search
Back to results

Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds

Primary Purpose

Difficult-to-heal Wounds

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OKTO
Standard clinical procedures
Sponsored by
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Difficult-to-heal Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    A-E group

    B-E group

    A-C grouop

    B-C grouop

    C-C group

    Arm Description

    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.

    Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments in patients with diabetic foot ulcers.

    Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments in CDH.

    Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under subthermal conditions plus standard clinical treatments in CDH.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    General clinical evaluation:
    age, sex, BMI general medical history, baseline blood work, usual treatment
    Wound evaluation:
    cause, location, time of evolution, photographs.
    Evaluation of biomarkers in peripheral blood of patients with CDH with or without CRET treatment:
    Quantification of cytokines and growth factors: IL-1α, IL-1β, TNFα, IFγ.
    In primary cultures of fibroblasts isolated from biopsies of CDH patients with or without CRET treatment, assessment of typical CDH biomarkers related to:
    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.

    Full Information

    First Posted
    June 29, 2023
    Last Updated
    July 27, 2023
    Sponsor
    Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05953935
    Brief Title
    Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
    Official Title
    Effect Of Resistive Capactive Electrical Transfer Therapy On Wound Healing And Biomarker Expression In Difficult-to-heal Wounds
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Difficult-to-heal Wounds

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Single-center, prospective, randomized, interventional, pre-post clinical study with control group and seamless adaptive design. It will be conducted in two phases: 1) exploratory phase (E) and 2) confirmatory phase (C), depending on the results obtained in the exploratory phase. Patients will be randomized to control group (standard clinical procedures) and experimental group (OKTO medical device)
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    137 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A-E group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    B-E group
    Arm Type
    Experimental
    Arm Description
    Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments in patients with diabetic foot ulcers.
    Arm Title
    A-C grouop
    Arm Type
    Experimental
    Arm Description
    Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments in CDH.
    Arm Title
    B-C grouop
    Arm Type
    Experimental
    Arm Description
    Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under subthermal conditions plus standard clinical treatments in CDH.
    Arm Title
    C-C group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    OKTO
    Intervention Description
    Static Monopolar Capacitive Resistive Resistive Radiofrequency Equipment at 448 kHz
    Intervention Type
    Device
    Intervention Name(s)
    Standard clinical procedures
    Intervention Description
    standard clinical procedures
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    General clinical evaluation:
    Description
    age, sex, BMI general medical history, baseline blood work, usual treatment
    Time Frame
    18 months
    Title
    Wound evaluation:
    Description
    cause, location, time of evolution, photographs.
    Time Frame
    18 months
    Title
    Evaluation of biomarkers in peripheral blood of patients with CDH with or without CRET treatment:
    Description
    Quantification of cytokines and growth factors: IL-1α, IL-1β, TNFα, IFγ.
    Time Frame
    18 months
    Title
    In primary cultures of fibroblasts isolated from biopsies of CDH patients with or without CRET treatment, assessment of typical CDH biomarkers related to:
    Description
    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.
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds

    We'll reach out to this number within 24 hrs