치유가 어려운 상처에서 저항성 전기전이 요법의 효과
치유가 어려운 상처에서 저항성 전기전이 요법이 상처 치유와 바이오마커 발현에 미치는 영향 원문보기 KCI 원문보기 인용
Difficult-to-heal wounds present imbalances in cytokine production, increases in MMP expression, high levels of apoptosis, and decreases in the proliferation of cells such as fibroblasts and keratinocytes, which are involved in tissue regeneration. CRET therapy (capacitive resistive electrical transfer therapy) has been shown to generate granulation tissue in in vitro assays. In addition, available clinical case reports and preliminary clinical trial results indicate that CRET can promote the regeneration of acute wounds and DHW (difficult-to-heal wounds).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Difficult-to-heal wounds present imbalances in cytokine production, increases in MMP expression, high levels of apoptosis, and decreases in the proliferation of cells such as fibroblasts and keratinocytes, which are involved in tissue regeneration. CRET therapy has been shown to be able to generate granulation tissue in in vitro assays. In addition, available clinical case reports and preliminary clinical trial results indicate that CRET can promote acute wound regeneration and CDH.
The working hypothesis is that CRET treatment promotes the healing of CDH through its action in regulating inflammatory and regenerative processes in skin tissue. This non-invasive, cost-effective treatment, devoid of identified adverse effects, and not studied in depth so far in patients with CDH, can thus be placed in the treatment algorithms of CDH with the correct selection of candidate patients.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Maria Luisa Hernández Bule, PhD
- 전화번호: 913368699
- 이메일: mluisa.hernandez@hrc.es
연구 연락처 백업
- 이름: Almudena Cecilia Matilla
- 이메일: almudena.cecilia@salud.madrid.org
연구 장소
-
-
Madrid
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Madrid, Madrid, 스페인, 28034
- 모병
- Hospital Ramón y Cajal
-
연락하다:
- Maria Luisa Hernández Bule, PhD
- 전화번호: 913368699
- 이메일: mluisa.hernandez@hrc.es
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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18 years of age or older
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Agree to participate in the study and sign the informed consent form.
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Inpatients or outpatients who can be followed by the research team for the duration of the study
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Ulcers with a surface area of no less than 0.5 cm2 and of at least 4 weeks' duration (CDH), located on the lower limbs in the case of ulcers of venous etiology or on the foot, in the case of diabetic foot ulcers.
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For patients with ulcers of venous etiology: ulcers of venous etiology stage 2, 3 4 with diagnosis of chronic venous insufficiency with open wound CEAP IVC C6 according to CEAP classification (38).
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For patients with diabetic foot ulcers presenting:
- Type 1 and type 2 diabetics with a glycated hemoglobin (HbA1c ≤10% (in a test no longer than 3 months).
- Patients with UPD without PAD or with associated mild or moderate stage PAD (39) according to the criteria of the intersociety consensus for the treatment of peripheral arterial disease (TASC II).
- UPD Grade 1A, 1C, 2A, 2C according to the Texas classification (40).
- Patients who have required previous surgical debridement and 4 weeks have elapsed since such debridement.
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Comorbidity is defined as the presence of at least one of the following criteria:
- Smoking more than 10 cigarettes per day in the last 6 months.
- Immunosuppression: systemic treatment with high-dose corticosteroids in the previous 3 months, severe active infection in the previous month, presence of systemic or organ-specific autoimmune disease.
- Renal failure with creatinine > 2 mg/dl.
- Respiratory failure with pO2< 90 mm Hg
- Cardiac failure, grade II or higher
- Anemia or nutritional deficit
- Endocrine disruption under medical treatment
- Neuropathy in the affected area or neurological disease.
- Connective tissue diseases
- Mobility impairment
- Presence of microvascular disease
Exclusion Criteria:
- Pregnancy
- Patients with contraindications for CRET treatments (electronic implants, thrombophlebitis).
- Patients with chronic or pathological wounds that required surgical intervention.
- Ulcers with active infection according to IDSA classification in soft tissues or with clinical and/or radiological signs compatible with osteomyelitis.
- Allergies to standard wound treatment.
- Patients presenting severe renal insufficiency (Glomerular filtration rate ≤30 ml/min in analysis performed in the last 3 months).
- Patient who has presented an acute ischemic event (acute myocardial infarction or stroke, in the 3 months prior to inclusion in the study).
- Patients who present an evolving neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressants at the current moment.
- Patients treated for a chronic condition requiring the intake of strong systemic corticosteroids doses ≥ 40 mg prednisone).
- Critical non-revascularizable ischemia or TcPO2 < 25mmHg or a digital hallux systolic pressure < 50 mm Hg in diabetic foot ulcers.
- Patients who do not accept to use the prescribed unloading treatment in the case of diabetic foot ulcers.
- In the case of patients with ulcers of venous etiology, the presence of peripheral arterial disease in any of its stages.
- Patients who do not accept the indicated compressive bandage treatment, in the case of ulcers of venous etiology.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: A-E group
Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments, in patients with ulcers of venous etiology. |
Static Monopolar Capacitive Resistive Resistive Radiofrequency Equipment at 448 kHz standard clinical procedures |
|
실험적: B-E group
Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments in patients with diabetic foot ulcers. |
Static Monopolar Capacitive Resistive Resistive Radiofrequency Equipment at 448 kHz standard clinical procedures |
|
실험적: A-C grouop
Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments in CDH. |
Static Monopolar Capacitive Resistive Resistive Radiofrequency Equipment at 448 kHz standard clinical procedures |
|
실험적: B-C grouop
Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under subthermal conditions plus standard clinical treatments in CDH. |
Static Monopolar Capacitive Resistive Resistive Radiofrequency Equipment at 448 kHz standard clinical procedures |
|
실험적: C-C group
Standard clinical treatments established on the basis of the treatment standards of the International Working Group on the Diabetic Foot (IWGDF), in the case of diabetic foot ulcers (2, 3). For ulcers of venous etiology, the treatment standards according to the guidelines of the Spanish Association of Vascular Nursing and Wounds (Asociación Española de Enfermería Vascular y Heridas) will also be applied. |
standard clinical procedures |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Wound dimensions before and after treatments in patients with HDC treated with CRET therapy plus standard treatment versus patients with HDC undergoing standard treatment alone.
기간: 18 months
|
Wound dimensions measurement (area, length and width) before and after treatments in patients with HDC treated with CRET therapy plus standard treatment versus patients with HDC undergoing standard treatment alone. |
18 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
General clinical evaluation:
기간: 18 months
|
|
18 months
|
|
Wound evaluation:
기간: 18 months
|
|
18 months
|
|
Evaluation of biomarkers in peripheral blood of patients with CDH with or without CRET treatment:
기간: 18 months
|
Quantification of cytokines and growth factors: IL-1α, IL-1β, TNFα, IFγ. |
18 months
|
|
In primary cultures of fibroblasts isolated from biopsies of CDH patients with or without CRET treatment, assessment of typical CDH biomarkers related to:
기간: 18 months
|
|
18 months
|
공동 작업자 및 조사자
스폰서
스폰서
수사관
수사관
- 수석 연구원: Maria Luisa Hernández Bule, PhD, IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- CRET-ÚLCERAS-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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