Cohort Study of PPP Injections for Athletes With Muscle Injury
2026年5月4日 更新者：University of Colorado, Denver
Prospective Cohort Study of Athletes Following an Injection of Platelet-Poor Plasma Into an Acute Muscle Injury
The investigators hypothesize that a single injection of platelet-poor plasma (PPP) into an acute muscle injury will significantly improve local muscle regeneration and patient outcomes compared to the standard of care using only ultrasound-guided hematoma aspiration.
Muscle regeneration will be assessed through quantitative MRI analysis.
The investigators anticipate that PPP injections will lead to a measurable reduction in scar tissue and an increase in regenerated muscle tissue at the injury site over a six-month period.
調査の概要
研究の種類
介入
入学 (推定)
90
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。
研究連絡先
- 名前：Jason L Dragoo, MD
- 電話番号：303-724-1055
- メール：J.DRAGOO@CUANSCHUTZ.EDU
研究連絡先のバックアップ
- 名前：Inverness Clinical Trials
- メール：Inverness.clinicaltrials@cuanschutz.edu
研究場所
-
-
Colorado
-
Englewood、Colorado、アメリカ、80112
- University of Colorado | Steadman Hawkins Clinic Denver
-
コンタクト：
- Jason L Dragoo, MD
- 電話番号：720-872-4836
- メール：J.DRAGOO@CUANSCHUTZ.EDU
-
コンタクト：
- Inverness Clinical Trials
- 電話番号：720-872-4836
- メール：Inverness.clinicaltrials@cuanschutz.edu
-
-
Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
-
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa
-
-
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
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age between 18 and 45 years
- Diagnosis of a muscle strain in the lower extremities, including but not limited to hamstring, quadriceps, and gastrocnemius
- Injury occurred within 10 days of the initial clinical evaluation
- Injury occurred while engaging in athletic or sporting activities
- Participants must be willing to undergo prescribed physical therapy
- Participants have agreed to standard-of-care management for their injury, which may include ultrasound-guided aspiration with or without a platelet-poor plasma injection
Exclusion Criteria:
- Previous injection at the injury site.
- Pregnant or breastfeeding women, or women who may become pregnant during the study duration
- Injuries resulting from puncture or crush trauma
- Injuries occurring more than 10 days prior to the injection date
- Injuries not caused by athletic or sporting activity
- Previous muscle injury in the same muscle group within 6 months
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：PPP Injection Treated Arm
US-guided aspiration of hematoma (if present) and injection of small volume (1-6cc's) of autologous platelet poor plasma (PPP) at the site of injury and post-injection physical therapy.
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US-guided aspiration of hematoma (if present) and injection of small volume (1-6cc's) of autologous platelet poor plasma (PPP) at the site of injury and post-injection physical therapy.
|
|
介入なし：No Injection Arm
Standard of care pathway with US-guided aspiration of hematoma (if present) and physical therapy only.
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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 Scar Tissue Volume at the Muscle Injury Site as Measured by Quantitative MRI Mapping
時間枠：Baseline MRI and 6-month follow-up MRI
|
Scar tissue volume at the site of acute muscle injury will be measured using quantitative mapping magnetic resonance imaging (MRI). MRI images will be segmented using software to identify abnormal (scar) tissue within the injured muscle. Scar tissue volume will be calculated in cubic centimeters (cm³). This outcome measure represents the change in scar tissue volume, calculated as the difference between baseline MRI and 6-month follow-up MRI measurements. A lower scar tissue volume indicates greater muscle regeneration and reduced fibrosis. |
Baseline MRI and 6-month follow-up MRI
|
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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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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 (推定)
2026年5月1日
一次修了 (推定)
2030年6月1日
研究の完了 (推定)
2030年12月31日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年4月28日
最初の投稿 (実際)
2026年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月6日
QC基準を満たした最後の更新が送信されました
2026年5月4日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 22-1841
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?
未定
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
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。