糖尿病性足部潰瘍の管理に役立つ遠隔温度および視覚モニタリング
高リスク糖尿病足患者の管理における写真および熱モニタリングの有効性を評価する前向き観察研究
This study is a prospective, observational investigation evaluating the effectiveness of Remote ThermoVisual Monitoring (RTVM) in the early detection of diabetic foot ulcers (DFUs) in high-risk populations. The primary objective is to compare the incidence of Wagner stage 2 or higher DFUs at the time of presentation between patients using RTVM and a matched control group from a retrospective patient database.
Participants will include adults aged 18 years or older with type 1 or type 2 diabetes mellitus and a history of a plantar DFU that healed within the past five years. The study will enroll approximately 100 participants across up to 30 centers affiliated with SerenaGroup®. The intervention involves daily use of the OneStep Foot Scanner™, which measures temperature and captures visual images of the soles of the feet to detect signs of inflammation or anomalies.
Secondary objectives include evaluating ulcer-free survival, amputation-free survival, time to first evaluation for new DFUs, and healthcare utilization rates. Exploratory endpoints will assess neuropathy-specific quality of life and the costs associated with ulcer and amputation care. Participants will be monitored over a period of 12 months.
Results from this study aim to provide insights into the efficacy of RTVM as a preventative tool for managing diabetic foot health and reducing the burden of DFUs in high-risk populations.
調査の概要
詳細な説明
This study is a prospective, multicenter, observational investigation designed to assess the utility of Remote ThermoVisual Monitoring (RTVM) using the OneStep Foot Scanner™ in detecting diabetic foot ulcers (DFUs) at an earlier stage in high-risk populations. DFUs represent a significant clinical and economic burden, often leading to severe complications, including infections and amputations. Early detection and intervention are critical to reducing morbidity and improving patient outcomes.
The primary objective is to compare the incidence of Wagner stage 2 or higher DFUs at the time of presentation in participants using RTVM to a matched historical control group. The secondary objectives include ulcer-free survival, amputation-free survival, time to first evaluation for new DFUs, and healthcare utilization rates. Exploratory endpoints include assessing neuropathy-specific quality of life and evaluating the economic impact of RTVM on DFU and amputation care costs.
The study will enroll approximately 100 participants aged 18 years or older with a confirmed diagnosis of type 1 or type 2 diabetes mellitus and a history of plantar DFUs that have healed within the past five years. Eligible participants will be recruited across up to 30 SerenaGroup® clinical sites. Participants will use the OneStep Foot Scanner™ daily to capture thermographic and visual data of the soles of their feet, which will be analyzed to identify signs of inflammation, potential ulceration, or other abnormalities. The data collected will be reviewed periodically by healthcare professionals for signs requiring intervention.
Participants will be followed for a period of 12 months, during which they will undergo regular clinical evaluations and remote monitoring assessments. The study will not only evaluate the effectiveness of RTVM in reducing the severity of DFUs but also explore its impact on healthcare costs, quality of life, and overall disease management strategies.
This study aims to provide critical insights into the feasibility of implementing RTVM as a preventive tool in routine diabetic foot care and its potential role in mitigating the global burden of DFUs.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Florida
-
North Port、Florida、アメリカ、34289
- Three Rivers Wound and Hyperbaric Center
-
-
Pennsylvania
-
Monroeville、Pennsylvania、アメリカ、15146
- SerenaGroup Monroeville
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female patients 18 years or older
- Diagnosis of type 1 or type 2 diabetes mellitus
- History of a plantar DFU within 5 years of enrollment.
- Access to a phone on which they can receive study communications.
- SUBGROUP: a patient with an active Wagner grade 1 DFU may be enrolled if in the opinion of the investigator the wound is sufficiently epithelialized and can withstand the pressure applied during scanning.
Exclusion Criteria:
- Weight, when fully clothed, of greater than 300 kg (~330 lbs) NOTE: for participants over 150kg the device will need to be used from a seated position
- Active Charcot arthropathy defined as the phase where the foot is undergoing collapse
- Active foot infection or gangrene
- Critical limb threatening ischemia as evidenced by rest pain, or the presence of gangrene on any part of the foot.
- Any mental health disorder, psychiatric disorder, or alcohol or drug abuse history such that, in the opinion of the investigator, rule the patient is unreliable as a study participant
- Any travel plans expected to result in an interruption of device use for greater than 30 consecutive days.
研究計画
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：ふるい分け
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
アクティブコンパレータ：Use of device
This cohort will be recruited to use the OneStep Foot Scanner in their homes everyday for 12 months |
Daily scans with the OneStep Foot scanner will provide thermal and visual data of the soles of the feet to assist in early identification of risk factors associated with Diabetic Foot Ulcers |
|
介入なし：Control Group from Retrospective Patient Database
Patients with a history of previous DFU(s) will be matched with participants in the active arm and analyzed |
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 |
|---|---|---|
|
Number of more severe DFUs presenting
時間枠：12 months
|
Incidence of Wagner grade 2 or higher ulcer at the time of first presentation for patients with a history of DFUs that healed in the previous 5 years. |
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of time to DFU development
時間枠：12 months
|
Time to first evaluation in patients with new DFUs in a high-risk population of patients with healed (within 5 years) DFUs |
12 months
|
|
Number of Patients who Experience Ulcer Free Survival
時間枠：12 months
|
Ulcer free survival (of Wagner Grade 2 or higher ulcers), in a high-risk population of patients with recently healed DFUs. |
12 months
|
|
Number of Patients who Experience Amputation Free Survival
時間枠：12 months
|
Amputation free survival in a high-risk population of patients with recently healed DFUs |
12 months
|
|
Resource utilization
時間枠：12 months
|
Incidence of inpatient admissions, emergency room visits and outpatient provider encounters in patients with new DFUs in a high-risk population of patients with recently healed DFUs |
12 months
|
|
Compliance with Recommended Device Use as Measured by Scan Data Collected from the Bluedrop OneStep Foot Scanner
時間枠：12 months
|
Adherence with RTVM in participants assigned to use RTVM |
12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PROM
時間枠：12 months
|
Survey-ascertained participant reported quality of life measures using the NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire using a Likert scale of 1 to 5 for frequency of symptoms where 1 represents "never" and 5 represents "all the time" - with higher scores signifying a poorer quality of life. |
12 months
|
|
Resource utilization costs
時間枠：12 months
|
Costs associated with ulcer and amputation care in a high-risk population of patients with recently healed DFUs |
12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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