- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00854516
Open Label Clinical Study to Assess the Clinical Safety of a New Compression Device in Subjects With Peripheral Arterial Vascular Disease
Open Label Clinical Study to Assess the Clinical Safety of a New Compression Procedure in Subjects With Peripheral Arterial Vascular Disease
연구 개요
상태
상세 설명
Venous leg ulcers represent a very common clinical problem with increasing prevalence in an aging population. It is believed that venous insufficiency is the underlying condition responsible for 54-81% of leg ulcers. About 8% of leg ulcers are related to arterial insufficiency and about 14% have a mixed aetiology. Compression therapy is considered the most effective treatment for these ulcers. The overall cost of chronic venous leg ulcer is high because long term ongoing care is required. Also the quality of life of these patients is jeopardized due to long lasting ulcer treatments and inconvenient compression therapies.
Several compression products are available on the market and there is a large body of literature describing the clinical benefit of different compression systems.
A new treatment approach with the new device is to have an effective working pressure combined with a low resting pressure. A high working pressure achieved by a rigid sleeve around a patient's leg is essential to support the muscle pump, necessary for sufficient blood reflux. However the resting pressure could be low without relevant reduction of compression efficacy but with an increase in safety for patients with a mild to moderate peripheral arterial occlusive disease (PAOD). A high resting pressure is believed to be a main reason for reduced arterial skin perfusion which can result in pressure related skin damage. Accordingly most compression systems are not indicated for patients with an ABPI lower than 0.8. About 25% of patients with chronic venous insufficiency suffer from PAOD and hence are very difficult to treat with compression. With the new device, these patients could be sufficiently treated, because a low resting pressure is believed to have low influence on skin perfusion.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Greifswald, 독일, 17487
- Universitaetsklinikum Greifswald
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Males or females, age 18 years or older.
- Subjects suffering from peripheral arterial occlusive disease (PAOD) with an ABPI (ankle brachial pressure index) of the treated leg between 0.5 - 0.8 as measured within up to 4 weeks prior to enrollment. About 5 subjects of the study population should have an ABPI of 0.5.
- Subjects who are co-operative, willing to give written informed consent prior to study entry and willing to comply with the study protocol.
Subjects who can walk (with or without a walking aid).
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Exclusion Criteria:
- Subjects with an ABPI < 0.5 or > 0.8 as measured within up to 4 weeks prior to enrollment.
- Subjects whose general condition, in the opinion of the investigator, preclude for compression therapy.
- Subjects with paralysis of the study leg
- Subjects who started or significantly changed treatment with mood altering substances (e.g. antidepressant drugs) within two weeks prior to enrollment.
- Subjects with significant instable coagulopathy; subjects treated with anticoagulant therapeutics can be included.
- Subjects who are participating in any prospective clinical study that can potentially interfere with this study.
- Subjects who are, in the opinion of the clinical investigator, unsuitable for enrollment in this study, for reasons not specified in the exclusion criteria.
- Subjects with known allergies to other materials in the compression device.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The primary objective of this study is to assess the safety of the new compression device in subjects with an ankle brachial pressure index (ABPI) between 0.5-0.8.
기간: 2 weeks
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2 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Michael Juenger, Prof. Dr. MD, Universitaetsklinikum Greifswald
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .