between June 1, 2024, and June 30, 2025, were enrolled. Based on the actual treatment recorded in their medical records, they were divided into three groups (n = 20): conventional therapy group (control group 1), sNPWT group (control group 2), and combined UD + sNPWT group (experimental group). All patients received standard hypoglycemic and anti-infective therapy. Control group 1 received traditional surgical debridement with routine dressing changes. Control group 2 received traditional surgical debridement plus sNPWT. The experimental group received UD combined with sNPWT. The primary efficacy endpoints (wound area reduction rate, change in sinus tract depth, ulcer healing rate) and secondary endpoints (pain score, quality of life, C-reactive protein levels) were assessed among the three groups at 1, 2, and 4 weeks after treatment initiation. Results Primary efficacy endpoints: After 4 weeks, the wound reduction rate in the experimental group (69.16 ± 2.33) % was significantly higher than that in control group 1 (53.33 ± 2.27) % and control group 2 (58.47 ± 2.15) % (P < 0.05). The sinus tract depth in the experimental group decreased to (0.47 ± 0.19) cm, significantly shallower than that in control group 1 [(0.88 ± 0.40) cm] and control group 2 [(0.69 ± 0.32) cm] (P < 0.05). The overall clinical efficacy rate was 95.0% in both the experimental group and control group 2, significantly higher than the 65.0% in control group 1 (P < 0.05). Secondary endpoints: The experimental group exhibited the lowest VAS pain score (2.05 points) and Wound-QoL score (26.65 points) among all groups (both P < 0.05). Quality of life improvements were significantly greater than in control group 2 from week 2 onward (P < 0.05). The C-reactive protein level in the experimental group [(2.45 ± 0.36) mg/L] at 4 weeks was significantly lower than that in control group 1 [(2.86 ± 0.51) mg/L] (P < 0.05). Conclusion The combination of sNPWT and UD, applied for the first time in an outpatient setting for diabetic foot treatment, promotes wound healing, reduces pain, improves quality of life, and suppresses inflammatory factors in patients with DFU.

