- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03077893
Study of PEMF to Evaluate VPT and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy
A Multi-Center, Sham-Controlled, Double-Blind Randomized Withdrawal Study of PEMF Therapy to Evaluate Vibration Perception Threshold and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy in the Lower Extremity
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Arizona
-
Phoenix, Arizona, 미국, 85015
- Associated Foot & Ankle Specialists, LLC
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subject age is greater than or equal to 22 years and less than 80 years of age.
- Subject has documented Type 1 or Type 2 diabetes mellitus (receiving insulin, diet controlled, or taking parenteral hypoglycemic agents)
- Subject is on a stable antidiabetic regimen (medication and/or diet) to control their diabetes for at least 30 days prior to Screening.
- Subject has an HbA1c <10% at Screening or within 2 months of Screening.
- Subject has daily pain attributed to bilateral symmetrical Diabetic Peripheral Neuropathy with numbness, tingling, and/or burning based on clinical judgement for at least 6 months prior to screening.
- Subject's pain or discomfort from DPN is identifiable.
- Subject is in pain Phase 2, 3, or 4 as per the Phasing of Neuropathy Scale.
- Subjects average pain over the last 24 hours is ≥3 based on the 11-point Numeric Pain Rating Scale (NPRS) at the Screening Visit.
- Subject has adequate lower extremity pulse in both feet and no intermittent claudication.
- Subject is able to ambulate independently without assistive devices.
- Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
- Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing (or agrees to practice) an effective method of birth control if they are sexually active for the duration of the study (Effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization).
Exclusion Criteria:
- Subject is in pain Phase 1 or 5 as per the Phasing of Neuropathy Scale.
- Subject has an active, open ulcer on the lower extremities.
- Subject has peripheral vascular disease defined as absence of more than one foot pulse per foot and/or ABI <0.8 and >1.4 and/or history of angioplasty or peripheral bypass surgery within 6 months of the Screening Visit.
- Subject has venous insufficiency as classified by the Venous Insufficiency Classification System of grade C6.
- Subject has undergone nerve decompression surgery on the lower extremities.
- Subject has a history of previous kidney, pancreas, cardiac transplantation, or severe renal disease.
- Subject has been diagnosed with non-diabetic chronic inflammatory neuropathic disease (e.g. end stage renal disease, hepatitis C, chemotherapy induced neuropathy, known connective tissue disease, systemic lupus).
- Subject has peripheral vascular disease requiring revascularization of lower limb or amputation or evidence of ulcer amputation.
- Subject has clinically significant cardiovascular disease within 6 months prior to screening (unstable or poorly controlled hypertension, transient ischemic attack, MI, unstable angina, arrhythmia, any heart surgery, stent placement, heart disease).
- Subject has a history of any uncontrolled medical illness that in the Investigators judgment places the subject at unacceptable risk for receipt of PEMF therapy.
- Subject requires or anticipates the need for surgery of any type or travel during the treatment period.
- Subject has a total foot depth (most inferior aspect of the medial malleolus to the plantar aspect of the foot when residing on a treatment pad) of >8 cm.
- Subject has received any investigational drug or device within 30 days prior to the Screening Visit or within 6 weeks prior to the Screening Visit for long acting lidocaine injection products.
- Subject has used systemic corticosteroids within 3 months of the Screening Visit.
- Subject has a history of malignancy within the past 5 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area and/or localized in situ carcinoma of the cervix.
- Subject has a serious psychosocial co-morbidity.
- Subject has a history of drug or alcohol abuse, as confirmed by urine drug screen, within one year prior to the Screening Visit.
- Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
- Subject is currently pregnant or planning on becoming pregnant prior to Day 121.
- Subject has previously treated with PROVANT® Therapy System within 60 days on the lower extremity.
- Subject is unwilling or unable to follow study instructions or comply with the treatment regimen, diary documentation, and study visits.
- Subject has pain from any other source that can confuse the assessment of the pain associated with DPN.
- Subject has a clinically significant foot deformity (Charcot's syndrome or club foot).
- Subject has received nerve blocks for neuropathic pain within 4 weeks of the Screening Visit.
- Subject has been diagnosed with mononeuropathy.
- Subject has a skin condition that could alter their sensation.
- Subject has had a previous surgery to the spine or lower extremity with residual symptoms of pain or difficulty with movement.
- Subject has moderate or severe arthropathy (RA, OA, Gout) that causes discomfort during casual walking or stair climbing.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 활성 그룹
적극적인 Provant Therapy System을 통한 치료
|
적극적인 Provant Therapy System을 통한 치료
|
가짜 비교기: Sham Group
Treatment with Inactive (sham) Provant Therapy System
|
Treatment with Inactive (sham) Provant Therapy System
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Vibration Perception Threshold (VPT)
기간: Baseline to End of Treatment (Day 121)
|
A non-invasive test used in quantifying sensation/sensitivity to vibration in evaluating sensory dysfunction associated with diabetic neuropathy
|
Baseline to End of Treatment (Day 121)
|
Quantitative Sensory Testing (QST)
기간: Baseline to End of Treatment (Day 121)
|
QST is a noninvasive test used in peripheral nervous system disorders for thermal sensory testing.
|
Baseline to End of Treatment (Day 121)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Nerve Conduction Velocity (NCV) - Velocity
기간: The sural nerve conduction velocity will be recorded at the Enrollment Visit and end of study visit (Day 121).
|
NC-stat® DPNCheck® will be used to record NCV at Baseline and Day 121.
