Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
2021년 6월 29일 업데이트: Tactile Medical
Physiologic Response to Varying Lymphoedema Compression Programs With the Flexitouch System
Proof of principle study in order to determine if there is a difference in treatment effect across the 3 study groups when treating lower extremity lymphoedema using a pneumatic compression device.
연구 개요
상태
완전한
상세 설명
This is a single center, 3 arm, prospective, randomized, clinical trial to assess the difference between 3 treatment options for achieving a measurable physiologic effect on lower extremity lymphedema with pneumatic compression device.
Each intervention arm will include 10 completed subjects for a total of 30 completed subjects.
연구 유형
중재적
등록 (실제)
21
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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Derby, 영국, DE22 3NE
- Royal Derby Hospital
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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:
- Subjects must be ≥ 18 years old
- Subjects must have a diagnosis of primary or secondary Stage 2 unilateral or bilateral lower extremity lymphoedema
- Must currently be using adequate compression garment(s) as determined by the clinician: (Garments must be at least 20mmHg and no more than 3 months old and must be worn upon rising and removed at bedtime)
- Subjects must have clinically relevant excess limb swelling as determined by clinician "pitting test"
- Must be able to attend all required in-clinic treatment visits
Exclusion Criteria:
- Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy, or primary surgery for the treatment of cancer
- Active infection or inflammation
- Active thrombophlebitis (within the last 2 months)
- History of pulmonary embolism (within the last 2 months)
- Documented history of deep chronic venous insufficiency or deep venous obstruction with a reflux duration of > 2 second in the deep system or any history of deep vein thrombosis (DVT)
- History of pulmonary edema
- History of congestive heart failure
- History of chronic kidney disease with a glomerular filtration rate (GFR) of less than 30 mls per minute
- Poorly controlled asthma
- Symptomatic or severe peripheral artery disease (defined by current lifestyle-limiting claudication or critical limb ischemia)
- Presence of an open wound or ulcer of any etiology
- Diagnosis of lipoedema and lipolymphoedema
- Currently using an in-home pneumatic compression device
- Metal implant(s) that would interfere with bioimpedance equipment
- Pacemaker or other implanted electronic device(s)
- Unable or unwilling to remove bandaging from treatment regimen while participating in the study
- Pregnant
- Any condition where increased venous and lymphatic return is undesirable
- Unable or unwilling to participate in all aspects of the study protocol and/or unable to provide informed consent
- Currently participating in another clinical trial
- Currently using diuretics
- BMI > 40
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: pneumatic compression - 1 hour per day
Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.
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Pneumatic compression treatment once per day (1 hour)
다른 이름들:
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실험적: pneumatic compression - 2 hours per day
Pneumatic compression device - 5 consecutive days undergoing 1 hour treatment in the am and 1 hour of treatment in the pm.
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pneumatic compression treatment twice per day in the AM & PM (2 hours)
다른 이름들:
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실험적: pneumatic compression - 4 hours per day
Pneumatic compression device - 5 consecutive days undergoing treatment twice per day consisting of 2 consecutive 1 hour treatments in the am and the pm (4 hours total)
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pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM & PM (4 hours)
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Limb Volume (ml)
기간: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Limb volume changes measured via perometry reported in change of ml of fluid.
A negative value is associated with the clinically-desirable decrease in fluid.
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Limb Volume (% Change)
기간: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Limb volume changes measured via perometry reported in percent reduction.
A negative value is associated with the clinically-desirable decrease in fluid.
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Change in Skin Tone
기간: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Change in skin tone (fibrosis) measured via tonometry.
The tonometer is a mechanical device that gives an indication of the resistance of tissue to compression.
It is used in lymphedema to give an estimate of the extent of pitting and fibrotic induration.
Tonometry measures were collected at 5 anatomical locations.
A negative value is associated with a clinically desirable decrease in tone.
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Patient Reported Outcomes - MYMOP
기간: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Changes in patient-determined symptoms* and change in affect the symptoms had on the subject. Measured via MYMOP (Measure Yourself Medical Outcome Profile) questionnaire. A low score indicates a good outcome. Scores range from 0 (as good as can be) to 6 (as bad as can be). *Recorded symptoms were: Gr A, 1st symptom: none, abdominal pain and discomfort, swelling, physical, and worrying about granddaughters Gr B, 1st symptom: arthritis, hayfever, look of fat foot, right hand area of neck and shoulder, stairs, and swelling Gr C, 1st symptom: none, energy during dancing and gardening, frustration of not going out on own, swelling, mild longstanding depression, and MPT joint at base of small toe Gr A, 2nd symptom: fatigue, heaviness of leg, mental, and pain under knee Gr B, 2nd symptom: narrowed choice of footwear, shower in bath, and swollen left foot Gr C, 2nd symptom: being tired and aching all over, and shoes and clothing |
Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cellular Fluid Changes (Ohms)
기간: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
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Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance.
A negative number is indicative of a clinically desirable reduction in ECF.
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Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
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Cellular Fluid Changes (% Change)
기간: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
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Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance.
A negative number is indicative of a clinically desirable reduction in ECF.
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Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
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Incidence of Complications
기간: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Number of complications experienced.
Incidence based on clinician assessment.
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Activity Level
기간: Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
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Change in number of steps as accumulated each day monitored through use of a pedometer.
A positive number indicates an increase in step count (activity) while a negative number indicates a decrease in step count.
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Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Skin Thickness
기간: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Change in skin thickness measured by ultrasound.
Ultrasound measures were collected at 5 anatomical locations.
A negative value is associated with a clinically desirable reduction in skin thickness (a surrogate measure of oedema).
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Change in Local Tissue Water (LTW)
기간: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Change in local tissue water (LTW) within the skin measured by MoistureMeterD (MMD).
MMD measures were collected at 5 anatomical locations using 2 probes: medium (M25) and large (L50).
A negative value is associated with a clinically desirable decrease in LTW (a surrogate measure of oedema).
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Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Vaughan Keeley, PhD, FRCP, Royal Derby Hospital
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)
2013년 11월 11일
기본 완료 (실제)
2019년 3월 31일
연구 완료 (실제)
2019년 6월 30일
연구 등록 날짜
최초 제출
2014년 1월 7일
QC 기준을 충족하는 최초 제출
2014년 1월 7일
처음 게시됨 (추정)
2014년 1월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 7월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 6월 29일
마지막으로 확인됨
2021년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 4010 FlexDose
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