- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07696728
Pulsed Electromagnetic Field Therapy for Diabetic Foot Ulcer Sensation
Effect of Low Frequency Pulsed Electromagnetic Field Therapy on Vibration Perception Threshold and Protective Sensation in Diabetic Foot Ulcer
Diabetes Mellitus (DM) is a chronic metabolic disorder characterized by hyperglycaemia for extended periods of time, which causes damage to peripheral nerves, resulting in sensory, motor and autonomic dysfunction. The study will aim to assess the effect of the Low pulse electromagnetic field therapy in VPT and protective sensation in the diabetic foot ulcer. The total number of participants will be 42 (calculated by epi tool) and the participants are to be divided among two groups. Non Probability Consecutive sampling technique will be used for this study.
The data collection tools will be Wagner Classification System for Diabetic Foot Ulcers, Numerical Pain Rating Scale, Goniometry, 10 g monofilament, Tuning Fork 128 Hz will be used. After meeting the inclusion and exclusion criteria and taking the written and verbal informed consent participants in one group will receive (low frequency pulsed electromagnatic field therapy and ankle Range of Motion) and other group will be receive (Sham PEMF and ankle Range of motion). Both interventions will be given three times weekly (or every other day) for 6 weeks. Vibrations perception, protective sensation, pain, ankle ROM and will be the outcome measures of the study. The data will be collected at baseline and 6 weeks. The data will be analyzed by using SPSS 23 and interpreted by using MS Word.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dr. Rubina Zulfqar
- 전화번호: +923414291664
- 이메일: drrubinazulfqar355@gmail.com
연구 장소
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Punjab Province
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Faisalabad, Punjab Province, 파키스탄, 38000
- 모병
- Dr Rubina Zulfqar
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연락하다:
- Dr. Rubina Zulfqar
- 전화번호: +923414291664
- 이메일: drrubinazulfqar355@gmail.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participants must have a clinical diagnosis of Type 2 diabetes (HbA1c ≥ 6.5) (Bolen et al., 2016).
- Patients with Wagner grade 1 diabetic foot ulcers was selected.
- Michigan Neuropathic Screening Instrument history score ≤7 (Viswanathan et al., 2025).
- Participants showing reduced vibration perception threshold on 128Hz Tunning fork was included to confirm the presence of sensory neuropathy Associated with diabetic ulcers (Viswanathan et al., 2025).
- Sensation on 10g monofilament less then 8 point out of 10 indicate reduces Sensation.
- Participants having diabetes for more than 10 years (Grewal et al., 2015).
- Pariticipants aged between 40 to 60 years.
- Both gender were included.
- Participants who was willing to give consent.
Exclusion Criteria:
- Participants who have significant cognitive impairment (e.g Dementia, Alzheimer) that would prevent them from understanding and adhering to Study instructions.
- Participants with active infections requiring systemic antibiotic therapy (Kwan et al., 2015).
- Patients with comorbidities such as malignancy, severe renal disease, or Other systemic condition.
- Participants who was not taking any medicine
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Group A Pulsed Electromagnetic Field Therapy and Ankle Range of Motion
Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Table 2 Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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실험적: Group B Ankle Range of Motion
Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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Parameters Description Ankle Range of Motion Active ROM
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vibration Perception Threshold
기간: 6 week
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Vibration perception threshold will be measured by using Tuning Fork 128 Hz. that check either the patient sense the vibration or not.
if person feel sensation grater than 10 second indicate decrease vibration perception.
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6 week
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Protective Sensation Score as Assessed by the 10-g Monofilament Test (0-10 Total Score).
기간: 6 weeks
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Protective sensation will be assessed using the 10-g monofilament at 10 standardized plantar sites.
One point is awarded for each site where the participant correctly perceives the monofilament, yielding a total score ranging from 0 to 10. Higher scores indicate better protective sensation.
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6 weeks
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Diabetic peripheral neuropathy
기간: 6 weeks
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Diabetic peripheral neuropathy will be measured by using Michigan Neuropathy Screening Instrument (MNSI) Physical Assessment, the decrease in score showed improvement the total score consisting of 5 per foot overall 10, 0 indicate foot is healthy and 10 indicate worse condition.
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6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Range of Motion
기간: 6 weeks
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Range of Motion will be measured by using Goniometory the increase in range shows improvement and decrease showed adverse effect.
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6 weeks
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Pain intensity
기간: 6 weeks
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Pain intensity will be measured by using Numerical Pain Rating Scale, the scale consisting of 0 to 10 number 0 means no pain 10 mean worse pain the decrease in NPRS scores reflecting decreased pain intensity and increased comfort.
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6 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TUF/EIRB/174/26
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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