Apr 27, 2026
Application of offloading interventions in patients with high-risk diabetic foot: a scoping review
- lingqi gu1
- 1Kunming Medical University School of Nursing
Protocol Citation: lingqi gu 2026. Application of offloading interventions in patients with high-risk diabetic foot: a scoping review . protocols.io https://dx.doi.org/10.17504/protocols.io.yxmvm6986l3p/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Other
We attempted this protocol but could not get it to work in our workspace
Created: March 07, 2026
Last Modified: April 27, 2026
Protocol Integer ID: 281636
Keywords: risk diabetic foot, diabetic foot, offloading intervention, risk foot in china, interventions in patient, patient adherence, reference for the clinical care, scoping review, risk foot, application of offloading device, offloading device
Disclaimer
This study is a retrospective observational study based on pre-existing medical records or data, and does not involve any new interventions, treatments, or direct contact with subjects. This protocol and its related findings are intended to provide reference for clinical practice or to generate hypotheses for further prospective research, and are not intended as medical advice or a basis for diagnosis or treatment for any specific patient. The authors declare no conflicts of interest.
Abstract
Objective
To conduct a scoping review on the application status of offloading interventions in patients with diabetic high-risk foot both domestically and internationally, and to systematically summarize the types of offloading devices, their application effects, and patient adherence, thereby providing a reference for the clinical care of patients with diabetic high-risk foot in China.
Methods
Guided by the JBI methodology for scoping reviews, a systematic search was conducted in databases including Web of Science, PubMed, Embase, Science Direct, CNKI, Wanfang, and VIP for studies related to the application of offloading devices in patients with diabetic high-risk foot. The search period covered from the inception of each database to December 2025. Two researchers independently performed literature screening and data extraction.
Guidelines
Search Strategy
A computerized systematic search was conducted in seven databases: Web of Science, PubMed, Embase, Science Direct, CNKI, Wanfang Data, and VIP. The search period was from the inception of each database to December 2025. The research topics were identified as "offloading intervention" and "diabetic high-risk foot".
Taking the pubmed search strategy as an example:
#1 "Diabetic Angiopathies"[Mesh] OR "Diabetic Angiopathy"[Title/Abstract] OR "Diabetic Vascular Diseases"[Title/Abstract] OR "Peripheral Arterial Disease"[Mesh] OR "Lower Limb Ischemia"[Title/Abstract]
#2 "Diabetic Neuropathies"[Mesh] OR "Diabetic Neuropathy"[Title/Abstract] OR "Diabetic Peripheral Neuropathy"[Title/Abstract]
#3 "Foot"[Mesh] OR "Foot Deformities"[Mesh] OR "Biomechanical Phenomena"[Mesh] OR "Gait"[Mesh] OR "Plantar Pressure"[Title/Abstract] OR "Foot Deformities"[Title/Abstract] OR "Charcot Foot"[Title/Abstract] OR "Hammer Toe"[Title/Abstract] OR "Hallux Valgus"[Title/Abstract] OR "Hindfoot"[Title/Abstract] OR "Midfoot"[Title/Abstract] OR "Forefoot"[Title/Abstract] OR "Metatarsal Head"[Title/Abstract] OR "Phalanges"[Title/Abstract] OR "Calcaneus"[Title/Abstract]
#4 "Diabetic Foot"[Mesh] OR "Foot Ulcer"[Mesh] OR "High-Risk Foot"[Title/Abstract] OR "Pre-Ulcerative Foot"[Title/Abstract]
