Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg
To Evaluate the Increase of Local Circulation in the Leg Using the Flowaid Device
This is an open label pilot study to evaluate the efficacy and the safety of the Flowaid device in increasing local circulation in the legs.
15 patients with a diagnosis of Peripheral Vascular Disease will be enrolled in this study. They will recieve tratment with the Flowaid device and monitored continuously by means of Laser Doppler Flowmetry as well as by tcPO2 and Digital Thermography. Subjective data will also be collected.
연구 개요
상세 설명
This is a 15 patient pilot study to evaluate efficacy and safety of use of the Flowaid device in increasing local circulation in the legs of patients with Peripheral Vascular Disease. Patients will be evaluated and scored prior to treatment and then treated with the Flowaid device for a period of two hours. During the treatment period patients will be continuously monitored by digital thermograph as well as by tcPO2 and Laser Doppler Flowmetry. Patients will also be monitored for a brief period immediately after cessation of treatment to evaluate continued effect of the device on local circulation in the leg.
The study will be individually controlled with each patients treated leg evaluated against the contralateral non- treated leg.
Subjective data including distance able to walk, pain and vibratory sensation threshold will also be collected and evaluated appropriately.
연구 유형
단계
- 1단계
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10035
- New York College of Podiatric Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Give appropriate written informed consent prior to participation in the study
- Have a current diagnosis of Type I or Type II Diabetes Mellitus
- Have an Ankle-Arm Index between 0.35 and 0.8 on the study limb
- Be in reasonable metabolic control, exhibited by HbA1C values of less than12% as observed by serum test results obtained within 3 months prior to the Screening Visit
- Subject and caregiver must be accessible for, and willing to comply with, the safety procedures and available for the 12 week Follow-Up Period
Exclusion Criteria:
- Clinical evidence of gangrene on any part of affected foot
- Active Charcot's foot on the study limb
- Scheduled to undergo vascular surgery, angioplasty, or thrombolysis within 30 days from the end of the study
- Malnourished as evidenced by a pre-albumin of < 11 mg/dL
- Pregnancy or lactating
- History of bleeding disorder
- Participation in another device study for the treatment of Peripheral Vascular Disease 30 days prior to Screening Visit
- Vascular procedures performed 30 days prior to Screening Visit
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
수사관
- 연구 책임자: Eileen Chusid, PHD, New York College of Podiatric Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작
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. .
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