Difficult-to-heal WoundsNCT05953935
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
A study testing OKTO and Standard clinical procedures in people with Difficult-to-heal Wounds, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult-to-heal Wounds
- What is being tested?
- OKTO and Standard clinical procedures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jan 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Resistive Capactive Electrical Transfer Therapy On Wound Healing And Biomarker Expression In Difficult-to-heal Wounds
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).
Read the 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.
- Conditions
- Difficult-to-heal Wounds
- Being tested
- OKTO, Standard clinical procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKTODevice
Static Monopolar Capacitive Resistive Resistive Radiofrequency Equipment at 448 kHz
Standard clinical proceduresDevice
standard clinical procedures
| Study group | Role | What they receive |
|---|---|---|
| A-E group | Experimental | 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. Receives: Device: OKTO; Device: Standard clinical procedures |
| B-E group | Experimental | Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments in patients with diabetic foot ulcers. Receives: Device: OKTO; Device: Standard clinical procedures |
| A-C grouop | Experimental | Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments in CDH. Receives: Device: OKTO; Device: Standard clinical procedures |
| B-C grouop | Experimental | Treatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under subthermal conditions plus standard clinical treatments in CDH. Receives: Device: OKTO; Device: Standard clinical procedures |
| C-C group | Experimental | 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. Receives: Device: Standard clinical procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (4)
General clinical evaluation:
- age,
- sex,
- BMI
- general medical history,
- baseline blood work,
- usual treatment
Measured: 18 months
Wound evaluation:
- cause,
- location,
- time of evolution,
- photographs.
Measured: 18 months
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.
Measured: 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:
- 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start31 Jan 2024
- Primary completion31 Jul 2024
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult-to-heal WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Luisa Hernández Bule, PhD, Principal investigator, IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953935
- Sponsor's protocol ID
- CRET-ÚLCERAS-01
- Status last verified
- Jul 2024
- First submitted
- 29 Jun 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Resistive Capactive Electrical Transfer Therapy On Wound Healing And Biomarker Expression In Difficult-to-heal Wounds
- ClinicalTrials.gov ID
- NCT05953935
- Acronym / sponsor ID
- CRET-ÚLCERAS-01
- Conditions
- Difficult-to-heal Wounds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- 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)
| Arm | Type | Receives |
|---|---|---|
| A-E group | Experimental | Device: OKTO, Device: Standard clinical proceduresTreatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments, in patients with ulcers of venous etiology. |
| B-E group | Experimental | Device: OKTO, Device: Standard clinical proceduresTreatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments in patients with diabetic foot ulcers. |
| A-C grouop | Experimental | Device: OKTO, Device: Standard clinical proceduresTreatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under hyperthermia conditions plus standard clinical treatments in CDH. |
| B-C grouop | Experimental | Device: OKTO, Device: Standard clinical proceduresTreatment with radiofrequency currents of resistive capacitive electrical transfer therapy (CRET) under subthermal conditions plus standard clinical treatments in CDH. |
| C-C group | Experimental | Device: Standard clinical proceduresStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKTOStatic Monopolar Capacitive Resistive Resistive Radiofrequency Equipment at 448 kHz | Device | A-C grouop, A-E group, B-C grouop, B-E group |
| Standard clinical proceduresstandard clinical procedures | Device | A-C grouop, A-E group, B-C grouop, B-E group, C-C group |
Primary outcome
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.
Time frame: 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.
4 secondary outcomes
General clinical evaluation:
Time frame: 18 months
Wound evaluation:
Time frame: 18 months
Evaluation of biomarkers in peripheral blood of patients with CDH with or without CRET treatment:
Time frame: 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:
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Difficult-to-heal Wounds
Recruiting
Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds
Wounds and Injuries / Mortality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Luisa Hernández Bule, PhD principal investigator
IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OKTO and Standard clinical procedures in people with Difficult-to-heal Wounds, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.