Outcome Measure Data table displays change in NCV from Baseline to Day 121.
|
The sural nerve conduction velocity will be recorded at the Enrollment Visit and end of study visit (Day 121).
|
Skin Perfusion Pressures (SPP)
기간: SPP will be conducted at the Enrollment Visit, Day 61, and end of study visit (Day 121).
|
The Vasamed Sensilase PAD-IQ will be used to record SPP.
This machine measures pressure (in mm Hg) of microcirculation using a laser Doppler sensor.
Outcome Measure Data Table below displays change from Baseline to Day 121.
|
SPP will be conducted at the Enrollment Visit, Day 61, and end of study visit (Day 121).
|
Pain Intensity (PI)
기간: Collected as patient-reported outcomes on a paper diary and at the Enrollment visit to obtain a baseline value and on Days 61, 75, and 91
|
Mean change from Baseline to Day 121, using a validated 11-point Numeric Pain Rating Scale (NPRS) with scores 0-10, where 0 = no pain and 10 = worst possible pain.
|
Collected as patient-reported outcomes on a paper diary and at the Enrollment visit to obtain a baseline value and on Days 61, 75, and 91
|
Brief Pain Inventory (BPI); Question on Pain Right Now.
기간: Change in BPI, pain right now question, from Baseline to Day 121.
|
The BPI long form will be administered at the Enrollment Visit, Day 30, 61, 91, and end of study visit (Day 121).
Results for question #15 on Pain Right Now displayed below.
Subject were asked to rate pain right now on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
|
Change in BPI, pain right now question, from Baseline to Day 121.
|
Brief Fatigue Inventory (BFI)
기간: Change from Baseline to Day 121 in BFI.
|
A 4-question assessment that assesses the level of fatigue and the impact of the fatigue on daily function over the last 24 hours.
BFI is patient reported and collected at the Enrollment Visit, Days 30, 61, 91, and end of study visit (Day 121).
A global fatigue score was calculated by averaging all of the values on the questionnaire and results for the change from Baseline to Day 121 are displayed below.
The scale ranged from 0 (no fatigue/does not interfere) to 10 (as bad as you can imagine/completely interferes).
|
Change from Baseline to Day 121 in BFI.
|
Patient Global Impression of Change (PGIC)
기간: PGIC results at Day 121 displayed below.
|
A 7-choice validated categorical scale of overall change in status since initiation of treatment with the study device.PGIC was collected every 7 days in the paper diary, immediately following the morning treatment.
Subjects were asked: Since the start of the study, my overall status is? Choices on the scale included: Very much worse, much worse, minimally worse, no change, minimally improved, much improved and very much improved.
|
PGIC results at Day 121 displayed below.
|
Hospital Anxiety and Depression Scale (HADS)
기간: Change in Depression and Anxiety from Baseline to Day 121.
|
A patient reported 14 question assessment that detects the status of depression and anxiety.
Subjects completed the assessment at the Enrollment Visit, Days 30, 61, 91, and end of study visit (Day 121).
The total score for anxiety and the total score for depression was calculated at Day 121.
Low scores represent normal (0-7) while high scores represent abnormal (11-21).
|
Change in Depression and Anxiety from Baseline to Day 121.
|
Neuro-QoL
기간: Change in each domain from Baseline to Day 121 is displayed below.
|
A validated set of health-related quality of life measures that are domain specific.Subjects will completed 6 domains: (1) Pain, (2) Lost/Reduced Feeling, (3) Diffuse Sensory Motor Symptoms, (4) Restrictions in Activities of Daily Living, (5) Disruptions in Social Relationships, and (6) Emotional Distress.The short forms were completed by the subject at the Enrollment Visit and end of study visit (Day 121). Each question in the domain was rated on a symptom scale from 1 (never) to 5 (all the time) and a bothersome scale from 1 (none) to 3 (very much). The total score for the domain was calculated by multiplying the symptom score by the bothersome score. The scale range is from 1 to 15 where the minimum (best/least symptomatic) score is 1 and the maximum (worst/most symptomatic) score is 15. |
Change in each domain from Baseline to Day 121 is displayed below.
|
Nerve Conduction Velocity (NCV) - Amplitude
기간: The sural nerve conduction amplitude will be recorded at the Enrollment Visit and end of study visit (Day 121).
|
NC-stat® DPNCheck® will be used to record NCV at Baseline and Day 121.
Outcome Measure Data table displays change in NCV from Baseline to Day 121.
|
The sural nerve conduction amplitude will be recorded at the Enrollment Visit and end of study visit (Day 121).
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Arthur Tallas, DPM, Associated Foot & Ankle Specialists, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
당뇨병성 말초신경병증에 대한 임상 시험
-
C. R. Bard완전한
-
Mayo Clinic초대로 등록
적극적인 프로반트 치료 시스템에 대한 임상 시험
-
St. Joseph's Healthcare HamiltonUnity Health Toronto; Ontario Ministry of Health and Long Term Care; Women's College Hospital 그리고 다른 협력자들종료됨