#5 "Shoes"[Mesh] OR "Orthotic Devices"[Mesh] OR "Offloading Shoes"[Title/Abstract] OR "footwear"[Title/Abstract] OR "Removable cast walker"[Title/Abstract] OR "Total contact cast"[Title/Abstract] OR "cushioned insole"[Title/Abstract] OR "rigid rocker"[Title/Abstract] OR "pressure relief"[Title/Abstract] OR "Prescription footwear"[Title/Abstract]
#6 (#1 OR #2 OR #3) AND #4 AND #5
Taking the cnki search strategy as an example:
#1 “糖尿病高危足” OR “溃疡前糖尿病足” “糖尿病血管病变” OR “糖尿病血管并发症” OR “糖尿病大血管病变” OR “糖尿病微血管病变” OR “糖尿病性周围血管病变” OR “下肢缺血” OR “糖尿病动脉疾病”
#2 “糖尿病神经病变” OR “糖尿病神经并发症” OR “糖尿病性周围神经病变” OR “糖尿病性感觉神经病变” OR “糖尿病性自主神经病变” OR “足底压力” OR “机械应力” OR “足部生物力学” OR “足部形” OR “夏科足” OR “锤状趾” OR “爪形趾” OR “拇外翻” OR “跖骨头突出” OR “峰值压力” OR “截肢” OR “生物力学”
#3 “减压鞋” OR “半鞋” OR “处方鞋” OR “硬性摇底” OR “缓冲鞋垫” OR “硬摇杆鞋” OR “全长鞋” OR “全接触鞋垫” OR “预制矫形鞋垫” OR “横制鞋垫” OR “村垫” OR “气垫” OR “羊毛垫” OR “凹点鞋垫” OR “鞋类合脚度” OR “骨科鞋”
#4 “矫形器” OR “足弓杯” OR “内侧足弓形状” OR “可拆卸矫形器” OR “踝足矫形器” OR “全接触石膏”
#5 (#1 OR #2 OR #3) AND #4 AND #5
1.4 Literature Screening and Data Extraction
Literature screening was independently conducted by two researchers who had received evidence-based training and passed relevant assessments. Based on the inclusion and exclusion criteria, screening was performed using Zotero 7.0 reference management software. In case of disagreements, a discussion with a third reviewer was held to decide on inclusion. The data extracted from the literature included author(s), country, year of publication, study population, sample size, type of offloading intervention, intervention duration, and outcome measures.
Materials
1 Materials and Methods
1.1 Identifying the Research Questions
Using the JBI methodology for scoping reviews as the methodological framework, the review questions included: What are the types and indications for the application of offloading devices in the care of patients with diabetic foot? What are the evaluation criteria and effects of their application?
1.2 Inclusion and Exclusion Criteria
Inclusion and exclusion criteria were determined according to the PCC principle: ① Population (P): Patients with a diabetic high-risk foot who meet the indications for using offloading devices; ② Concept (C): Offloading devices; ③ Context (C): The use of offloading devices to prevent the progression of a diabetic high-risk foot or the recurrence of foot ulcers; ④ Study designs included randomized controlled trials, quasi-experimental studies, cohort studies, and case-control studies. Exclusion criteria were: ① Non-Chinese or non-English articles; ② Publication types such as study protocols, guidelines, reviews, opinions, conference abstracts, or proposals; ③ Full text not available.
Materials and Methods
Identifying the Research Questions
Using the JBI methodology for scoping reviews as the methodological framework, the review questions included: What are the types and indications for the application of offloading devices in the care of patients with diabetic foot? What are the evaluation criteria and effects of their application?
Inclusion and Exclusion Criteria
Inclusion and exclusion criteria were determined according to the PCC principle: ① Population (P): Patients with a diabetic high-risk foot who meet the indications for using offloading devices; ② Concept (C): Offloading devices; ③ Context (C): The use of offloading devices to prevent the progression of a diabetic high-risk foot or the recurrence of foot ulcers; ④ Study designs included randomized controlled trials, quasi-experimental studies, cohort studies, and case-control studies. Exclusion criteria were: ① Non-Chinese or non-English articles; ② Publication types such as study protocols, guidelines, reviews, opinions, conference abstracts, or proposals; ③ Full text not available.
