Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds (NCT05953935) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Spain137 participantsStarted 2024-01-31
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 18 months
Trial details
NCT IDNCT05953935
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal