이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

모병

정황

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

중재적

등록 (추정된)

137

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Madrid
      • Madrid, Madrid, 스페인, 28034
        • 모병
        • Hospital Ramón y Cajal
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 18 years of age or older

  • Agree to participate in the study and sign the informed consent form.

  • Inpatients or outpatients who can be followed by the research team for the duration of the study

  • 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.

  • 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).

  • 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.
  • 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

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 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

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

결과 측정
측정값 설명
기간
General clinical evaluation:
기간: 18 months
  • age,
  • sex,
  • BMI
  • general medical history,
  • baseline blood work,
  • usual treatment
18 months
Wound evaluation:
기간: 18 months
  • cause,
  • location,
  • time of evolution,
  • photographs.
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
  • Death: TUNEL assay; Bcl-2, Bcl-X and Caspase-3 markers.
  • Viability/proliferation: XTT, Ki67, p-p38 and p-ERK1/2 assays.
  • Adhesion: β -catenin and E-cadherin.
  • Extracellular matrix: α-SMA, Col I and Col III and the metalloproteinases, MMP8, MMP2 and MMP9.
18 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Maria Luisa Hernández Bule, PhD, IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 1월 31일

기본 완료 (실제)

2024년 7월 31일

연구 완료 (추정된)

2027년 6월 1일

연구 등록 날짜

최초 제출

2023년 6월 29일

QC 기준을 충족하는 최초 제출

2023년 7월 18일

처음 게시됨 (실제)

2023년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CRET-ÚLCERAS-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .