VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
2020년 2월 11일 업데이트: Tactile Medical
Randomized Trial Comparing a Dual Action Pneumatic Compression System Against Multi-Layer Bandaging Systems: A Non-Inferiority Study
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
연구 개요
상세 설명
Participants with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before being randomly assigned to either treatment using a dual action pneumatic compression device or continued multi-layer bandaging for up to 16 weeks.
Participants will be seen in clinic for treatment and evaluation of symptoms and quality of life.
연구 유형
중재적
등록 (실제)
56
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85012
- Phoenix VA Health Care System
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Phoenix, Arizona, 미국, 85015
- Associated Foot and Ankle Specialists, LLC
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Tucson, Arizona, 미국, 85710
- Arizona Regional Medical Research
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California
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Carlsbad, California, 미국, 92009
- ILD Research Center
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Fresno, California, 미국, 93720
- Limb Preservation Platform - Northwest
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Fresno, California, 미국, 93721
- Limb Preservation Platform - Downtown
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Long Beach, California, 미국, 90822
- Long Beach VA Healthcare System
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Los Angeles, California, 미국, 90024
- UCLA Medical Center
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Los Angeles, California, 미국, 90073
- Greater Los Angeles VA Healthcare System
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San Diego, California, 미국, 92161
- VA San Diego Healthcare System
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Sylmar, California, 미국, 91342
- Olive View - UCLA Medical Center
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Florida
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Miami, Florida, 미국, 33136
- University of Miami
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North Miami Beach, Florida, 미국, 33169
- Barry University Clinical Research
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South Miami, Florida, 미국, 33143
- Foot and Ankle Institute of South Florida
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Massachusetts
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Boston, Massachusetts, 미국, 02118
- Boston Medical Center
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New York
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Stony Brook, New York, 미국, 11794
- Stony Brook University
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- UNC School of Medicine
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Ohio
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Toledo, Ohio, 미국, 43606
- Jobst Vascular Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Subject must be ≥ 18 years of age or legal age at the time of enrollment.
- Chronic venous insufficiency confirmed by ultrasound within previous 12 months or prior to randomization: if subject had bilateral CVI, the limb that possessed the largest ulcer meeting study criteria was used as the study treatment limb for evaluation and documentation throughout the study. Non-study limbs received standard of care treatment as determined by the treating clinician.
- Must have at least one of the following within the past six (6) months: Dorsalis Pedis (DP) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic patients on study limb; Posterior Tibial (PT) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic patients on study limb; Transcutaneous partial pressure oxygen (TcP02) > 30mmHg; Great toe systolic pressure > 40mmHg.
- Active ulceration (CEAP classification of C6): VLU was defined by open skin lesion of the leg or foot that occurred in an area affected by venous hypertension.
- Ulcer duration: Non healing VLU ≥ 1 month but not greater than 24 months.
- Ulcer size ≥ 2cm² ≤ 50cm²: if there were multiple ulcers on the study limb, the largest ulcer was used as the study treatment ulcer for evaluation and documentation throughout the study. If two ulcers were separated by no more than one centimeter of normal skin, their areas were added together for study purposes.
- Three or fewer separate full thickness ulcers on the study limb: sum of the ulcer areas on the study limb must be ≤ 50 cm².
- Leg circumferences within the following range: Ankle - 12 to 44cm; Calf - 22 to 60cm; Below knee - 22 to 68cm.
- Able and willing to provide informed consent prior to study participation.
Exclusion Criteria:
- Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone.
- Target ulcer was of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy).
- Treatment of the target ulcer with living cellular therapy within 30 days of the time of projected randomization.
- Endovenous ablation or other venous surgery within two weeks of enrollment: venous ultrasound must be completed after procedure to determine whether there is still venous insufficiency at the time of enrollment.
- History of skin sensitivity to any of the components of ACT, multi-layer bandages of compression garments.
- History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last three (3) months.
- Acute thrombophlebitis within the last six (6) weeks.
- History of pulmonary edema or decompensated congestive heart failure within six (6) weeks of screening.
- Currently has an active infection of the skin on the target limb such as cellulitis requiring antibiotics.
- History of target limb cancer within the last 2 years with the exception of treated non-melanoma skin cancer unless ulcer biopsy performed at screening is negative for neoplasia.
- Active cancer receiving chemotherapy and/or radiation therapy.
- Poorly controlled diabetes with an HbA1c value of > 12% within the past three (3) months.
- Changes to medications that affected edema within the last 30 days prior to enrollment (e.g., diuretics, calcium channel blockers of the dihyropyridine class, pioglitazone, cox-1 inhibitors, pregabalin, and gabapentin, diltiazem, or fluctuating doses of systemic steroids).
- Use of systemic corticosteroids requiring daily administration at doses greater than 5mg of Prednisone per day or equivalent for greater than 2 weeks: low dose steroid administration (Prednisone up to 5 mg per day or equivalent) was allowable for an unlimited period of time. Topical steroid administration to peri-ulcer area or other skin was allowable but could not be applied to the ulcer itself.
- Currently pregnant or trying to become pregnant.
- Inability or unwillingness to participate in all aspects of study protocol.
- Exhibited any condition which, according to the Investigator, justified the subject's exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable.
- Currently participating in another clinical trial.
Additional Exclusion Criteria after two week run-in:
- Subject's target ulcer decreased in size by greater than 30% compared to the baseline area.
- Subject's target ulcer increased in size by greater than 50% compared to the baseline area.
- Subject's target ulcer measured less than 1.5cm² at the Randomization Visit.
- Subject appeared to have evidence of infection in any ulcer.
- The sum of the ulcer areas on the subject's study limb is > 50cm².
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Dual Action Pneumatic Compression Device
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
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Dual action pneumatic compression device used to treat chronic VLUs.
다른 이름들:
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활성 비교기: Multi-layer bandaging
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
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Multi-layer bandaging used to treated chronic VLUs
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of VLU Area Reduction
기간: Changes from Baseline to 16 weeks
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Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software.
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Changes from Baseline to 16 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient-Reported Quality of Life
기간: Changes from Baseline to 16 weeks
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The Charing Cross Venous Ulcer Questionnaire assesses the patients' perception of their health when venous ulceration is present.
All items are scored so that a lower score defines a more favorable health state (a greater reduction is associated with improved quality of life).
In addition, each item is scored using a 1 to 5 range so that the lowest and highest possible scores are 0 and 100, respectively.
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Changes from Baseline to 16 weeks
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Outpatient Costs
기간: Changes from Baseline to 16 weeks
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Assessment of the effect of the Actitouch compared to a standard regimen of multi-layer bandaging on mean total outpatient costs per subject.
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Changes from Baseline to 16 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: William Marston, MD, University of North Carolina, Chapel Hill
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 2월 1일
기본 완료 (실제)
2017년 5월 1일
연구 완료 (실제)
2017년 6월 1일
연구 등록 날짜
최초 제출
2016년 2월 9일
QC 기준을 충족하는 최초 제출
2016년 2월 11일
처음 게시됨 (추정)
2016년 2월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 2월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 2월 11일
마지막으로 확인됨
2020년 1월 1일
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. .
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