Safety and Efficacy of Low Intensity Shockwave Therapy in Treating Diabetic Foot Ulcers
Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation for the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves of in accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the use of Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion rate, increased cell proliferation and cell activity and decreased cell apoptosis.
The present study deals with the effect of low intensity shockwaves on DFUs. Shockwave treatment will be done together with the standard conventional treatment for DFUs, compared to a control group who will receive the same conventional standard of care.
연구 개요
상태
정황
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Chronic non-healing diabetic foot ulcers for more than 2 months.
- Age 18-80 years
- Ankle Brachial Index (ABI) ≥0.6
- Diabetic Foot Ulcer with the long diameter of ≤7cm and a short diameter of ≥1cm
- The target ulcer is up to Wagner's grade 3
- Albumin level ≥25g/L
- Hemoglobin level ≥90g/L
- Estimated Glomerular Filtration Rate (eGFR) ≥30ml/min/1.73m2
- The patient agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the ulcer (dressings, orthotics etc.) and all follow-up visit requirements
Exclusion Criteria:
- Pregnancy or lactation
- ABI <0.6
- The long diameter of the target ulcer is >7cm and the short diameter is <1cm
- The target ulcer is of Wagner's grade 4 or above
- Severe Hypoalbuminemia <25g/L
- Severe anemia, Hemoglobin level <90g/L
- eGFR <30ml/min/1.73m2
- Patients suffering from acute Charcot foot
- Severe edema of the treated limb
- Patient with present malignancy or past malignancy in the treated area
- Systemic chemotherapy/ radiation treatment within the last 6 months
- Deep vein thrombosis within the last 6 months
Any other experimental treatment or participation in other studies
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공부 계획
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: Extracorporeal Shockwave Therapy and debridement
The treatment will be performed as an outpatient care procedure with no anesthesia.
Patients will undergo wound debridement and cleansing before each treatment.
The transducer device will be positioned against the lesion area and shockwaves will be delivered at a gradually increasing energy, with a maximum energy level of 0.09mJ/mm2
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활성 비교기: debridement and cleansing.
The standard treatment to the control group and the treatment group will be performed as an outpatient care procedure with no anesthesia.
Patients will undergo wound debridement and cleansing.
The physician will treat the patient in regard to his medical state: antibiotic medication if needed, dressing and off loading with Orthotic devices
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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To assess initial closure rate of the wound 4 weeks after the last treatment session, as compared to the control group receiving conventional standard of care.
기간: four weeks
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four weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
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. .