3D Printed vs Ready-to-Wear Insoles for Diabetic Neuropathy (3DP-DPN)
2026年6月14日 更新者：Anbreena Rasool、University of Faisalabad
Comparative Effect of 3D Printed Customized Insoles and Ready to Wear Insoles on Plantar Pressure Changes in Patients With Diabetic Neuropathy
Diabetic neuropathy is a condition caused by chronic high blood glucose levels that damage nerves over time, frequently causing abnormal plantar pressure and increasing the risk of foot ulcers and impaired mobility.
Insoles are widely used to redistribute pressure and improve comfort.
This study compares the effect of 3D printed customized insoles versus ready-to-wear insoles on plantar pressure changes in patients with diabetic neuropathy.
The study is a randomized controlled trial with 22 participants randomly allocated to two groups: one receiving 3D printed customized insoles and the other receiving ready-to-wear insoles.
Plantar pressure is measured using piezoresistive sensors and an Arduino Nano Unit.
Secondary outcomes include foot health status (FSHQ questionnaire), satisfaction with assistive technology (QUEST 2.0), and neuropathy severity (NSS and NDS questionnaires).
Assessments occur at baseline, 4 weeks, and 8 weeks.
調査の概要
詳細な説明
This is a single-blind, parallel-group randomized controlled trial conducted at DHQ-1 and DHQ-2 hospitals in Okara, Pakistan.
Participants are adults aged 35-65 years with diagnosed diabetic neuropathy who can walk independently without aids.
Exclusion criteria include foot ulcers, external wounds, recent surgery, major limb amputation, foot drop, peripheral vascular disease, neuromuscular diseases, and Charcot arthropathy.
A consecutive sampling technique is used to recruit 22 participants.
Randomization is performed using a computer-generated sequence.
Participants are blinded to their group allocation.
Group A receives 3D printed customized insoles tailored to individual foot morphology using 3D scanning and printing technology.
These insoles provide arch support and gait alignment.
Group B receives ready-to-wear insoles providing general cushioning and basic support.
Both groups follow an 8-week intervention protocol: participants wear insoles for a minimum of 6 hours per day, 5 days per week, and perform level walking on a 28-meter pathway at self-selected speed.
The protocol is divided into phases: weeks 1-2 for acclimatization and footwear assessment using Semmes-Weinstein 10g monofilament; weeks 3-4 for pressure adaptation and skin monitoring; weeks 5-6 for enhanced foot function and balance improvement; weeks 7-8 for final assessment.
Primary outcome: plantar pressure measured via piezoresistive sensors and Arduino Nano Unit.
Secondary outcomes: Foot Health Status Questionnaire (FSHQ), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0), Neuropathy Symptom Score (NSS), and Neuropathy Deficit Score (NDS).
Data are collected at baseline, week 4, and week 8. Statistical analysis uses SPSS version 22.
研究の種類
介入
入学 (推定)
22
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Punjab Province
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Faisalābad、Punjab Province、パキスタン、3800
- The University of Faisalabad
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 35 to 65 years
- Diagnosed with diabetes mellitus
- Clinical diagnosis of diabetic peripheral neuropathy
- Ability to walk independently without walking aids
- Normal cognitive function
- Corrected or uncorrected vision sufficient for safe ambulation
- Willingness to provide written informed consent
Exclusion Criteria:
- Presence of active foot ulcer
- External wound on lower extremity
- History of lower limb surgery within past 6 months
- Major lower limb amputation
- Foot drop
- Peripheral vascular disease
- Neuromuscular diseases (e.g., stroke, Parkinson's disease, multiple sclerosis)
- Charcot arthropathy
- Inability to comply with study protocol
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Group A: 3D Printed Customized Insoles
Participants in this group receive 3D printed customized insoles tailored to individual foot morphology.
Insoles are designed to provide arch support and gait alignment.
Participants wear insoles for minimum 6 hours/day, 5 days/week for 8 weeks, following a phased protocol of acclimatization, pressure adaptation, and function improvement.
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3D printed customized insoles are fabricated using 3D scanning of the participant's foot to capture individual morphology.
The insoles are printed using thermoplastic polyurethane (TPU) or similar 3D printing filament.
The intervention involves daily wear of insoles for minimum 6 hours per day, 5 days per week, for 8 weeks.
Participants perform level walking on a 28-meter pathway at self-selected speed.
Weekly assessments monitor adherence, skin condition, and comfort.
Patient education on foot care and insole use is provided.
Ready-to-wear insoles are prefabricated insoles providing general cushioning and shock absorption.
These insoles are not customized to individual foot morphology.
The intervention involves daily wear of insoles for minimum 6 hours per day, 5 days per week, for 8 weeks.
Participants perform level walking on a 28-meter pathway at self-selected speed.
Weekly assessments monitor adherence, skin condition, and comfort.
Patient education on foot care and insole use is provided.
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アクティブコンパレータ：Group B: Ready-to-Wear Insoles
Participants in this group receive prefabricated ready-to-wear insoles providing general cushioning and basic support.
Participants wear insoles for minimum 6 hours/day, 5 days/week for 8 weeks, following the same phased protocol as the experimental group.
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Ready-to-wear insoles are prefabricated insoles providing general cushioning and shock absorption.
These insoles are not customized to individual foot morphology.
The intervention involves daily wear of insoles for minimum 6 hours per day, 5 days per week, for 8 weeks.
Participants perform level walking on a 28-meter pathway at self-selected speed.
Weekly assessments monitor adherence, skin condition, and comfort.
Patient education on foot care and insole use is provided.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Plantar Pressure Distribution
時間枠：Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
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Plantar pressure is measured using piezoresistive sensors connected to an Arduino Nano Unit.
Participants walk barefoot across the sensor platform.
The sensor records pressure distribution across the plantar surface in kilopascals (kPa).
Higher pressure values indicate greater plantar load, which is associated with increased risk of foot ulceration.
Lower pressure values indicate better offloading.
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Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Foot Health Status Questionnaire (FSHQ) Score
時間枠：Baseline (Week 0), Week 4, Week 8
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The Foot Health Status Questionnaire (FSHQ) is a validated instrument assessing foot-related quality of life.
It includes domains of foot pain, foot function, footwear, and general foot health.
Each item is scored on a Likert scale.
Minimum score is zero and maximum score is 100.
scores are generally classified into ranges such as Very Low: 0-24.9
Low:25-49.9
Medium: 50-74.9
High: 75-100 HIgher score indicates better foot health and lower score indicates worst foot health.
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Baseline (Week 0), Week 4, Week 8
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月1日
一次修了 (推定)
2026年6月30日
研究の完了 (推定)
2026年7月15日
試験登録日
最初に提出
2026年6月6日
QC基準を満たした最初の提出物
2026年6月6日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月14日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- TUF/EIRB/ 195 /26
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
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いいえ
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