Search Strategy
A computerized systematic search was conducted in seven databases: Web of Science, PubMed, Embase, Science Direct, CNKI, Wanfang Data, and VIP. The search period was from the inception of each database to December 2025. The research topics were identified as "offloading intervention" and "diabetic high-risk foot".
Taking the pubmed search strategy as an example:
#1 "Diabetic Angiopathies"[Mesh] OR "Diabetic Angiopathy"[Title/Abstract] OR "Diabetic Vascular Diseases"[Title/Abstract] OR "Peripheral Arterial Disease"[Mesh] OR "Lower Limb Ischemia"[Title/Abstract]
#2 "Diabetic Neuropathies"[Mesh] OR "Diabetic Neuropathy"[Title/Abstract] OR "Diabetic Peripheral Neuropathy"[Title/Abstract]
#3 "Foot"[Mesh] OR "Foot Deformities"[Mesh] OR "Biomechanical Phenomena"[Mesh] OR "Gait"[Mesh] OR "Plantar Pressure"[Title/Abstract] OR "Foot Deformities"[Title/Abstract] OR "Charcot Foot"[Title/Abstract] OR "Hammer Toe"[Title/Abstract] OR "Hallux Valgus"[Title/Abstract] OR "Hindfoot"[Title/Abstract] OR "Midfoot"[Title/Abstract] OR "Forefoot"[Title/Abstract] OR "Metatarsal Head"[Title/Abstract] OR "Phalanges"[Title/Abstract] OR "Calcaneus"[Title/Abstract]
#4 "Diabetic Foot"[Mesh] OR "Foot Ulcer"[Mesh] OR "High-Risk Foot"[Title/Abstract] OR "Pre-Ulcerative Foot"[Title/Abstract]
#5 "Shoes"[Mesh] OR "Orthotic Devices"[Mesh] OR "Offloading Shoes"[Title/Abstract] OR "footwear"[Title/Abstract] OR "Removable cast walker"[Title/Abstract] OR "Total contact cast"[Title/Abstract] OR "cushioned insole"[Title/Abstract] OR "rigid rocker"[Title/Abstract] OR "pressure relief"[Title/Abstract] OR "Prescription footwear"[Title/Abstract]
#6 (#1 OR #2 OR #3) AND #4 AND #5
Taking the cnki search strategy as an example:
#1“糖尿病高危足” OR “溃疡前糖尿病足”
#2 “糖尿病血管病变” OR “糖尿病血管并发症” OR “糖尿病大血管病变” OR “糖尿病微血管病变” OR “糖尿病性周围血管病变” OR “下肢缺血” OR “糖尿病动脉疾病”
#3 “糖尿病神经病变” OR “糖尿病神经并发症” OR “糖尿病性周围神经病变” OR “糖尿病性感觉神经病变” OR “糖尿病性自主神经病变”
#4 “足底压力” OR “机械应力” OR “足部生物力学” OR “足畸形” OR “夏科足” OR “锤状趾” OR “爪形趾” OR “拇外翻” OR “跖骨头突起” OR “峰值压力” OR “截肢” OR “生物力学”
#5“减压鞋” OR “半鞋” OR “处方鞋” OR “硬性摇底” OR “缓冲鞋垫” OR “硬摇杆鞋” OR “全长鞋” OR “全接触鞋垫” OR “预制矫形鞋垫” OR “模制鞋垫” OR “衬垫” OR “气垫” OR “羊毛毡” OR “凹点鞋垫” OR “鞋类合脚度” OR “骨科鞋”
#6 (#2 OR #3 OR #4) AND #1 AND #5
Literature Screening and Data Extraction
Literature screening was independently conducted by two researchers who had received evidence-based training and passed relevant assessments. Based on the inclusion and exclusion criteria, screening was performed using Zotero 7.0 reference management software. In case of disagreements, a discussion with a third reviewer was held to decide on inclusion. The data extracted from the literature included author(s), country, year of publication, study population, sample size, type of offloading intervention, intervention duration, and outcome measures.