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治験 NCT07452354（対象：糖尿病足潰瘍（DFU）、糖尿病、Diabetic Foot Ulcer Treatment、Artificial Intelligence (AI) in Diagnosis）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
AI-Based Diabetic Foot Recurrence Cohort 200 在宅 予防
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07452354 は 観察研究 臨床試験 で、糖尿病足潰瘍（DFU）、糖尿病、Diabetic Foot Ulcer Treatment、Artificial Intelligence (AI) in Diagnosis に関するものです。現在は 募集準備中 で、2026年3月15日 に開始予定です。200 名の参加者 の募集が計画されています。この試験は Peking University Third Hospital によって主導され、2028年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月5日 です。
概要
Diabetic foot ulcer (DFU) is a major adverse outcome of diabetes, which itself is one of the most significant chronic diseases. The recurrence of DFU involves multiple risk factors, including altered foot loading patterns, patient compliance, family care capacity, blood glucose monitoring, degree of ischemia, and systemic disease control. Early identification of recurrence signs and timely follow-up interventions are...もっと見る
公式タイトル
Development and Validation of an AI-Based Wound Alert System With a Home-Based Management Model for a Diabetic Foot Recurrence Cohort
疾患名
糖尿病足潰瘍（DFU）糖尿病Diabetic Foot Ulcer TreatmentArtificial Intelligence (AI) in Diagnosis刊行物
この臨床試験について発表された科学記事と研究論文：- [1] Li Y, Teng D, Shi X, et al. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross-sectional study. BMJ. 2020 Apr 28;369:m997. [2] Edmonds M. A renaissance in diabetic foot care: new evidence-based treatments. Lancet Diabetes Endocrinol. 2018;6(11):837-838. [3] Hingorani A, LaMuraglia GM, Henke P...
その他の研究識別子
- Long2026-DFU-Reccurren Cohort
NCT番号
開始日
2026-03-15
最終更新日
2026-03-05
終了予定日
2028-12-31
目標参加者数
200
試験の種類
観察研究
状況
募集準備中
キーワード
Diabetic Foot Ulcer
Diabetic Foot Ulcer Treatment
Diabete Mellitus
Reccurrence
Artificial Intelligence (AI) in Diagnosis
Diabetic Foot Ulcer Treatment
Diabete Mellitus
Reccurrence
Artificial Intelligence (AI) in Diagnosis
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
DFU Healed The wound etiology was diabetic foot. Post-treatment clinical assessment confirmed complete wound healing, characterized by epithelialization of the wound bed and margins, absence of exudation, no evidence of periwound erythema or edema, and the restoration of adequate tensile strength to withstand physiological stress without dehiscence. | Researchers predefined groups based on risk stratification to formulate personalized follow-up strategies. Management strategies encompass follow-up frequency, AI-assisted foot self-examination, AI-powered glucose monitoring, offloading device utilization, daily step count restriction, patient health education, and compliance assessment. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
One-year recurrence rate of diabetic foot | The recurrence rate of diabetic foot ulcers (%) = (The number of diabetic foot ulcer patients with recurrence within one year / The total number of diabetic foot ulcer patients included in the observation and whose ulcers have healed) × 100% | one year |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
The number of diabetic foot recurrences within one year | The number of diabetic foot recurrences within one year | one year |
Recurrence time | The time from wound healing to the first DFU recurrence | one year |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- The patient must be aged 18 years or older; have a confirmed diagnosis of type 1 or type 2 diabetes mellitus according to the World Health Organization criteria; the wound etiology attributable to diabetic foot ulcers, with complete wound healing post-treatment defined as a dry wound devoid of exudate, complete epithelialization of both the wound bed and margins, absence of surrounding erythema or edema, and sufficient tensile strength to withstand pressure without dehiscence; voluntary participation in this study with provision of written informed consent.
- Inability of the patient to cooperate or presence of psychiatric disorders; At the investigator's discretion, the subject is deemed unsuitable for this study or unable to comply with the study requirements.
Peking University Third Hospital責任者
Long Zhang, 主任研究者, Head of Wound Healing Center, Peking University Third Hospital
試験中央連絡先
連絡先: Long Zhang Executive Deputy Director, Medical Doctor, +86 010-82266699, [email protected]
1 1カ国の場所
Beijing Municipality
Peking University Third Hospital, Beijing, Beijing Municipality, 100191, China
Yunfeng Li, Medical Doctor, 連絡先, +86 010-82267791, [email protected]