Evaluating A Non-Invasive Tissue Perfusion Monitor
2020年11月13日 更新者：Pedra Technology, PTE LTD
A Feasibility Study Evaluating A Non-Invasive Tissue Perfusion Monitor Utilising Diffuse Speckle Contrast Analysis
The Pedra perfusion system will be used to assess changes in perfusion in response to physiological stimuli.
It will be compared to other standard diagnostics.
調査の概要
詳細な説明
The Pedra perfusion system measures microvascular flow through diffuse speckle contrast analysis.
It will be used to assess changes in perfusion in response to a number of physiological stimuli.
It will be compared to other standard diagnostics including ankle-brachial index, toe-brachial index and transcutaneous oxygen measurement.
Measurements will be undertaken in non-vascular patients as well as those with chronic limb threatening ischaemia.
研究の種類
観察的
入学 (予想される)
50
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
40年～90年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Patients with palpable pulses and patients with chronic limb threatening ischaemia
説明
Inclusion Criteria:
CLTI cohort
- At least 40 years old
- Each patient will have documented arterial occlusive disease within 6 weeks of enrolment as determined by an ankle-brachial index (ABI) < 0.7 but not greater than 1.2, toe-brachial index (TBI) <0.5, skin perfusion pressure (SPP) less than 30mmHg, OR Transcutaneous oxygen measurement (TCOM) < 40mmHg in diabetics and <30mmHg in non-diabetics.
- The presence of skin breakdown compatible which with an underlying ischemic element (previous minor amputation for gangrene also included) that the Principle Investigator (PI) deems appropriate for the study.
- Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
Non-vascular group
- At least 40 years old
- Each patient will have documented palpable foot pulses
- 21 patients will be free of lower limb oedema and 6 patients will have moderate oedema present
- Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
Exclusion Criteria:
CLTI Cohort
- Subject on an investigational drug or therapeutic device within 30 days of the study visit, which in the view of the PI may compromise the study results.
- Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
- Age <40 or >90
- Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
- Has smoked cigarettes/e-cigarettes on the day of testing.
- Has taken caffeine drinks on the day of testing
- In the last 3 hours the subject has exercised beyond normal daily walking.
- Inability to have TBI measured (e.g. absence of toe)
- Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot
- Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.
Non-vascular Cohort
- Subject on an investigational drug or therapeutic device within 30 days of the study visit, which in the view of the PI may compromise the study results.
- Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
- Age <40 or >90
- Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
- Has smoked cigarettes/e-cigarettes on the day of testing.
- Has taken caffeine drinks on the day of testing
- In the last 3 hours the subject has exercised beyond normal daily walking.
- Inability to have TBI measured (e.g. absence of toe)
- Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot
- Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.
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
- 観測モデル：ケースコントロール
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Non vascular repeatibility
This cohort of patients with palpable pulses will be used to test inter- and intra- observer variability for the Pedra system
|
Diffuse speckle contrast analysis perfusion system
|
|
Non vascular physiology
This cohort of patients with palpable pulses will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli.
|
Diffuse speckle contrast analysis perfusion system
|
|
CLTI physiology
This cohort of patients with CLTI will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli.
|
Diffuse speckle contrast analysis perfusion system
|
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 |
|---|---|---|
|
The Blood Perfusion Index (unitless number) delta in response to reduction in arterial inflow pressure
時間枠：Intra-procedure
|
The range of change in the Blood Perfusion Index (unitless) in response to physiologic changes in arterial perfusion, in patients with healthy circulation and those with compromised arterial circulation
|
Intra-procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reliability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
時間枠：intra-procedure
|
The reliability of measurement of the Blood Perfusion Index will be measured and compared to standard diagnostics
|
intra-procedure
|
|
Repeatability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
時間枠：intra-procedure
|
The repeatability of measurement of the Blood Perfusion Index will be measured and compared to standard diagnostics
|
intra-procedure
|
|
Sensitivity of Pedra to detect differences in the Blood Perfusion Index between patient subsets
時間枠：Intra-procedure
|
Use of a ROC curve to assess the ability of the Blood Perfusion Index to differentiate between those with healthy circulation and those with arterial disease
|
Intra-procedure
|
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。
協力者
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 (予想される)
2020年12月7日
一次修了 (予想される)
2021年4月1日
研究の完了 (予想される)
2021年7月1日
試験登録日
最初に提出
2020年11月5日
QC基準を満たした最初の提出物
2020年11月13日
最初の投稿 (実際)
2020年11月16日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月16日
QC基準を満たした最後の更新が送信されました
2020年11月13日
最終確認日
2020年11月1日
詳しくは
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。