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治験 NCT07147790 (SNIPS-FOOT)(対象:Ischemia Limb、糖尿病)は招待限定です。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
Comparative Study of Negative-Pressure Wound Therapy Integrated With Silver Nanoparticle Spray Versus Negative-Pressure Wound Therapy in Post-Revascularization Diabetic Foot Wound Management (SNIPS-FOOT) 100 無作為化
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 NCT07147790 (SNIPS-FOOT) は 観察研究 臨床試験 で、Ischemia Limb、糖尿病 に関するものです。現在は 招待限定 で、2024年5月5日 から開始しています。100 名の参加者 の募集が計画されています。この試験は カフル・エルシェイク大学 によって主導され、2025年12月10日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月11日 です。
概要
This was a prospective, parallel-group, randomized controlled trial conducted at the Vascular Surgery Department of Kafrelsheikh University Hospital, Egypt. The study was approved by the Institutional Review Board and conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Patients were eligible if they were ≥18 years of age, had diabetes mellitus with c...
もっと見る公式タイトル
Comparative Study of Negative-Pressure Wound Therapy Integrated With Silver Nanoparticle Spray Versus Negative-Pressure Wound Therapy in Post-Revascularization Diabetic Foot Wound Management
疾患名
Ischemia Limb糖尿病その他の研究識別子
- SNIPS-FOOT
- KFSIRB200-252
- [email protected] (その他の識別子) (kafrelsheikh university)
群(アーム)/介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
two groups A and B groups A total of 100 patients were randomized into two equal groups using a computer-generated list with sealed opaque envelopes. Twelve patients were excluded post-randomization, resulting in 88 patients (44 per group) for final analysis.
Group A received NPWT integrated with silver nanoparticle spray applied for 15 minutes before NPWT application using foam pre-soaked with the same spray. Group B received standard NPWT ...もっと見る | After successful revacularization, We will categorize patients into two groups : groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the woun After successful revacularization, We will categorize patients into two groups :
groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the wound with silver nanoparticle spray for 15 minutes (time needed for its absorption) before applying NPWT with foam soaked in silver nanoparticle spray) and group B (The patient's wounds will be cleaned and irrigated with a...もっと見る Silver Nanoparticles Irrigant After successful revacularization, We will categorize patients into two groups :
groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the wound with silver nanoparticle spray for 15 minutes (time needed for its absorption) before applying NPWT with foam soaked in silver nanoparticle spray) and group B (The patient's wounds will be cleaned and irrigated with a...もっと見る |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
time to complete wound healingduring | during 1 year follow up period |
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
40 Years
対象性別
全て
- Patient with critical limb ischemia(CLI) Rutherford stage 6 or Fontaine stage 4. Wounds classified as Wagner classification grade 2 to 4.Successful revascularization was confirmed by imaging and clinical assessment.
- 1. Patients with active infection(pus discharge and still need debridement), osteomyelitis.
2. patients who are allergic to silver or any components used in NPWT. 3. patients who are unable to follow up with us. patient
責任者
Mohab Mohamed Abdelfattah Saeed, 主任研究者, Lecturer, Kafrelsheikh University
連絡先情報がありません。
1 1カ国の場所
Kafrelshaykh Governorate
Kafr El Shaykh University, Kafr ash Shaykh, Kafrelshaykh Governorate, 33511, Egypt