参考文献

[1] ARMSTRONG D G, TAN T W, BOULTON A J M, et al. Diabetic Foot Ulcers: A Review[J]. JAMA, 2023, 330(1): 62-75. doi:10.1001/jama.2023.10578 .
[2] REHMAN Z U, KHAN J, NOORDIN S. Diabetic Foot Ulcers: Contemporary Assessment And Management[J]. J Pakistan Med Assoc, 2023, 73(7): 1480-1487. doi:10.47391/JPMA.6634 .
[3] LIU E, HU X, ZHANG W, et al. Efficacy and safety of ultrasound-assisted wound debridement in the treatment of diabetic foot ulcers: A systematic review and meta-analysis of 11 randomized controlled trials[J]. Front Endocrinol, 2024, 15: 1393251. doi:10.3389/fendo.2024.1393251 .
[4] CHEN L, ZHANG S, DA J, et al. A systematic review and meta-analysis of efficacy and safety of negative pressure wound therapy in the treatment of diabetic foot ulcer[J]. Annal Palliat Med, 2021, 10(10): 108300839-108310839. doi:10.21037/apm-21-2476 .
[5] DALMEDICO M M, ROCIO FEDALTO A DO, MARTINS W A, et al. Effectiveness of negative pressure wound therapy in treating diabetic foot ulcers: A systematic review and meta-analysis of randomized controlled trials[J]. Wounds, 2024, 36(8): 281-289. doi:10.25270/wnds/23140 .
[6] KIRSNER R S, ZIMNITSKY D, ROBINSON M. A prospective, randomized, controlled clinical study on the effectiveness of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of diabetic ulcers of the lower extremities[J]. Wound Repair Regen, 2021, 29(6): 908-911. doi:10.1111/wrr.12966 .
[7] SCHAPER N C, VAN NETTEN J J, APELQVIST J, et al. Practical guidelines on the prevention and management of diabetes-related foot disease (IWGDF 2023 update)[J]. Diabetes Metab Res Rev, 2024, 40(3): e3657. doi:10.1002/dmrr.3657 .
[8] WAGNER F W. The dysvascular foot: A system for diagnosis and treatment[J]. Foot Ankle, 1981, 2(2): 64-122. doi:10.1177/107110078100200202 .
[9] 吴倩. 慢性伤口患者生活质量量表(Wound-QoL)汉化及信效度检验[D]. 南宁:广西中医药大学, 2022.
[10] SENNEVILLE é, ALBALAWI Z, VAN ASTEN S A, et al. IWGDF/IDSA guidelines on the diagnosis and treatment of diabetes-related foot infections (IWGDF/IDSA 2023)[J]. Diabetes Metab Res Rev, 2024, 40(3): e3687. doi:10.1002/dmrr.3687 .
[11] DAYYA D, O’NEILL O J, HUEDO-MEDINA T B, et al. Debridement of Diabetic Foot Ulcers[J]. Adv Wound Care, 2022, 11(12): 666-686. doi:10.1089/wound.2021.0016 .
[12] KATAOKA Y, KUNIMITSU M, NAKAGAMI G, et al. Effectiveness of ultrasonic debridement on reduction of bacteria and biofilm in patients with chronic wounds: A scoping review[J]. Int Wound J, 2021, 18(2): 176-186. doi:10.1111/iwj.13509 .
[13] ZAVER V, KANKANALU P. Negative Pressure Wound Therapy[M].StatPearls. Treasure Island (FL): StatPearls Publishing, 2025.
[14] WANG T, FAN L, LIU J, et al. Negative Pressure Wound Therapy Promotes Wound Healing by Inhibiting Inflammation in Diabetic Foot Wounds: A Role for NOD1 Receptor[J]. Int J Lower Extrem Wound, 2025, 24(4): 994-1002. doi:10.1177/15347346221131844 .
[15] FLORES-ESCOBAR S, áLVARO-AFONSO F J, GARCíA-áLVAREZ Y, et al. Ultrasound-Assisted Wound (UAW) Debridement in the Treatment of Diabetic Foot Ulcer: A Systematic Review and Meta-Analysis[J]. J Clin Med, 2022, 11(7): 1911. doi:10.3390/jcm11071911 .
[16] YANG R, CHEN G, PAN Q Y, et al. Evaluating the effectiveness of ultrasound-assisted wound debridement in managing diabetic foot ulcers: A systematic review and meta-analysis[J]. World J Diabete, 2025, 16(2): 97077. doi:10.4239/wjd.v16.i2.97077 .
[17] ANGULO A R, CABALLERO-ALVARADO J, SARMIENTO-FALEN J, et al. Comparative Assessment of Negative Pressure Wound Therapy Versus Standard Treatment in Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis[J]. J Wound Ostomy Continence Nurs, 2025, 52(3): 227-238. doi:10.1097/WON.0000000000001164 .
[18] OUYANG H, YANG J, WAN H, et al. Effects of different treatment measures on the efficacy of diabetic foot ulcers: A network meta-analysis[J]. Front Endocrinol, 2024, 15: 1452192. doi:10.3389/fendo.2024.1452192 .
[19] 陈存仁, 方团育, 莫泽纬, 等. 封闭负压引流联合微动力负压敷料促进糖尿病足创面愈合的效果[J]. 实用医学杂志, 2021, 37(9): 1164-1167. doi: 10.3969/j.issn.1006-5725. 2021. 09.014 .
[20] 张晓磊. 超声清创刀联合简易负压治疗糖尿病足溃疡的临床效果观察[C].梅州:关爱生命大讲堂之生命关怀与智慧康养系列学术研讨会论文集(上)--临床心理关怀与医院人文建设的融合专题. 线上会议, 2025: 3, 124-126.
[21] 李旭文, 宋培军, 熊竹友, 等. 超声清创水刀联合封闭负压引流技术在糖尿病足溃疡中的应用[J]. 蚌埠医学院学报, 2022, 47(8): 1007-1010. doi:10.13898/j.cnki.issn.1000-2200. 2022.08.005 .
[22] 罗富强, 余电柏, 谢康麒, 等. 糖尿病足溃疡创面修复相关机制的研究进展[J]. 实用医学杂志, 2023, 39(2): 158-163.doi: 10.3969/j.issn.1006-5725.2023.02.006 .
[23] HUANG Y, YU Z, XU M, et al. Negative pressure wound therapy promotes wound healing by down-regulating miR-155 expression in granulation tissue of diabetic foot ulcers[J]. Sci Rep, 2025, 15: 6733. doi:10.1038/s41598-025-90643-7 .
[24] DAWI J, TUMANYAN K, TOMAS K, et al. Diabetic Foot Ulcers: Pathophysiology, Immune Dysregulation, and Emerging Therapeutic Strategies[J]. Biomed, 2025, 13(5): 1076. doi:10.3390/biomedicines13051076 .
[25] WANG P, LI Z P, RUAN Y H, et al. Optimization and advances in negative pressure wound therapy for the management of necrotizing fasciitis in the upper limb[J]. World J Orthop, 2025, 16(3): 105130. doi:10.5312/wjo.v16.i3.105130 .
[26] ALKHALEFAH S, ALTURAIKI I, ALTWAIJRY N. Advancing Diabetic Foot Ulcer Care: AI and Generative AI Approaches for Classification, Prediction, Segmentation, and Detection[J]. Healthcare, 2025, 13(6): 648. doi:10.3390/healthcare13060648 .
[27] Chinese Burn Association, The Yangtze River Delta Integrated Diabetic Foot Alliance, And The Editorial Committee Of The Chinese Journal Of Burns And Wound Repair, LUO G, LIU Y, et al. Practical guidelines for the prevention and management of diabetic foot disease in China[J]. Burns Trauma, 2025, 13: tkaf064. doi:10.1093/burnst/tkaf064 .
文章导航

/