Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Effect of Capacitive Resistive Electrical Transfer Therapy on Difficult-to-Heal Wounds

Official title: Effect Of Resistive Capactive Electrical Transfer Therapy On Wound Healing And Biomarker Expression In Difficult-to-heal Wounds

Run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · NCT05953935 · Data updated 2026-11-12

This study tests CRET therapy to see if it helps heal difficult-to-heal wounds in adults.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment137 (estimated)
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Academic / other
Drugs / interventionschemotherapy, prednisone
Locations1 site (Madrid, Madrid)
StatusRecruiting
StartedJanuary 31, 2024
Main results expectedJuly 31, 2024
Study endsJune 2027
Registry record updatedNovember 6, 2026
Trial IDNCT05953935 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years and older with lower-limb ulcers (≥0.5 cm2, ≥4 weeks), including venous chronic wounds or diabetic foot ulcers, who meet vascular/diabetes criteria and can be followed throughout the study.

Probably not a fit

Patients with wounds not responsive to CRET or lacking suitable wound characteristics may not experience a benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines whether capacitive resistive electrical transfer therapy (CRET) can promote healing of difficult-to-heal wounds in adults with venous, diabetic foot, or mixed etiologies. The therapy, delivered with the OKTO device alongside standard clinical procedures, aims to modulate inflammation and tissue regeneration to accelerate wound closure. Eligibility includes adults with ulcers of at least 0.5 cm2 persisting for 4 weeks or more, located on the lower limbs, and meeting specific vascular or diabetic criteria. Outcomes will consider wound size reduction and healing progress under standard follow-up care. The trial is conducted at Hospital Ramón y Cajal in Madrid with the Fundación para la Investigación Biomedica as lead sponsor.

Why it matters

Potential benefit: If successful, CRET therapy could offer a non-invasive, low-cost option to improve healing in difficult-to-heal wounds.

How similar studies have gone: Preliminary clinical reports and early trials suggest CRET may aid wound regeneration, but longer, controlled studies are needed for confirmation.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Hospital Ramón y Cajal
    Madrid, Madrid, Spain
    Recruiting

Study contacts

  • Principal investigator: Maria Luisa Hernández Bule, PhD — IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
  • Study coordinator: Maria Luisa Hernández Bule, PhD
  • Email: mluisa.hernandez@hrc.es
  • Phone: 913368699

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Coordinated primary-care MDT approach for hard-to-heal ulcers

    A group of adults with hard-to-heal diabetic foot ulcers will be randomly assigned to standard care or a coordinated multidisciplinary team to see if the team approach helps ulcers heal better.

    Recruiting Nordsjaellands Hospital · Hillerød · NCT07747896

  • Sorbact dressings in hard-to-heal wounds

    This study tests whether Sorbact dressings can bind bacteria and fungi from hard-to-heal wounds in adults.

    Recruiting ABIGO Medical AB · Mölndal · NCT05089890

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.