Efficacy of a New Composition (BU002) for Debridement of Chronic Cutaneous Ulcers
New Product for the Simple, Rapid, and Effective Debridement of Skin Ulcers
This study is testing a new liquid treatment for people with long-lasting (chronic) wounds, such as venous leg ulcers or diabetic foot ulcers. These wounds can be difficult to heal because they often contain dead tissue and bacteria. The new product is designed to help clean the wound and remove dead tissue, which may help the wound heal better. It will be compared to a commonly used treatment called Polyhexanide gel.
About 80 people aged 60 years or older will take part in this study. Each participant will be randomly assigned (like flipping a coin) to receive either the new treatment or the standard treatment. Neither the participant nor most of the study team will know which treatment is being used during the study to ensure fair results.
The study will last 4 weeks. Participants will attend eleven visits at the wound care center. During these visits, trained nurses will clean and treat the wound. The study team will:
- Measure the size of the wound
- Take small samples from the wound to check for bacteria
- Ask questions about pain and general health
- Check blood flow in the legs
- Perform blood tests at the beginning A specialist doctor will examine the wound at the start and at the end of the study to see how it has improved.
Overall, this study aims to find out if the new treatment can help wounds heal better and more quickly than current standard care.
Taking part in the study is completely voluntary. Participants can leave the study at any time without affecting their usual medical care. All personal and medical information will be kept confidential.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：María B Olivares, PhD
- 電話番号：3634 562223279634
- メール：molivares@udd.cl
研究場所
-
-
Metropolitana de Santiago
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Santiago、Metropolitana de Santiago、チリ
- 募集
- Universidad del Desarrollo
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コンタクト：
- María B Olivares, PhD
- 電話番号：3634 562223279634
- メール：molivares@udd.cl
-
主任研究者：
- Daniela Constanza Espinoza, Nurse
-
副調査官：
- Isabel Aburto, Nurse
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria
A pure or mixed venous ulcer, or a diabetic, neuropathic, or neuroischemic foot ulcer, greater than or equal to 4 cm² and less than or equal to 30 cm² with critical colonization.
A duration of the ulcer greater than or equal to 2 months and less than or equal to 2 years.
Age over 60 years: due to the higher prevalence of ulcers in adults over 60 years of age.
An ankle-brachial index between 0.6 and 1.3.
Exclusion criteria
Morbid obesity (BMI > 35)
History of cancer treatment in the last year
Uncontrolled diabetes (Glycated Hemoglobin above 10 mg/dL)
Uncontrolled hypertension (blood pressure readings greater than 140/90 mmHg)
Patients with a known allergy to the components of the products under study.
Patients with signs of infection or undergoing antibiotic therapy.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：BU002
Participants will received BU002 as debridement treatment.
|
BU002 is a composition intended for debridement and antibiofilm in wounds.
他の名前：
|
|
アクティブコンパレータ：Polihexanide Gel
Participants will received Polihexanide gel as debridement treatment.
|
Polihexanide combined with betaine is a debridement and antibiofilm comercial product.
|
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 wound area
時間枠：Baseline, 4 weeks
|
The total wound area it will be measure by an image software (Ekare Insight)
|
Baseline, 4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in wound area covered by slough and necrotic tissue
時間枠：Baseline, 4 weeks
|
The area will be measured by an image software (Ekare Insight)
|
Baseline, 4 weeks
|
|
Change in wound bacterial load
時間枠：Baseline, 4 weeks
|
The bacterial burden will be measure by swab sampling, then culturing to determine colony forming units.
|
Baseline, 4 weeks
|
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 (実際)
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
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。