Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers
Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers: A Randomised Controlled Trial of the "VASGARD" Device
調査の概要
詳細な説明
With an increasingly ageing population the incidence of venous ulceration is likely to rise. The negative impact of leg ulceration on patients' quality of life and on healthcare costs is well recognised. Increased prevalence combined with poor reported healing rates and high incidence of ulcer recurrence makes the development of a new treatment which could accelerate healing rates beyond that currently achieved using compression bandaging most desirable. Surface neuromuscular electrical stimulation in combination with compression bandaging may provide such a treatment.
Surface neuromuscular electrical stimulation (SNMES) is the application of an electrical stimulus to motor points in the body using electrodes placed on the surface of the skin to elicit a muscular contraction. It has been shown that SNMES of the calf muscles, when used in conjunction with compression therapy, provides improved venous flow velocities over compression therapy alone. Furthermore, the week-long effect of SNMES and compression therapy on healthy participants was found to be well tolerated by all participants and resulted in increases in stimulated venous flow and muscle strength. A combined SNMES and compression treatment protocol which stimulates peripheral venous blood flow may help to alleviate harmful venous pressures in venous leg ulcer patients and provide some degree of strengthening of the calf muscles, thus helping to accelerate the healing rates of venous ulcers.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Galway、アイルランド、000
- Department of Electronic Engineering, National University Ireland Galway
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Limerick、アイルランド、000
- Midwestern Regional Hospital
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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:
- Primary or recurrent venous leg ulcer.
- Ankle-brachial pressure index > 0.8
- Ulcer size between 1 and 200 cm2
- Patient suitable for full compression bandaging
Exclusion Criteria:
- History of symptomatic heart disease.
- Pregnancy
- Presence of implants in the lower leg or a pacemaker
- History of a neurological disorder
- Presence of any contraindications for the use of compression stockings such as severe arterial disease i.e. Ankle brachial pressure index (ABPI) <0.8
- Presence of cognitive difficulties which may prevent the patient or his/her carer from using the stimulator appropriately.
- Patients unable to provide informed consent
- Patients receiving dialysis
- Patients receiving steroids
- Patients receiving methotrexate
- Ulcer located in the area of electrode placement
- Patients in reduced compression bandaging system
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Control group
Patients randomised to the control group will, in addition to their routine compression bandaging, be given muscle stimulators for home use and instructed to apply 3x 30 minute sessions of comfortable electrical stimulation daily for 12 weeks.
The stimulators given to the control group will be set to provide minimal stimulation resulting in no visible muscular contraction.
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Compression bandaging systems apply graduated external pressure to the lower limb to promote venous return to the heart reducing venous hypertension and thereby facilitate venous ulcer healing.
他の名前：
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実験的：VASGARD stimulator
Patients randomised to this group, in addition to their routine treatment with compression bandaging, will be given muscle stimulators for home use and instructed to apply 3x 30 minute sessions of comfortable electrical stimulation daily for 12 weeks.
The intervention group stimulators will be capable of causing muscular contraction with a maximum force ranging from 30-40% of voluntary contractions.
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Compression bandaging systems apply graduated external pressure to the lower limb to promote venous return to the heart reducing venous hypertension and thereby facilitate venous ulcer healing.
他の名前：
The VASGARD device is a 2 channel muscle stimulator system designed for increasing venous blood flow.
Controlled electrical stimuli are delivered to the patient through adhesive gel electrodes placed over the motor points of muscles on the lower leg.
This elicits artificial muscular contractions which in turn increases lower limb venous haemodynamics.
他の名前：
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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 |
|---|---|---|
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Reduction in venous ulcer size
時間枠：12 weeks
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Reduction in relative ulcer size (area) for each patient over time, standardised to an initial size of 1, will be measured weekly.
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12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Acceptability of surface neuromuscular electrical stimulation
時間枠：12 weeks
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Patient and healthcare provider perceptions of the acceptability, efficacy and tolerability of the device will be evaluated through a series of semi-structured interviews
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12 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Changes in skin condition related to the application of Vasgard surface neuromuscular electrical stimulator as a measure of safety and tolerability.
時間枠：12 weeks
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The safety issues associated with using electrical stimulation on this patient group under compression bandaging will be evaluated. The following safety points will be evaluated at each visit.
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12 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Pierce A Grace, MCh FRCSI、HSE
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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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